Bacon’s Bits

From Stan Bacon

Stan Bacon is a graduate of the US Military Academy at West Point, NY. He contributes his time freely to  scan/scout the media for items about prostate cancer.  When he finds something he thinks would be of interest to guys with prostate cancer, he e-mails (“shotguns”) it out to those who may be interested. He has permitted us to share his findings with  you.

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Updated Analysis Confirms That Adherence To A Strict Mediterranean Diet Is Correlated To Longer Cancer Survival For Many Cancers, Including Prostate Cancer

Date: Mon, 9 Nov 2015 11:28:56 -0700

Go to any support group meeting and you are almost sure to hear someone, usually a new member of the group, ask about what they might do to lower their risk of having their prostate cancer progress or even lower their risk of dying from the prostate cancer. Among the common answer to this question that you will hear pertains to the subject of diet. The most common recommendation for diet will be to eat a Mediterranean Diet (MD).

Is this a good answer? Actually, there is a lot of research that evaluates this answer. The research is extensive and includes a large number of subjects, having many different cancers, not just prostate cancer.

There was a recent, systematic review and meta-analysis of observational studies performed to gain further insight into the effects of adherence to a Mediterranean Diet (MD) on overall cancer mortality, incidence of different types of cancer, and cancer mortality risk in cancer survivors.

The researchers performed an extensive literature search using the large electronic databases of PubMed, and EMBASE. Their analysis included studies up to July 2, 2015. They included either cohort (for specific tumors only incidence cases were used) or case-control studies. Study specific risk ratios, hazard ratios, and odds ratios were pooled.

Their updated review found and used an additional 23 observational studies that were not included in the previous meta-analysis (total number of studies evaluated: 56 observational studies). Their overall study population included 1,784,404 subjects.

They found that:

  • The highest adherence score to an MD was significantly associated with a lower risk of all-cause cancer mortality. This included colorectal cancer, breast cancer, gastric cancer, PROSTATE CANCER, liver cancer, head and neck cancer, pancreatic cancer, and respiratory cancer.
  • They also found that no significant association of cancer mortality could be observed for esophageal/ovarian/endometrial/and bladder cancer, respectively.
  • They did find that among cancer survivors, the association between the adherence to the highest MD category and risk of cancer mortality, and cancer recurrence was not statistically significant.

This updated meta-analyses does confirms the positive association provided by adherence to a MD in relation to cancer mortality and risk of several cancer types, including PROSTATE CANCER.

Cancer medicine. 2015 Oct 16 [Epub ahead of print]; Lukas Schwingshackl, Georg Hoffmann

Department of Nutritional Sciences, Faculty of Life Sciences, University of Vienna, Althanstra 14 UZA II, A-1090, Vienna, Austria. , Department of Nutritional Sciences, Faculty of Life Sciences, University of Vienna, Althanstra 14 UZA II, A-1090, Vienna, Austria.

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High-Intensity Ultrasound Device for Prostate Surgery Clears FDA

Published online October 13, 2015

The FDA has apparently approved a new primary treatment for PC – HIFU. This is the opposite of cryotherapy, which freezes PC tumors to kill them; HIFU targets the PC tumor with enough ultrasound energy to thermally kill them (with minimum damage to surrounding healthy tissues).

Perhaps a review of primary medical treatments is in order:

Local therapies:

  1. Surgery: Both manual and robotic (Da Vinci)
  2. Radiation: X-rays (IMRT and others), Protons, Neutrons, electrons (Brachytherapy – seed implants). [I have heard only once of neutron radiation and don’t know if it is FDA-approved.]
  3. Cryotherapy
  4. HIFU

Systemic therapies: Pretty much only hormone therapy (ADT). It can be used by itself or in conjunction with the local therapies above to shrink the prostate and “soften up” the PC tumor(s).

There are too many salvage therapies to list. Most research seems to be in this area – mCRPC. You would think that some salvage therapies would also qualify as primary treatments, but they all seem to require failure of a primary treatment before they can be used.

Men who are not candidates for prostate surgery because of comorbidities or other complications have another treatment option to consider. The FDA has issued a de novo clearance for a minimally invasive high-intensity focused ultrasound (HIFU) device for prostate tissue ablation called Sonablate 450 and marketed by SonaCare Medical, LLC. It marks the first approved device to use this technology in the United States, despite its approval in 49 other countries around the world, according to a statement issued by the company.

“Until now, this technology was not available in the US,” said Herbert Lepor, MD, in a statement. “It is anticipated that ablative urological surgeons in the US will quickly master and adapt this technology for their patients. HIFU offers the opportunity for the precise delivery of ablative energy to the prostate. Thus, it can be adapted to whole gland or focal gland ablation,” said Lepor, professor and Martin Spatz Chairman, Department of Urology, New York University School of Medicine.

Sonablate 450 features a fully integrated probe with dual ablation transducers that take advantage of precisely programmed robotic movements that follow the physician’s precise ablation plan. This image guidance allows for a customizable ablation plan tailored to each patient’s prostate diagnosis. This customizable plan allows the user to ablate in a wide variety of applications, including whole-gland and partial prostate ablation on men who have or have not had previous prostate procedures.

“Simultaneous advances in imaging, fusion technologies, and now more focused therapies are going to allow us to precisely diagnose prostate conditions,” said Michael Koch, MD. It affords clinicians the option to “ablate these targeted areas rather than perform whole-gland prostate surgery, which carries a significant burden on quality of life,” added Koch, who was a clinical trial investigator and is chairman of the Department of Urology at Indiana University.

Ultrasound energy is focused at a specific location in the prostate gland called the focal point. At the focal point, prostate tissue is heated to nearly 195 degrees Fahrenheit (90 degrees Celsius). The tissue at the focal point is destroyed, but the tissue surrounding the area remains unharmed. Because the technology uses ultrasound energy, not radiation, to destroy targeted tissue, the procedure can be repeated, if necessary. The minimally invasive procedure can be used to perform prostate ablations that urologists routinely perform on prostate glands up to 40cc without previously performing a TURP (transurethral resection of the prostate) procedure.

Tissue analysis is conducted via radio frequency (RF). An RF signal is sent to a targeted ablation site prior to delivery of HIFU and then another signal is sent after delivery of HIFU to the same site. The device calculates the change that took place and displays it on the screen. Tissue changes are quantified based on a comparison of RF ultrasound pulse-echo signals at each ablation site.

Another HIFU device, Ablatherm, which is marketed by EDAP TMS, is undergoing a phase III clinical trial. Patient recruitment and follow-up phases of the study are now completed, according to the company. The pre-market approval file is currently under review by the FDA.

See more at http://www.onclive.com/web-exclusives/high-intensity-ultrasound-device-for-prostate-surgery-clears-fda-hurdle

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The Quest for the Cures Continues:
The Truth about Cancer

Moderator of FVCN Cancer Support Group provided information on excellent series-“The Quest for the Cures Continues: The Truth About Cancer”.

See https://www.youtube.com/watch?v=Rc1rtIxvkao for the link to the 11 episodes; each about an hour long.

The TruthAbout Cancer:

  • Episode 1 – Modern Medicine and the Cancer Pandemic
  • Episode 2 – Your First Line of Defense
  • Episode 3 – Eliminate Those “Dirty Dozen” to Prevent Cancer
  • Episode 4 – Your Secret Fountain of Youth
  • Episode 5 – Nature’s Pharmacy
  • Episode 6 – Clean Foods & The Cancer-Free Diet: Diagnostic “Dos & Don’ts”
  • Episode 7 – Provent Treatment Protocols Part 1
  • Episode 8 – Provent Treatment Protocols Part 2
  • Episode 9 – Provent Treatment Protocols Part 3
  • Episode 10 – Doctor’s Orders
  • Episode 11 – How to Survive and Thrive

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Adding Early Docetaxel to ADT for Metastatic Prostate Cancer Improves Survival

By Kelly Young
Edited by Susan Sadoughi, MD

Adding early docetaxel to a regimen of androgen-deprivation therapy in patients with prostate cancer is associated with longer overall survival, according to a study in the New England Journal of Medicine.

Nearly 800 patients with metastatic hormone-sensitive prostate cancer were randomized to androgen-deprivation therapy with or without six cycles of concomitant docetaxel for 18 weeks.

After a median follow-up of 29 months, combination therapy was associated with 13.6 months’ longer survival than ADT alone (57.6 vs. 44.0 months). Patients with a higher burden of disease appeared to benefit the most.

Link(s):

NEJM article (Free) http://click.jwatch.org/cts/click?q=227%3B68204459%3BMupJwk7Y%2FGpzTT3JW5QSdf3lRjydO%2FTZIvsJs3H7OxY%3D

Background: Physician’s First Watch coverage of this study’s interim results (Free) http://click.jwatch.org/cts/click?q=227%3B68204459%3BMupJwk7Y%2FGpzTT3JW5QSdVnRCCYWfI7aIvsJs3H7OxY%3D

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WRNMMC Us TOO, Inc. May 2015 NEWSLETTER

See full text at http://www.cpdr.org/patient-information/ustoo/0515.pdf.

Us Too, Inc. is a Prostate Cancer Support Group sponsored by WALTER REED NATIONAL MILITARY MEDICAL CENTER

Summary of February 5 Presentation:

  • SEXUAL FUNCTION AND PROSTATE CANCER by Colonel Robert C. Dean, MD,Director of Andrology, WRNMMC starting at page 8.

Articles include:

  • High-Dose Testosterone Therapy and Advanced Prostate Cancer
  • New Studies Make Case for Prostate Cancer Drug before Chemotherapy
  • Detectable PSA after Prostatectomy Requires Aggressive Radiation Therapy
  • Surgery versus Radiation for High Risk Prostate Cancer
  • Low-Grade Prostate Cancer and Metastasis
  • Active Surveillance Outcomes Vary by Disease Risk
  • Erectile Function Recovery and Robotic Prostate Surgery
  • Vitamin D and Prostate Cancer
  • Smoking and Prostate Cancer

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prostatesnatchers

Xtandi and Zytiga, The Future is Now

Posted: 23 Jun 2015 03:08 PM PDT

MARK SCHOLZ, MD

There are two new kids on the block, Xtandi and Zytiga. Both medications are real game changers. They are special because they can induce cancer remissions in men whose prostate cancer has become resistant to Lupron. These pills are so effective that protocols for managing hormone resistant prostate cancer have been completely revamped. Previously, men with hormone resistance were first treated with Taxotere chemotherapy, typically with undesirable side effects and frequent doctor’s visits. When men on Xtandi and Zytiga are responding well, since they no longer need an intravenous infusion of Taxotere every three weeks, they only have to come in for a doctor’s visit every three months.

While Xtandi and Zytiga are now FDA approved for hormone resistant prostate cancer, there is no reason to believe they won’t also show enhanced effectiveness against earlier-stage, hormone-sensitive disease as well. This rationale is based on a long established fact about anticancer treatments in general: Any treatment that is effective against advanced cancer generally proves to be more effective against earlier-stage cancer. This assumption is so logical one might wonder why the academic medical world insists on doing studies to prove it. Honestly, the biggest barrier is probably cost. Insurance companies that pay for these expensive medications demand ironclad proof of a beneficial effect before being willing to cover their expanded use.

Physicians, particularly urologists, who are unfamiliar with these potent new agents, are another barrier to the expanded use of Xtandi and Zytiga in earlier-stage prostate cancer. Urologists, the surgeons who over the last 20 years have only slowly become familiar with how the standard medications Lupron and Casodex function, are often uncomfortable using new agents that can be associated with rare side effects such as high blood pressure, seizures, liver problems and potassium depletion. To urologists, the doctors who are managing the men with early-stage prostate cancer, Xtandi and Zytiga are relative unknowns.

In spite of all these barriers, the logical place to consider using Xtandi and Zytiga is in earlier-stage,high-risk situations which have suboptimal cure rates with Lupron alone.  The situations where this might apply are listed below:

  • Newly -diagnosed men with a PSA over 20 and a Gleason score over 8
  • Newly-diagnosed men with seminal vesicle invasion or pelvic lymph node metastases
  • Relapsed men after surgery with a PSA doubling < 3 months having salvage radiation
  • Newly-diagnosed oligometastatic disease undergoing radiation to all sites of disease 

In all these situations, Lupron is known to be beneficial. In some cases, the addition of Casodex to Lupron further increases the anticancer effect over Lupron alone. This is an important observation because compared to Xtandi or Zytiga, Casodex is a very weak anticancer agent. Substituting these far more potent agents for Casodex is very likely to result in substantial improvement of the anticancer benefit and is a logical consideration for men who want to optimize their cure rates.

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 Blood Test for Prostate Cancer Investigated

Tech Digest
January 6, 2015

Vanderbilt University researcher William Mitchell, MD, PhD, and colleagues in Germany and Canada have demonstrated a method for detecting “cell-free” tumor DNA in the bloodstream.

Mitchell believes the technique will be transformative in providing improved cancer diagnostics that can both predict treatment outcomes and monitor patient responses to therapy.

In a large retrospective study of blood samples, the researchers showed that the method, called a “liquid biopsy,” could accurately distinguish prostate cancer from normal controls without prior knowledge of the genetic “signature” of the tumors, and with over three times the sensitivity of current prostate-specific antigen (PSA) screening.

The study appears in the January issue of Clinical Chemistry (volume 61, page 239), which is dedicated to “Molecular Diagnostics: A Revolution in Progress.”

“Based on the reported data and work in progress, I believe the ‘liquid biopsy’ will revolutionize cancer diagnostics, not only before a patient begins therapy but also following patient responses to therapy,” said Mitchell, the paper’s corresponding author and professor of Pathology, Microbiology and Immunology.

Read full article here.

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Immunotherapy: Houston holds promise for some cancer patients

Author: Haley Hernandez, Reporter

HOUSTON –

Looking ahead to the health trends of 2015, one that’s gaining attention comes from Houston. It’s called immunotherapy.

It’s been around for more than a decade, but in research terms that’s still juvenile. However, this therapy is far from child’s play, it’s showing significant promise in curing some people’s cancer.

The person behind the whole idea is a Houston researcher, Dr. Jim Allison

It was once seen as a controversial method, sometimes labeled as “too simple,” Allison said, but today Houston’s M.D. Anderson Cancer Center considers it a promising treatment on the path to cure cancer.

M.D. Anderson President Ronald DePinho was quoted on the center’s website saying, “Jim Allison’s discoveries led to the first drug ever to improve the survival rate of patients with metastatic melanoma – by itself a remarkable achievement. His insights into the basic biology of immune system T-cells will be broadly applicable to a variety of cancers and his gifted scientific leadership is essential to the definitive progress that must be made against these diseases.”

Read full article here.

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 DASH Diet Named Best Overall Diet

By Amy Orciari Herman
Edited by
– David G. Fairchild, MD, MPH, and
– Lorenzo Di Francesco, MD, FACP, FHM

Date: Wed, 7 Jan 2015 07:26:15 -0500 (EST)

From: Physician’s First Watch <FirstWatch@jwatch.org>

The Dietary Approaches to Stop Hypertension (DASH) diet has earned the top spot in U.S. News & World Report’s 2015 Best Diet rankings, earning 4.1 out of 5 stars for best overall diet. To do well in this category, a regimen “had to be relatively easy to follow, nutritious, safe, effective for weight loss and protective against diabetes and heart disease.”

Close runners-up include the TLC Diet, the Mayo Clinic Diet, Weight Watchers, and the Mediterranean Diet. Coming in 34th (and last) place is the Paleo Diet.

Diets were also ranked in seven sub-categories. Weight Watchers earned the top slot for Best Weight-Loss Diet, the Biggest Loser Diet and DASH tied for first for Best Diabetes Diet, and the Ornish Diet won for Best Heart-Healthy Diet.

Link(s):

U.S. News and World Report rankings (Free) http://click.jwatch.org/cts/click?q=227%3B68120847%3BSF896W9WRkFpDcc1c6hHkx1k4sInqPqQnoT43Nsnt2E%3D

Background: NEJM Journal Watch Cardiology coverage of the DASH diet as part of the AHA/ACC 2013 guidelines for a heart-healthy lifestyle (Free)http://click.jwatch.org/cts/click?q=227%3B68120847%3BSF896W9WRkFpDcc1c6hHkwRpVatDGEe8noT43Nsnt2E%3D

Background: NEJM Journal Watch Women’s Health coverage of the TLC diet (Your NEJM Journal Watch registration required) http://click.jwatch.org/cts/click?q=227%3B68120847%3BSF896W9WRkFpDcc1c6hHk1nYOmN4S1VTnoT43Nsnt2E%3D

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Higher Whole Grain Intake Linked to Lower Mortality

By Jenni Whalen
Edited by
– David G. Fairchild, MD, MPH

Higher intake of whole grains is associated with reduced overall mortality and especially cardiovascular mortality, according to a JAMA Internal Medicine study.

Researchers followed approximately 74,000 women from the Nurses’ Health Study from 1984 to 2010, and nearly 44,000 men from the Health Professionals Follow-Up Study from 1986 to 2010. Participants were free of cancer and cardiovascular disease at baseline; they completed dietary questionnaires every 2 to 4 years.

After adjustment for confounders (e.g., age, smoking, BMI), higher whole grain intake was associated with lower total mortality (hazard ratio for highest vs. lowest quintile of whole-grain consumption, 0.91). In particular, cardiovascular mortality was reduced — especially with high intake of brans (HR, 0.80). Whole grain intake did not reduce cancer mortality.

The authors conclude: “These findings further support current dietary guidelines that recommend increasing whole grain consumption to facilitate primary and secondary prevention of chronic diseases and also provide promising evidence that suggests … benefits toward extended life expectancy.”

Link(s):

JAMA Internal Medicine article (Free abstract) http://click.jwatch.org/cts/click?q=227%3B68120292%3BEajcC8433E4nuzeIQBcwK2yPeshikEj6bHM5i45QzVc%3D

Background: Physician’s First Watch coverage of whole grains and diabetes risk (Free) http://click.jwatch.org/cts/click?q=227%3B68120292%3BEajcC8433E4nuzeIQBcwK5a49Jyvn3Q4bHM5i45QzVc%3D

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Good news for future biopsies. — Stan

Check out the reference below (a video)

<http://www.news4jax.com/news/new-prostate-cancer-test/29296862>http://www.news4jax.com/news/new-prostate-cancer-test/29296862

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Massachusetts-Based Biotech Firm Develops Prostate Cancer Vaccine.

WBZ-TV Boston (10/22, Marshall) reports on its website that a Newton, Massachusetts-based biotech company, Advantagene has developed a prostate cancer vaccine called ProstAtak, which is “designed to prevent cancer from coming back.” Dr. Estuardo Aguilar, the CEO of Advantagene said that “It’s like putting the tools into the tumor so that the body itself can create a vaccine against that specific tumor.” The article notes that the early studies of the drug showed that the chances of “recurrence” reduced by 75 percent. The study is now recruiting patients for a larger clinical trial and will likely seek FDA approval within next few years, the article reports.

If you are interested in the clinical trial, check out the web site below.

http://boston.cbslocal.com/2014/10/22/newton-company-develops-prostate-cancer-vaccine/

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WRNMMC Us TOO, Inc.
A PROSTATE CANCER SUPPORT GROUP  SPONSORED BY WALTER REED NATIONAL MILITARY MEDICAL CENTER
NEWSLETTER
VOLUME 23 NUMBER 3 AUGUST 2014
PROSTATE-SPECIFIC ISSUES

Six Months Hormone Therapy Plus Radiation Therapy Improves Prostate Cancer Survival.

A pill that blocks male hormone activity can improve survival and delay the need for chemotherapy in men with advanced prostate cancer, a new clinical trial has found. The trial involved more than 1,700 men located across the globe. Researchers randomly assigned 872 to receive enzalutamide, and the other 845 to take a placebo. Men who took a daily dose of the drug enzalutamide started chemotherapy nearly a year and a half later than men who received a placebo, even though their prostate cancer had spread to other parts of their bodies, researchers said.

The oral drug also improved survival by nearly a third compared with placebo. The benefits of enzalutamide were so great that the independent committee overseeing the clinical trial ended it early so the men receiving placebo could be offered the drug, Beer said.

Enzalutamide blocks the ability of male hormones, also called androgens, to bind with prostate cancer cells and fuel their growth. The drug is already approved by the U.S. Food and Drug Administration for prostate cancer patients who have had chemotherapy, based on its ability to prolong their survival. Researchers decided to see if enzalutamide could help men prior to chemotherapy, since it is an easy-to-take pill with fewer side effects than standard chemo.

One year into the study, two-thirds of enzalutamide patients showed no progression in their prostate cancer, compared with just 14 percent of patients in the placebo group. Overall, the pill reduced the risk of death by 29 percent, researchers reported. Seventy- two percent of patients in the enzalutamide group were alive when the trial was halted. In the placebo group, 63 percent were alive at the end of the trial.

The medication also caused prostate-specific antigen levels to decline by at least half in 78 percent of the men assigned enzalutamide, compared with 3 percent of placebo patients. Doctors use high PSA levels to diagnose prostate cancer.

One observer said enzalutamide is an incredibly well-tolerated drug that has some minor side effects. Side effects included high blood pressure, fatigue, back pain, constipation and joint pain. He also noted anything that can delay the onset of chemotherapy is a plus for patients. A number of patients are just not ready to pull the trigger on something as toxic as chemotherapy, if you can put it off.

It reportedly is at least as good as and possibly has a greater magnitude in reduction of risk of death than abiraterone. Both drugs are expensive, costing $8,000 to $9,000 a month. FDA approval for using enzalutamide prior to chemotherapy could come fairly quickly. (Source: HealthDay News, June 2, 2014, via MedlinePlus) Prostate Cancer Tests Underestimate Disease Severity in Half of Cases. This study in the United Kingdom involved 847 men with prostate cancer: 209 out of the 415 who were initially told their cancer was slow-growing were found to have a more aggressive form of the disease. And for almost a third of the 415 men, it had spread beyond the prostate. Scientists are calling for better tests to define the nature of the cancer. Prostate cancer is the most common male cancer in the UK. There are 41,700 new cases diagnosed and 10,800 deaths each 6 year.

For this study, scientists at the University of Cambridge graded the men’s cancer before and after they had surgery, between 2007 and 2011. Shaw, et al., the University of Cambridge, found there were a “surprising” number of men who were not diagnosed appropriately the first time around. The researchers said the study was “very important” for British men as cohorts abroad were not always comparable to the type of prostate cancer in the UK.

At the moment, men with low-grade, early stage cancers are offered the choice of an operation, to remove the prostate, or active surveillance, where doctors perform regular blood tests and examinations. Dr. Shaw said if men opted for active surveillance, 30% of them would be likely to need “radical treatment”, such as surgery and radiotherapy, five years later. But he added there was potential for bias in the study, as there might have been a subtlety in the advice given to men in the clinic that hinted their cancer was more severe, which could have been why they opted for surgery. So the study was not necessarily representative of those

men who opted for active surveillance, he said. Shaw said a template biopsy, which looks at more tissue samples than the usual prostate biopsy, should be included. More samples may give a clearer picture of the extent of the disease.

He also said MRI scans should be improved to identify how aggressive the prostate cancer was from the outset. An observer agreed that this was a very good and thoughtful study, but he said the study had limitations as the definitions of “significant” cancer were uncertain. Dr Iain Frame, director of research at Prostate Cancer UK said: “Accurate prostate cancer diagnosis continues to be one of the biggest challenges facing the disease today. “The results of this study highlight yet again that existing tests cannot provide a precise picture of the aggressiveness

of a man’s cancer, often leaving men and their doctors to make difficult decisions about treatment without all the facts.” He said until tests improved, it was important men talked to their doctors about the pros and cons of each treatment. (Source: BBC Health News, April 10, 2014)

MRI FOR PROSTATE BIOPSIES INCREASES ODDS OF FINDING AGGRESSIVE TUMORS. Prostate biopsies performed using magnetic resonance imaging (MRI) are more likely to find aggressive tumors than those that rely on ultrasound, suggests a new study at Washington University School of Medicine in St. Louis.

Prostate biopsies often are recommended when blood levels of prostate-specific antigen (PSA) rise above 4.0 ng/ml. Typically, the procedures are performed using ultrasound to guide the placement of biopsy needles into the prostate. But ultrasound is not sensitive enough to visualize suspicious areas that might indicate cancer. So, urologists randomly distribute needles into the prostate to withdraw tissue samples for analysis.

“Biopsies performed under ultrasound guidance are very much hit or miss,” said prostate cancer expert Gerald Andriole, MD, chief of urology at Washington University School of Medicine and Barnes-Jewish Hospital. “If a biopsy is negative, there’s a significant chance that it missed a cancer, and if it’s positive, there’s a tendency to treat the cancer aggressively due to concerns that the biopsy missed an aggressive component of the cancer. This leads to many men receiving excessive treatment.”

Each year in the United States, about 1 million men undergo prostate biopsies, but only about 20 to 25 percent are positive. The procedure can be painful and comes with a risk of bleeding and infection.

In recent years leading urologists have been investigating whether targeted biopsies performed using MRI to visualize suspicious areas of the prostate are more likely to be accurate. Washington University is the only center in the St. Louis region where targeted prostate biopsies are performed using MRI guidance.

In the new study, Andriole evaluated his experience with MRI-guided prostate biopsies in 70 men who had the procedure at some point from December 2010 to July 2013. Their average age was 65, and their PSA scores averaged just above 8.0 ng/ml.

The biopsies were performed after results of MRI scans of the prostate were available. For each biopsy, he took multiple tissue samples in areas of the prostate that looked suspicious for cancer as well as in non-suspicious areas where cancers may have been too small to visualize with MRI.

The analysis showed that biopsies targeted to suspicious areas of the prostate were nearly three times more likely to find cancer than those targeted to non-suspicious areas. Further, biopsies targeted to suspicious areas were four times more likely to detect aggressive tumors that warranted treatment. Such tumors have a Gleason score of 7 or more. The Gleason scoring system measures tumor aggressiveness based on biopsy results and can range from 1-10, with 10 being the most aggressive.

MRI is not perfect, Andriole noted. In this study, it accurately predicted a positive biopsy 62 percent of the time. For men with elevated PSAs, biopsies targeted to suspicious areas with MRIs missed about 7 percent of aggressive tumors. By comparison, ultrasound biopsies typically miss up to 20 percent of aggressive cancers.

But as MRI technology improves, Andriole thinks prostate cancer screening eventually could be like mammography screening for breast cancer. If a mammogram is negative, there’s no need for a biopsy, but if it’s positive, a targeted biopsy is performed to confirm or rule out cancer. “We hope to get there with prostate cancer,” said Andriole, the Robert Killian Royce, MD, Distinguished Professor of Urologic Surgery. “In the future, if a man has an elevated PSA, we’d like to do an MRI and be so confident in the technology that we’d only do a targeted biopsy if the MRI were positive. We’re not there yet, but that’s the goal.” (Source: Siteman Cancer Center, Washington University School of Medicine, May 20, 2014)

Some Prostate Cancer Patients Might Safely Delay Hormonal Therapy. In this new study, researchers found that it was safe to delay hormone-depleting therapy in men with rising PSA levels who did not experience symptoms nor have evidence of a tumor. Hormone-depletion therapy is a common treatment for prostate cancer, but one

that also carries side effects for men such as sexual dysfunction and fatigue. However, this new study suggests that in certain cases the treatment can be delayed­—boosting the patient’s quality of life. One expert applauded the study. “In view of the cost and potential side effects that are associated with hormonal therapy, this is an

important study that supports the notion that we don’t have to jump on early hormonal therapy if PSA is showing signs of recurrence,” said Dr. Ash Tewari, chair of urology at the Icahn School of Medicine at Mount Sinai, in New York City. “This study is also a great example of how less-aggressive treatment can sometimes offer patients optimal outcomes while sparing them from side effects that impair their quality of life,” he added.

Natural hormones such as testosterone are known to be associated with the growth of prostate tumors. So, one common treatment, called androgen deprivation therapy, involves reducing a patient’s levels of these hormones. However, experts note that the therapy also has side effects, including sexual dysfunction, weakening bones, hot flashes, fatigue, decreased mental sharpness, depression and loss of muscle mass, among others.

But what if the therapy could be at least delayed, even if a patient’s PSA levels are rising? The new study found that, in certain cases, delaying hormonal therapy in this scenario is possible. In the study, the researchers looked at data on more than 14,000 patients. Of these, just over 2,000 saw their PSA levels begin to climb again after prostate surgery or radiation therapy.

These “PSA relapse” patients were divided into two groups: those who received hormone therapy immediately and those who deferred their hormone therapy until later. The “immediate” group received hormone-depleting therapy within three months of their PSA relapse. The “deferred” group did not receive it until they developed a tumor or symptoms.

Men in the “deferred” group also received hormonal therapy if their PSA level doubled in a short period of time. Overall, the average time from initial treatment to PSA relapse was a little more than 2 years, the researchers said. After experiencing a relapse, the men were followed for an average of almost 3.5 years.

Waiting longer to begin hormone therapy did not have a significant effect on men’s long-term survival, the researchers reported. The estimated five-year survival for the “immediate” treatment group was about 85 percent, compared to just over 87 percent for the “deferred” group—not a significant difference. The researchers concluded there was no significant benefit to starting hormone therapy right away after a PSA relapse. Postponing treatment could, however, reduce the side effects and costs linked with hormone therapy. Waiting to begin treatment could give men two or more years of life without some of the common and distressing symptoms tied to the therapy, the researchers suggested.

According to the researchers, rising PSA levels trigger a lot of anxiety, and many men want to start treatment as soon as possible. These findings suggest that there may be no need to rush to androgen deprivation therapy. If the results are confirmed in randomized trials, patients 9 could feel more comfortable waiting until they develop symptoms or signs of cancer that are seen on a scan, before initiating therapy. However, research presented at medical meetings is typically considered preliminary until published in a peer-reviewed journal, and the researchers agreed that more research will be necessary.

(Source: American Society of Clinical Oncologists news release, May 14, 2014, and HealthDay News, May 14, 2014)

New Approach May Boost Survival From Advanced Prostate Cancer.

Adding generic docetaxel to standard hormonal treatment seems to have benefit. Adding the chemotherapy drug docetaxel to standard hormone-depleting therapy may extend the lives of men with advanced prostate cancer, a new study finds. Hormone therapy has been a standard treatment for prostate cancer since the 1950s. According to the researchers, this is the first study to identify a strategy that prolongs survival in newly diagnosed metastatic prostate cancer. The benefit is substantial and warrants this being a new standard treatment for men who have extensive disease and are fit for chemotherapy.

One expert not connected to the new trial agreed that these data are practice-changing and help us further improve the care we give to patients with prostate cancer. He further believes the study will also help to better understand the biology of the most aggressive and lethal prostate cancers so we can design new clinical trials to further improve the outcomes of men with this devastating disease.

Prostate cancer is often spurred on by hormones such as testosterone, so hormone-depleting therapy is the standard initial treatment for these “hormone-sensitive” tumors. The treatment is initially effective, but the disease eventually becomes resistant to the therapy in most patients. Chemotherapy is typically started only after the disease progresses despite hormone therapy, experts note.

In this U.S. National Cancer Institute-led study, 790 men newly diagnosed with advanced hormone-sensitive prostate cancer were divided into two groups. One group received hormone therapy alone, while the other group got hormone therapy plus docetaxel for 18 weeks.

After a median follow-up of more than two years, there were 136 deaths in the hormone therapy-only group, and 101 deaths in the hormone therapy-plus-docetaxel group. Median survival was 44 months in the hormone therapy group and 57.6 months in the hormone therapy/docetaxel group, the researchers reported.

Among men whose prostate cancer had spread to major organs or bones, median survival was 32.2 months in the hormone therapy group and 49.2 months in the hormone therapy/docetaxel group.

The use of docetaxel also delayed cancer progression, the study found. Median time to progression after treatment was 19.8 months in the hormone therapy group and 32.7 months in the hormone therapy/docetaxel group.10

“These results demonstrate how we can use ‘old tools’ in new, more powerful ways to improve and extend patients’ lives,” ASCO President Dr. Clifford Hudis said in the ASCO news release.

“This study is also a powerful testimony to the importance of National Cancer Institute-led research, as both of these drugs are available in generic form today and this research might have otherwise not been pursued,” he added.

Experts caution that studies presented at medical meetings should be considered preliminary until published in a peer-reviewed journal. (Source: American Society of Clinical Oncology, news release, June 1, 2014; and HealthDay News, June 1, 2014)

Varying Cost of Prostate Cancer Surgery. For an uninsured man with prostate cancer, the price of surgery could range from $10,000 to $135,000, depending on the hospital, a U.S. study finds. What’s more, that wide range in charges — a 13-fold difference — has nothing to do with quality, researchers said. “Consumers are used to higher prices meaning higher quality.

But that’s not true in medicine,” said Dr. Bradley Erickson, the senior researcher on the study. “Prices are not attached to any kind of quality information.”

What does determine hospital charges for prostate cancer surgery? “We really don’t know,” said Erickson, an assistant professor of urology at the University of Iowa in Iowa City.

What’s clear, Erickson said, is that a man with no health insurance — or insurance with high copays — would have a tough time “shopping” for the best hospital for prostate cancer surgery.

For the study, recently published in the journal Urology, one of Erickson’s colleagues pretended to be an uninsured man in need of prostate cancer surgery. He called 100 American hospitals, following the same “script” each time: He was an otherwise healthy man with the means to pay out-of-pocket, and he wanted an estimate of the total charge for surgery — hospital and surgeon fees included.

Thirty percent of hospitals said they couldn’t offer an estimate. Among the rest, the price ranged from $10,100 to $135,000 — though only three hospitals were willing to put a quote in writing. The average price was almost $35,000, more than twice the Medicare reimbursement, the researchers said. Geography mattered. Hospitals in the Northeast quoted higher prices, on average, than hospitals in the South — about $40,800 versus $30,300.

But in other ways, there was little rhyme or reason. Big-city hospitals, for example, charged no more than those in small cities, on average. And there was no relationship between hospital charges and their ranking by U.S. News and World Report, which publishes a list of the nation’s “best” hospitals.

Experts who reviewed the study weren’t surprised. Other U.S. studies have shown wideranging prices for health care, said Dr. Ezekiel Emanuel, chair of medical ethics and health policy at the University of Pennsylvania in Philadelphia. He pointed to a study last year — by the same researchers — showing that the price of hip-replacement surgeries at U.S. hospitals ranged from roughly $11,000 to $126,000.11

There are some reasons that hospital charges could legitimately vary. For example, their costs for equipment differ to some degree.

“But mostly, it’s a mystery,” Erickson said. “I don’t think the hospitals even know why they charge what they charge.”

The American Hospital Association declined a request to comment on the study. The “good news,” Erickson said, is that 70 percent of hospitals did provide a price estimate, which is a larger response than some past studies have seen.

The not-so-good news: The “patient” here was a researcher who could ask savvy questions. Even so, a typical inquiry involved talking to four or five people, for up to 69 minutes, Erickson said. It’s not clear how a real patient would fare on the phone, he added. And even if you get price information, “that’s only half the story,” Emanuel said. “You also need to know if you’re getting a Yugo or a Mercedes.”

Uwe Reinhardt, a health care economics expert at Princeton University in New Jersey, agreed.

“Telling Americans to ‘shop’ for health care is like pushing someone into Macy’s blindfolded, then saying, ‘OK, go shopping,'” Reinhardt said. Not only does price have little relation to quality, he said, but the estimates hospitals give are just that. The actual charges could be greater.

The study did uncover one way for patients to get a financial break. One-third of hospitals said they would give a discount if the “patient” paid up front. On average, that meant one-third off the quoted price—but some hospitals went as high as 80 percent.

For patients who can pay in advance, Erickson said, it might be worthwhile to call different hospitals and ask about a discount. To Reinhardt, the findings spotlight a convoluted system.

“This study points up the sheer absurdity of our health care system, which most of the public isn’t even aware of,” he said. (Source: Urology, March 2014, via HealthDay News, June 19, 2014)

Diet and Lifestyle Affect Prostate Cancer Risk. Eating high-fiber carbs, drinking less milk, avoiding diabetes and heart risk factors may help cut prostate cancer risk, according to a trio of new studies.

A diet rich in complex carbohydrates and lower in protein and fat is associated with a 60 percent to 70 percent reduced risk of prostate cancer, according to Vidal, et al., a Duke University School of Medicine, Durham, N.C. In addition, a fiber-filled diet reduced the risk of aggressive prostate cancer by 70 percent to 80 percent, according to Vidal. “Good carbs, high-quality carbs, and high fiber are definitely protective against prostate cancer,” Vidal said. The two other studies found that:

• Drinking lots of milk could increase a man’s risk of advanced prostate cancer.

• Men suffering from two or more health problems linked to metabolic syndrome also have an increased risk of aggressive prostate cancer.

Metabolic syndrome is a group of risk factors that increase a person’s risk of heart disease, diabetes and stroke. They include obesity, high blood pressure, elevated blood sugar levels, elevated levels of triglycerides (blood fats) and reduced levels of “good” HDL cholesterol.

“When men have two metabolic syndrome components, their risk of high-grade prostate cancer goes up almost 35 percent,” Vidal said. “With three to four components, their risk goes to almost 94 percent increased.”

These studies shed more light on connections between diet, lifestyle and prostate cancer that up to now have been “tenuous,” said Dr. Durado Brooks, director of prostate and colorectal cancers for the American Cancer Society. “We don’t have as good evidence regarding a link between diet and prostate cancer as we do with colorectal cancer or breast cancer, and there has been some conflicting data in previous studies,” Brooks said.

The first study focused on a group of 430 veterans at the VA Hospital in Durham, N.C., including 156 men with confirmed prostate cancer. Researchers had the men fill out questionnaires to track the amount of carbohydrates, protein and fat in their daily diets.

The researchers found that when men received more of their energy from carbohydrates rather than protein or fat, their risk of prostate cancer declined. High fiber intake also appeared to reduce prostate cancer risk. Additionally, they found that foods like simple carbohydrates that cause blood sugar to spike appear to increase prostate cancer risk in black men.

That finding, along with the results of the metabolic syndrome study, seem to indicate there could be an as-yet-unknown connection between blood sugar levels and male hormones like testosterone that increase prostate cancer risk, Vidal said.

In the second study, doctors reviewed the consumption of dairy products among nearly 3,000 people, including almost 1,900 men with either localized or advanced prostate cancer. The investigators found that drinking milk was associated with advanced prostate cancer. However, total dairy consumption was not related to prostate cancer risk, nor were consumption of yogurt, ice cream and cheese.

The analysis also found that men with low overall calcium intake were at greater risk of prostate cancer when they ate more dairy products, compared with men with average or high levels of calcium in their diet. The findings suggest that although calcium intake likely contributes to an increased risk of prostate cancer, “additional components in dairy may contribute to prostate cancer development,” the authors concluded.

The final study focused on the effects of metabolic syndrome on a man’s chances of prostate cancer, with researchers reviewing data gathered for almost 6,500 men in an unrelated clinical  trial.

Researchers found that men with multiple metabolic syndrome risk factors had a progressively increased risk of prostate cancer.

“The more metabolic syndrome components, the more risk for high-grade prostate cancer,” Vidal said.

The findings are in keeping with previous studies linking one of those risk factors, obesity, to a higher risk of aggressive prostate cancer, Brooks said.

“The question is whether because of their obesity these men are less likely to have their cancer identified and biopsied at an earlier stage,” he said. “These researchers feel there’s more than just delayed diagnosis, that there’s something about these risk factors that contributes to prostate cancer.”

Findings from these studies were scheduled for presentation at the American Urological Association’s annual meeting in Orlando, Fla. Results from studies presented at meetings are generally considered preliminary until they’ve been published in a peer-reviewed journal. (Source: Presentations, American Urological Association annual meeting, Orlando, Fla., May 20, 2014, via HealthDay News and MedlinePlus, June 6, 2014)

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Controlling Frequent Urination or Overactive Bladder Syndrome

There is a very effective technique for controlling frequent urination or Overactive Bladder Syndrome which I had gotten from an old Johns Hopkins White Paper on prostate disorders.  While we are all a bit different and the problem can stem from different issues, most should find this very effective in greatly expanding the time between trips to the head.

The urologists tell us that as we age, our bladders lose their elasticity and we lose capacity.  That may be, but it isn’t a function of the aging process per se.  We bring it on ourselves!  Or as Pogo used to say, “We have met the enemy and it is us.”  A big part of the problem is that we tend to void at the first urge to urinate, particularly now that most of us are retired and have more time on our hands and fewer job pressures.  So we put little demand on our bladders to maintain capacity or even expand it.  Over time the bladder loses both capacity and elasticity, exacerbating the problem.  And before too long, we get panicky at the first indication of an urge to pee and immediately start to traverse and search to find a men’s room.

Compare this effect to the NiCd battery in your cordless phone or electric razor.  When the charge gets low, the system tells you to recharge it, even though there is still some residual charge (think capacity) left.  But the battery has “memory” and remembers the new base threshold.  So it loses a small amount of capacity on each recharge, and after a year or so when it holds only a day or two of charge, you shell out $15 or so for a new battery.  But we’re not into buying new bladders yet.  I might add that if your battery system allows you to get the charge to zero before recharging, you can get 4-5 years out a NiCd battery.  Don’t short it though.  It’ll blow up on you.

So here’s the technique whereby you can retrain your bladder and substantially increase its elasticity and capacity:

To start off, for about a week, when you have the urge to urinate, hold it for about five minutes before voiding.  Then gradually expand the time to 10 minutes and more.  Before long you will find that the urge subsides completely, only to return 30 minutes to an hour later.  Keep on pushing the envelope.  You are doing two things — expanding your bladder’s capacity and training yourself to not react at the first urge.

Now in order to build up your confidence in being able to hold it in, you also need to be doing Kegel exercises if you aren’t doing so already.  Check out <http://www.kegelexercisesformen.com/kegel_exercises_for_men.html> for starters.  And there are a number of other articles on Google.  Kegels also help to improve sexual performance, so there is some spin-off here.

This is not a fun process, but the rewards can be dramatic if you keep at it.  You will find that significant improvement in daytime capacity is relatively easy.  But it can be a lot more difficult to pull this off at night.  It’s just too easy to conclude that you’d rather get up and void than to lay there holding it and maybe not being able to get back to sleep.  But it’s a matter of ” No pain, no gain.”  After you have done your Kegels for a while and built up your confidence and your daytime capacity, try rolling over and holding it in.  Before long you will find yourself dosing off again for a half hour or hour.  Of course it helps to stop drinking liquids after about 7:30 in the evening.  And for those who like to belt down a nightcap before turning in, you might get to sleep faster, but you are creating a couple of problems — you are disrupting the natural sleep pattern and you will find yourself waking up sooner, and you have more liquid to void since alcohol tends to dehydrate the system.

This has been working well for me, and I’m still pushing the envelope, particularly at night.  Give it a try if you have the problem, and let us know how you are doing with it.  Or if you have found other routes to success, let us know about them.

Stan Bacon

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Researchers discover gene that can predict aggressive prostate cancer at diagnosis

GS7 is Gleason score 7, the apparent breakpoint between less severe and potentially aggressive cancer. Anyone who has or will be diagnosed with a Gleason 7 should pursue genetic testing to clarify the aggressiveness of the cancer. — Stan Bacon

Study identified a genetic variant near the KLK3 gene that could stratify GS7 prostate cancer patients

MD Anderson News Release 10/02/14

Researchers at The University of Texas MD Anderson Cancer Center have identified a biomarker living next door to the KLK3 gene that can predict which GS7 prostate cancer patients will have a more aggressive form of cancer.

The results reported in the journal of Clinical Cancer Research, a publication of the American Association of Cancer Research, indicate the KLK3 gene – a gene on chromosome 19 responsible for encoding the prostate-specific antigen (PSA) – is not only associated with prostate cancer aggression, but a single nucleotide polymorphism (SNP) on it is more apparent in cancer patients with GS7.

Researchers have linked Gleason score, an important predictor of prostate cancer outcomes, to several clinical end points, including clinical stage, cancer aggression and survival. There has been much research associated with prostate cancer outcomes as well as GS7 prostate cancers, which is an intermediate grade of cancer accounting for 30 to 40 percent of all prostate cancers.

“This is the first report that I am aware of that indicates a genetic variant can stratify GS7 prostate cancer patients,” said Jian Gu, Ph.D., associate professor at MD Anderson, and a key investigator on the study. “This is important because this group with heterogeneous prognosis is difficult to predict and there are no reliable biomarkers to stratify this group.”

In this study, researchers investigated inherited genetic variants to see if there would be any promising biomarkers for prostate cancer patients.  The investigators studied the genetic makeup of 72 SNPs identified from the genome-wide association studies (GWAS) in 1,827 prostate cancer patients. They analyzed associations of these SNPs with disease aggression, comparing them in clinically defined high and low aggressive cases. They found a SNP on the KLK3 gene that can predict an aggressive form of GS7 disease.

“Treatment options for the GS7 disease are controversial because the burden of combined treatment modalities may outweigh the potential benefit in some patients,” said Xifeng Wu, M.D., Ph.D., professor and chair of Epidemiology, and lead investigator on the study. “It is critical that we develop personalized treatments based on additional biomarkers to stratify GS7 prostate cancers. Additional biomarkers may help us achieve personalized clinical management of low and intermediate risk prostate cancer patients.”

Xifeng Wu, M.D., Ph.D.

Wu also said her team are expanding the study and taking a pathway-based approach to systemically investigate genetic variants in microRNA regulatory pathways as biomarkers for the prognosis of prostate cancer patients.  “We are also working on circulating biomarkers.  Eventually, we will incorporate all biomarkers, epidemiological and clinical variants into nomograms to best predict the prognosis of prostate cancer patients at diagnosis.”

Other MD Anderson co-authors include Yonggang He, M.D., Ph.D. and Sara Strom, Ph.D., of Epidemiology; Christopher Logothetis, M.D. and Jeri Kim, M.D., of Genitourinary Medical Oncology.

The study was funded by the National Cancer Institute (CA140388) and MD Anderson Cancer Center institutional support for the Prostate Cancer Moon Shots Program and the Center for Translational and Public Health Genomics.

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Is the PSA Test Worth It? Major Study Is Inconclusive

While the prostate screen does seem to save lives, worries about overdiagnosis remain, experts say. Click here for article.

By Robert Preidt
HealthDay Reporter

August 6, 2014 (HealthDay News) — The value of the PSA test to screen men for prostate cancer has long been debated, and a new study of 162,000 men may not resolve the issue.

The European study, reported Aug. 6 in The Lancet, finds that widespread use of prostate-specific antigen (PSA) blood tests does reduce deaths from the disease by about one-fifth.

However, due to lingering doubts about whether the benefits of PSA screening outweigh the risks, the study’s authors still recommend against routine use of the test at this time.

“PSA screening delivers a substantial reduction in prostate cancer deaths, similar or greater than that reported in screening for breast cancer,” study lead author Fritz Schroder, of the Erasmus University Medical Center in the Netherlands, said in a journal news release.

“However, overdiagnosis occurs in roughly 40 percent of cases detected by screening resulting in a high risk of overtreatment and common side effects such as incontinence and impotence,” he added.

In the context of prostate cancer, “overdiagnosis” means that some men may receive a diagnosis of prostate cancer from their PSA test, but the tumor may be so slow-growing that it might not pose a major threat to their health. However, the positive test result may still cause many patients to opt for treatments that entail side effects.

The new study included more than 162,000 men ages 50 to 74 in eight European countries. The men were randomly selected to have PSA screening every two or four years, or no PSA screening.

Compared to men who weren’t screened, death rates among men in the screening group were 15 percent lower after nine years, 22 percent lower after 11 years, and 21 percent lower after 13 years, according to the study.

Schroder’s team noted that not all men selected for screening went for the tests. After 13 years, those who were actually screened were 27 percent less likely to die of prostate cancer than those who were not screened.

The study also found that, 13 years into the study, 781 men needed to be invited for screening to prevent one prostate cancer death.

Based on the study findings, Schroder believes that the “time for population-based screening has not arrived. Further research is urgently needed on ways to reduce overdiagnosis preferably by avoiding unnecessary biopsy procedures, and reducing the very large number of men who must be screened, biopsied, and treated to help only a few patients.”

Two experts in the United States agreed with Schroder’s assessment.

The study “reinforces urologists’ concern about overdiagnosis and overtreatment of prostate cancer using PSA screening alone,” said Dr. Art Rastinehad, director of interventional urologic oncology at North Shore-LIJ’s Arthur Smith Institute for Urology in New Hyde Park, N.Y.

But he added that evolving diagnostic technologies “may allay these understandable concerns. Indeed, The Lancet study authors proposed that new screening tools may hold the key to better selecting patients for biopsy and subsequent treatment.”

Dr. Arul Chinnaiyan is professor of urology at the University of Michigan and director of the Michigan Center for Translational Pathology in Ann Arbor. He agreed with Rastinehad that the study “emphasizes the need for better diagnostic biomarkers or imaging technologies to detect aggressive forms of prostate cancer in a specific fashion.”

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Date: Wed, 27 Aug 2014 10:03:44 +0000 (GMT)
From: Johns Hopkins Health Alerts

A Look at the UPDATED Partin Tables

Prostate cancer experts at Johns Hopkins have developed an updated version of the Partin Tables, a tool to help men diagnosed with prostate cancer and their physicians better assess their chance of a surgical cure. The refined tool, based on a study of more than 5,600 men treated at The Johns Hopkins Hospital from 2006 to 2011, was published in the British Journal of Urology International.

“The first thing most men want to know when they learn they have prostate cancer is their prognosis and whether they will be cured,” says Alan W. Partin, M.D., Ph.D., Professor and Director of the Brady Urological Institute at Johns Hopkins and creator of the Partin Tables.

The Partin Tables are a statistical model to show the probability that the prostate cancer is confined to the prostate and therefore is likely to be cured with surgery. The model is based on a patient’s prostate specific antigen (PSA) level, Gleason score (a number from 2 to 10 that estimates the aggressiveness of tumors removed during a biopsy based on their appearance under a microscope) and clinical stage, which is the extent to which a tumor can be felt during a digital rectal exam.

Data for the Partin Tables, first published in 1993, have been based on the outcomes for more than 20,000 men who underwent prostate removal (known as radical prostatectomy surgery) at Johns Hopkins over the past three decades. This latest iteration represents the third update of the data.

The newly revised Partin Tables show that certain categories of men who were previously not thought to have a good prognosis actually could be cured with surgery. That’s because the researchers now have a better understanding of intermediate risk and see that more men now fall into that category, instead of the higher-risk group.

For example, men with a biopsy Gleason score of 8 and above previously were not thought to be good candidates for surgery because of the likelihood that the prostate cancer had spread. The new Partin Tables data show a higher probability of a cure with surgery even if a man’s Gleason score is 8.

Gleason scores of 9 and 10 are still considered high risk, indicating that the prostate cancer likely has spread. The researchers also found that having a PSA level of 10 and above was a better cut-off for predicting the spread of disease compared with lower levels.

To access the updated Partin Tables, click link. By inputting your PSA, the Gleason score, and the clinical stage results and clicking on “find results,” you can see the percentage chance that the cancer is confined to the prostate, has migrated to the edge of the gland, has invaded the seminal vesicles, or has spread to the lymph nodes.

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PHYSICIAN’S FIRST WATCH for August 7, 2014
David G. Fairchild, MD, MPH, Editor-in-Chief

 Prophylactic Aspirin Use Associated with Reduced Cancer Risk

 By Kelly Young
Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM

Using daily low-dose aspirin for a minimum of 5 years appears to have more benefits than harms in terms of cancer prevention, according to a review in the Annals of Oncology.

 The review found reduced cancer incidence and mortality at doses between 75 and 325 mg per day, starting between ages 50 and 65, with longer duration of use appearing to confer the greatest benefits. Men and women at average risk who took aspirin for a decade could expect relative reductions of 9% and 7%, respectively, in the rate of cancer, myocardial infarction, or stroke over 15 years.

The researchers found substantial benefit in terms of colorectal, esophageal, and gastric cancer incidence and mortality. Reductions in breast, lung, and prostate cancers were more modest.

As expected, aspirin use was associated with increased risk for bleeding events, but the cancer-prevention benefits outweighed this risk.

 Link(s):

 Annals of Oncology article (Free)

 Background: Physician’s First Watch coverage of aspirin and pancreatic cancer (Free)

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MR Fusion Guided Prostate Biopsy

The biopsies available to date have been pretty much hit or miss with a fair chance of missing cores in key cancerous areas. Now there is the MR Fusion Guided Prostate Biopsy that identifies areas of particular concern and enables the core sampling to target those areas. A variety of sites describe this process. One is at <http://www.interventionalurology.com/mr-trus-fusion-guided-prostate-biopsy/>. Check the video at the bottom of the site. Once played there are displayed a number of others depicting differing aspects and presentations.

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Johns Hopkins Health Alerts

What’s the Prognosis? Look to the Gleason Score

The most important factor in predicting the current state of the prostate cancer and the success of any treatment is the Gleason score. The Gleason score is based on tumor grade, which is an indication of the tumor’s aggressiveness. The tumor grade reflects how far the cancer cells deviate from normal, healthy cells.

Normal prostate epithelial cells form highly organized glands, with well-defined borders. Cancer cells, in contrast, display various degrees of disorganization and distortion. Cancers whose cells appear closest to normal are considered grade 3 and generally are the least aggressive; those with highly irregular, disorganized features are classified as grade 4 or 5 and generally are the most aggressive.

The Gleason score is derived by determining the two most prevalent organizational patterns in the tumor, assigning each a grade and then adding the two numbers together. For example, if the most common pattern — the primary grade — is 3 and the next most common pattern — the secondary grade — is 4, the Gleason score would be 7 or 3+4. But if the primary grade is 4 and the secondary grade is 3, the Gleason score would be 4+3, and this would be considered to be more aggressive. In other words, the primary grade carries more weight than the secondary pattern in determining the aggressiveness of the cancer.

In some cases the pathologist will report a tertiary pattern that is associated with prognosis but is not a part of the overall score. For example, a pathologist may report that the biopsy shows a Gleason 3+3 (score 6), with a tertiary pattern 4.

Bottom line. Most doctors classify a Gleason score of 6 as a low-grade tumor, a Gleason score of 7 as intermediate, and Gleason scores of 8, 9 and 10 as high grade. Gleason scores of 8 to 10 are associated with the least favorable outlook.

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PHYSICIAN’S FIRST WATCH for June 12, 2014

David G. Fairchild, MD, MPH, Editor-in-Chief

New Guidelines on Follow-Up Care for Prostate Cancer Survivors

By Kelly Young
Edited by
– Susan Sadoughi, MD, and
– Lorenzo Di Francesco, MD, FACP, FHM

<http://onlinelibrary.wiley.com/doi/10.3322/caac.21234/full>

The American Cancer Society has issued its first set of guidelines for the long-term care of prostate cancer survivors in the primary care setting. Among the recommendations, published in CA: A Cancer Journal for Clinicians:

— Serum prostate-specific-antigen (PSA) levels should be assessed every 6 to 12 months for the first 5 years, then measured annually. Patients with elevated or rising PSAs should be referred to their primary treating specialists.
— Patients should be assessed for physical and psychosocial effects of the cancer and treatment. For instance, patients who’ve had radiation treatment may be at increased risk for bladder and colorectal cancers and may need to adhere to screening guidelines for high-risk patients.
— Men who underwent androgen-deprivation therapy are at increased risk for anemia, so complete blood counts should be performed annually.
— Physicians should talk with their patients about sexual function and use validated tools (e.g., the Sexual Health Inventory for Men) to assess erectile function over time.

Link(s):
CA: A Cancer Journal for Clinicians article (Free) <http://click.jwatch.org/cts/click?q=227%3B68014410%3BrWzCXVYKr7l9N1%2By14NGckd6hrVJSysodn%2BkJQWMwSU%3D>

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For those of you still getting the annual PSAT and DRE, and I hope that’s most of you, remember, the magic number for PSA velocity or annual increase in the PSAT score is 0.75 ng/mL, regardless of whether you are above or below that 4.0 ng/mL mark. Catching a diagnosis early makes a huge difference in treatment options and survivability. — Stan

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Johns Hopkins Health Alerts

What We Can Learn from PSA Density and PSA Velocity

The diagnosis of prostate cancer typically begins with an abnormal prostate-specific antigen (PSA) test or perhaps a worrisome finding on a digital rectal exam. To improve the accuracy of the PSA test, many doctors also look at PSA density and PSA velocity. Here’s a brief description at these two important tests.PSA density takes the size of a man’s prostate into account when evaluating his PSA level. It is calculated by dividing the PSA value by the size of the prostate (as determined by transrectal ultrasound). This measurement helps doctors distinguish between benign prostatic enlargement and prostate cancer.The higher the PSA density, the greater the chance of cancer, because the elevated PSA level is less likely to be the result of benign prostate enlargement. Several studies have found that a PSA density greater than 0.15 indicates a higher risk of cancer. PSA density appears most useful in diagnosing prostate cancer in men with PSA levels between 4 ng/mL and 10 ng/mL.PSA velocity takes into account annual changes in PSA values, which rise more rapidly in men with prostate cancer than in men without the disease. A study from Johns Hopkins and the National Institute on Aging found that an increase in PSA level of more than 0.75 ng/mL per year was an early predictor of prostate cancer in men with PSA levels between 4 ng/mL and 10 ng/mL.PSA velocity is especially helpful in detecting early cancer in men with mildly elevated PSA levels and a normal digital rectal exam. It is most useful in predicting the presence of cancer when changes in PSA are evaluated over at least one to two years. In a study reported in the New England Journal of Medicine, a rapid rise in PSA level (more than 2 ng/mL) in the year before prostate cancer diagnosis and surgical treatment predicted a higher likelihood that a man would die of his cancer over the next seven years.Moreover, a Johns Hopkins study published in the Journal of the National Cancer Institute found that a man’s PSA velocity 10 to 15 years before he was diagnosed with prostate cancer predicted his survival from the disease 25 years later. In the study, 92 percent of men with an earlier PSA velocity of 0.35 ng/mL or less per year had survived, compared with 54 percent of men whose PSA velocity was greater than 0.35 ng/mL.

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ASCO: No benefit for immediate ADT after PSA-only relapse

asco-blausenmedical

(HealthDay)—For men with a prostate-specific antigen (PSA)-only-based relapse after prostate surgery or radiation therapy, there seems to be little or no survival benefit for immediate initiation of androgen deprivation therapy (ADT). These findings have been released in advance of presentation at the annual meeting of the American Society of Clinical Oncology, held from May 30 to June 3 in Chicago.

Xabier Garcia-Albeniz, M.D., from the Harvard School of Public Health in Boston, and colleagues examined the optimal timing to start ADT in patients with rising PSA as the only sign of relapse. Participants included 2,022 men in the Cancer of the Prostate Strategic Urologic Research Endeavor, staged 0.2 ng/mL [RP] or three rising determinations one month apart [RT]). Patients who initiated ADT within three months of PSA were assigned to the immediate strategy, while those who initiated ADT two or more years after PSA relapse or when they presented with metastasis, symptoms, or a short PSA doubling time were assigned to the deferred strategy. The median follow-up was 53.2 months after relapse.

The researchers found that for immediate versus deferred ADT, the hazard ratio for all-cause mortality was 1.06 (95 percent confidence interval, 0.59 to 1.89), corresponding to a −5.5 percent survival difference at five years. The hazard ratio for prostate-cancer specific mortality was 1.48 (95 percent confidence interval, 0.69 to 3.16), corresponding to a −5.6 percent survival difference.

“These findings suggest that there may be no need to rush to ADT,” Garcia-Albeniz said in a statement.

The study was partially funded by a grant from Abbott.

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Us TOO Newsletter

Click here to read the May issue of the newsletter featuring Dr.
Ojemuyiwa’s presentation “Hormone Therapy 101”.

http://www.cpdr.org/patient-information/ustoo/0514.pdf

And a number of interesting articles on a variety of subjects to include watchful waiting, Vitamin D, Xtandi, testosterone treatment, hormone therapy.

 

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FDA:  Risk for Venous Thromboembolism with All Testosterone Products

By Kristin J. Kelley
Edited by
– Susan Sadoughi, MD, and
– Jaye Elizabeth Hefner, MD

The FDA is requiring an expanded label change to all approved testosterone products to warn of the increased risk for venous thromboembolism. Labels currently address the risk for clots associated with polycythemia caused by testosterone treatment.

The action follows reports of blood clots in testosterone users unrelated to polycythemia. The agency says the warning is not related to an ongoing investigation announced in January about possible cardiovascular risks associated with testosterone treatment.

Link(s):
FDA drug safety update (Free) http://click.jwatch.org/cts/click?q=227%3B68019892%3BAHDuS8uFDS0TcM1ydxrknbQmO9X%2BfdY89aABHymKTgk%3D
Earlier FDA drug safety communication about testosterone products and risk for stroke and heart attack (Free) http://click.jwatch.org/cts/click?q=227%3B68019892%3BAHDuS8uFDS0TcM1ydxrknQ1QheSUpMAd9aABHymKTgk%3D
Background: First Watch coverage of heightened FDA concern (Free) http://click.jwatch.org/cts/click?q=227%3B68019892%3BAHDuS8uFDS0TcM1ydxrkne4B8mb11vb39aABHymKTgk%3D

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Beckman Coulter’s Prostate Health Index (phi) Available Nationwide for Better Prostate Cancer Detection

May 19, 2014

Brea, CA /PRNewswire/ – Beckman Coulter Diagnostics, a global leader in prostate cancer diagnostics, announces national availability of the Prostate Health Index (phi)*, a simple, non-invasive blood test that is three times more specific in detecting prostate cancer1 than PSA (prostate-specific antigen). The new test’s accuracy decreases the need for many men who test positive for elevated PSA levels to undergo a biopsy in order to achieve a reliable diagnosis.
The most widely used screening test for prostate cancer is currently the PSA test, which measures the blood’s level of PSA—a protein that is naturally produced by the prostate gland and is typically increased when cancer is present. However, it is widely recognized that PSA results can often indicate the possibility of prostate cancer when none is present.

“The PSA test is based on the fact that men with higher levels of the PSA protein are more likely to have prostate cancer,” saidWilliam Catalona, MD, principal investigator on the Prostate Health Index clinical study and urologist at Northwestern Medicine and director of the Clinical Prostate Cancer Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, where they began using the phi test on patients in February. Dr. Catalona, who was the first physician in the U.S. to run the phi test, added, “However, the problem is that higher levels of PSA can also be caused by a benign enlargement or inflammation of the prostate, leading to many false-positives for cancer and ultimately unnecessarily invasive biopsies and an increased potential for patient harm.”

The substantial increase in accuracy of the phi test over PSA addresses this concern. Results of a multi-center clinical study found a 31 percent reduction in unnecessary biopsies due to false-positives as a result of using the phi test.1
“The phi test helps physicians distinguish prostate cancer from benign conditions by utilizing three different PSA markers (PSA, freePSA and p2PSA) as part of a sophisticated algorithm to more reliably determine the probability of cancer in patients with elevated PSA levels,” said Kevin Slawin, MD, director, Vanguard Urologic Institute at Memorial Hermann Medical Group, clinical professor of Urology at Baylor College of Medicine and director of Urology, Memorial Hermann Hospital-Texas Medical Center, who performed some of the key research that led to the development of the phi test and who also began using the test in February. “We have seen first-hand how phi is much more accurate and reduces the need for prostate biopsies. And, the fact that phi is a simple blood test has been very appealing to our patients.”

The phi test is now available to physicians nationwide through Innovative Diagnostics Laboratory (IDL), a national clinical reference laboratory specializing in personalized blood-based testing to find, understand and treat cancer.
“The phi test is a true advancement in the science of prostate cancer management and we are excited to be the first laboratory to offer this test to physicians throughout the U.S.,” said Tonya Mallory, CEO, president and co-founder of Innovative Diagnostics Laboratory. “The Prostate Health Index is a significant addition to our comprehensive menu of advanced clinical evidence-based blood tests that aid in early cancer detection.”
“After years of collaboration with some of the world’s leading prostate cancer researchers and medical institutions who have studied the scientific and clinical benefits of phi, we are pleased that the test is now available to help physicians and patients with an elevated PSA test result, more accurately detect prostate cancer2,” said John Blackwood, senior vice president, Chemistry/Immunoassay Business Unit, Beckman Coulter Diagnostics.
For information on phi and how to order the test, visit: http://prostatehealthindex.us

About Beckman Coulter

Beckman Coulter Diagnostics develops clinical diagnostic products that help advance and optimize the clinical laboratory. Based in Brea, Calif., Beckman Coulter’s instruments, systems and tests help streamline processes to enhance efficiency, reduce costs and speed the delivery of results. For more than 75 years, Beckman Coulter has been a global leader devoted to providing solutions to laboratories of all sizes �“ offering a broad portfolio of chemistry, immunoassay, hematology, urinalysis, automation and information systems. Beckman Coulter is, and always has been, singularly devoted to moving science, innovation and the lab forward. For more information, visit https://www.beckmancoulter.com.

1 Beckman Coulter U.S. Prostate Cancer Pivotal Study Report
2 Hybritech p2PSA Instructions For Use
* The Prostate Health Index is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, for prostate cancer detection in men aged 50 years and older with total PSA ≥ 4.0 to ≤ 10.0 ng/mL, and with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.
Beckman Coulter and the stylized logo are trademarks of Beckman Coulter, Inc. and are registered in the USPTO.
SOURCE: Beckman Coulter
Copyright 2014 PR Newswire. All Rights Reserved

Additional information on the PHI Test is at American Urological Association article “PROSTATE HEALTH INDEX (PHI), A MORE PRECISE BLOOD TEST, OUTPERFORMS TRADITIONAL PSA SCREENING IN PREDICTING CLINICALLY SIGNIFICANT PROSTATE CANCER” at this link.

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Men with PSA-Only Relapse Might Safely Defer Androgen Deprivation Therapy, Study Suggests
By Amy Orciari Herman

May 14, 2014

For men who develop prostate-specific-antigen relapse alone after treatment for prostate cancer, immediate initiation of androgen-deprivation therapy (ADT) offers no survival benefit over delayed ADT, according to an abstract from an observational study released on Wednesday.

Using a national cancer registry, researchers studied some 2000 men with PSA relapse and no other signs of cancer recurrence who either underwent immediate ADT or deferred treatment for at least 2 years or until they developed metastasis, symptoms, or worsened PSA. During some 4.5 years’ follow-up, neither all-cause mortality nor prostate-cancer-specific mortality differed between the groups.

The study will be presented later this month at the annual meeting of the American Society of Clinical Oncology.

Link(s):
ASCO abstract (Free) 
New York Times story (Free) 

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The article below is at  this link.

A Better Prostate Cancer Test Is Here

Monday, 31 Mar 2014 08:18 AM

By Steve Plamann

From http://investor.opko.com/releasedetail.cfm?ReleaseID=836567 “The 4KscoreTM Test was developed by OPKO Lab, a division of OPKO Health, and tested in collaboration with 26 Urology centers across the United States from October 2013 to March 2014. Results showed that the 4Kscore TestTM was highly accurate for predicting the presence of high-grade cancer (Gleason score 7 or higher) prior to prostate biopsy. The full data from the blinded, prospective U.S. clinical validation study will be presented at the AUA Annual Meeting in Orlando, FL on May 18th at Plenary Session I.”

Until recently, the PSA test for prostate cancer had been a routine part of every middle age man’s physical. But it has fallen out of favor as doctors realized the PSA was leading many men to have needless and painful prostate biopsies and unnecessary cancer treatments.

In fact, major medical groups have stopped recommending routine PSA testing for most men.

But now a better prostate cancer test has become available to help address the problem.

It’s called the 4Kscore Test. Instead of testing for only one biomarker of prostate cancer as the PSA test does, the 4Kscore tests for four biomarkers and adds a man’s age, his digital rectal exam result, and whether or not he has had a prior prostate biopsy to come up with his score. The 4Kscore is a man’s probability for having life-threatening prostate cancer, and allows their doctors to add this to the PSA and other clinical information to gauge whether a prostate biopsy is necessary.

“Our clinical data demonstrated that the 4Kscore could help to reduce unnecessary biopsies by providing more accurate information on the probability of high-grade prostate cancer,” said David Okrongly, president of OPKO Diagnostics (NYSE: OPK), the maker of the test.

“It will offer both the urologist and the patient better information to make a more informed decision about having a prostate biopsy.”

Currently, about 80 percent of prostate biopsies ultimately prove to be unnecessary because they are either negative for cancer or show a low-grade disease that is no threat to health. Besides being painful, biopsies carry a significant risk of bleeding and infection.

Like the PSA test, the 4Kscore test involves a simple blood draw. It was developed by OPKO, a leading biopharmaceutical and diagnostics company, based upon research performed at Memorial Sloan Kettering Cancer Center in New York and research centers in Europe where more than 10,000 men have been studied with the test.

Prostate cancer is the second most deadly cancer in American men according to the National Cancer Institute. In 2014, some 29,480 men are projected to die from the disease and some 233,000 more will be diagnosed with it.

Okrongly notes that “over 1 million biopsies will be performed in the US in 2014, and with better information, that number could be significantly reduced to the benefit of the patient and the overall cost of healthcare.”

The test is available for the first time starting today, March 31. Men who think they may be candidates for the 4Kscore should have their doctor contact OPKO through its website http://www.opko.com.

The cost of test is $395 and the company expects that it will be covered by insurance within 12 to 18 months after launch.

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Accelerating the World’s Most Promising Research – March 2014

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Featured News from PCF
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Statins and Prostate Cancer

As the science comes together, risk of aggressive disease may be abated with use, but little effect on indolent, early prostate cancers.

*Full Story – http://www.pcf.org/prostate-cancer-research/research-news/treatment-outcomes/statins-and-prostate-cancer

Ask the Doctor: Calcium Supplements and Prostate Cancer Risk

Q: I’ve read that taking calcium supplements or using too many antacids that have calcium in the tablets can increase the risk of prostate cancer. Is this true? Also, what can I do to keep my bones strong while I’m on androgen deprivation therapy?

A: by Edward Giovannucci, MD, ScD, of Harvard School of Public Health

*Full Story – http://www.pcf.org/prostate-cancer-research/research-news/screening-diagnosis-and-prognosis/ask-the-doctor/edward-giovannucci

News in Brief

Localized Prostate Cancer Better Controlled with More Intensive Radiotherapy

*Full Story – http://www.pcf.org/prostate-cancer-research/research-news/news-in-brief/localized-prostate-cancer-better-controlled-with-the-more-intensive-radiotherapy

PCF researchers discover molecular crosstalk that prostate cancer cells use to survive radiation therapy; plan steps to halt that “conversation”

Prostate Cancer Foundation-funded researchers published two studies this fall that help explain why androgen deprivation therapy improves survival when given with radiation therapy; ability to repair broken DNA implicated. Findings may predict which men are most likely to benefit from combination therapy, and could lead to novel treatments for advanced prostate cancer.

*Full Story – http://www.pcf.org/prostate-cancer-research/research-news/research-therapeutics/pcf-researchers-discover-molecular-crosstalk-that-prostate-cancer-cells-use-to-survive-radiation-therapy

NEJM Study Finds Surgery May Benefit Younger Prostate Cancer Patients

Dr. Jennifer Rider, a Prostate Cancer Foundation Young Investigator, is a co-author on a new study published in The New England Journal of Medicine that adds fodder to the operate vs. “watch-and-wait” debate.

*Full Story – http://www.pcf.org/prostate-cancer-research/research-news/treatment-outcomes/study-adds-fodder-to-the-operate-vs-watch-and-wait-debate

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Physician’s First Watch <FirstWatch@jwatch.org>

Swedish Study Suggests Threshold for Further PSA Screening After Age 60

By Kelly Young

Prostate-specific-antigen (PSA) screening after age 60 should focus on men with PSA levels at or above 2 ng/mL, according to a BMJ study.

Nearly 1800 Swedish men who received baseline PSA screening at age 60 were compared with an unscreened cohort of 1200 men whose PSA levels were assessed retrospectively through blood samples they provided at age 60.

Overall, screened men had more prostate cancer diagnoses than unscreened men at 15 years, but there was no difference in cancer-related mortality or metastasis. Only men with PSA levels of 2 ng/mL or higher saw a mortality benefit — 23 men needed to be screened and 6 needed to be diagnosed to prevent one prostate-cancer death by 15 years. 

The authors conclude: “For men with a PSA concentration <1 ng/mL at age 60, no further screening is recommended … Screening men with a PSA level of 1-2 ng/mL is an individual decision to be based on a discussion between patient and doctor.”

In the U.S., guidelines for PSA screening vary, with one group recommending against routine screening and another limiting “routine” screening to those aged 55 to 69.

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Androgen Deprivation Therapy for Localized Prostate Cancer

Summary and Comment |Oncology and Hematology

Informing Practice
March 19, 2014
Robert Dreicer, MD, MS, FACP reviewing Potosky AL et al. J Clin Oncol 2014 Mar 17.

Primary ADT has little utility for most patients who do not undergo curative-intent treatment.

Although the use of primary androgen deprivation therapy (ADT) as monotherapy in men with clinically localized prostate cancer may be slowly declining, recent evidence suggests that it remains a frequently used management approach for men older than 65. Moreover, previous risk-benefit assessments of primary ADT in this population have provided mixed results.

Now, investigators have conducted a retrospective cohort study of 15,170 patients from one of three health plans with newly diagnosed, clinically localized prostate cancer who had not undergone curative-intent treatment with radiotherapy or surgery. Of these patients, 23% (median age, 76) received primary ADT within 12 months of initial diagnosis, and 77% (median age, 69) did not receive primary ADT. Patients who received ADT had worse prognostic factors, including higher Gleason scores and prostate-specific antigen values.

Patients who received primary ADT versus those who did not experienced higher rates of all-cause mortality (49% vs. 28%) and prostate cancer–specific mortality (13% vs. 5%). However, when the analysis was adjusted for clinical and sociodemographic features, primary ADT was associated with a decreased risk for all-cause mortality but not prostate-cancer–specific mortality for most patients.

Comment

These results add to the weight of evidence that primary androgen deprivation therapy has little utility for most men with clinically localized prostate cancer who, for a variety of reasons, are not managed with curative intent. The adverse effects and economic burden of ADT should be carefully weighed in this clinical setting.

Editor Disclosures at Time of Publication

Citation(s):

Potosky AL et al. Effectiveness of primary androgen-deprivation therapy for clinically localized prostate cancer. J Clin Oncol 2014 Mar 17; [e-pub ahead of print]. (http://dx.doi.org/10.1200/JCO.2013.52.5782)
– See more at: http://www.jwatch.org/na34041/2014/03/19/androgen-deprivation-therapy-localized-prostate-cancer?query=etoc_jwonchem#sthash.9x6cUxRP.dpuf

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18-Year Follow-Up Confirms Benefit of Prostatectomy Over Watchful Waiting in Early Cancer

By Amy Orciari Herman

Prostatectomy is associated with lower prostate-cancer mortality than watchful waiting even after nearly 20 years of follow-up, according to long-term results from the Scandinavian Prostate Cancer Group Study Number 4, published in the New England Journal of Medicine.

Some 700 men with early prostate cancer were randomized to radical prostatectomy or watchful waiting. The cumulative incidence of disease-specific mortality at 18 years was reduced in the surgery group versus the observation group (18% vs. 29%). The reduction was significant only for men younger than 65, in whom the number needed to treat to prevent one prostate cancer death was four.

Among men aged 65 and older, prostatectomy was associated with significantly lower risks for metastases and need for palliative therapy.

In terms of morbidity, the groups had similar rates of erectile dysfunction (roughly 80%), but the surgery group had a higher incidence of urinary leakage than the watchful-waiting group (41% vs. 11%).

Link(s):

NEJM article (Free abstract) http://click.jwatch.org/cts/click?q=227%3B67967527%3BHSRXhcnQBYNxBrzYZh6U8nxahw56DtcHqKPA4%2BmtuNc%3D

Background: NEJM Journal Watch coverage of study’s 13-year results (Free) http://click.jwatch.org/cts/click?q=227%3B67967527%3BHSRXhcnQBYNxBrzYZh6U8uC5l9rYFCc0qKPA4%2BmtuNc%3D

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Research News

<http://www.pcf.org/site/c.leJRIROrEpH/b.8968717/k.695D/Exercise_and_Prostate_Cancer8212the_evidence_stacks_up_for_benefits.htm>

Exercise and Prostate Cancer­: the evidence stacks up for benefits

New research adds credence for why men ought to exercise both before and after a prostate cancer diagnosis to maximize their chances of longer survival and/or improved quality of life.

January 27, 2014 — A growing body of research suggests that exercise benefits men with prostate cancer, and now a new study may have determined one of the reasons why. In findings presented by several PCF-funded researchers this week in San Diego at the American Association for Cancer Research – Prostate Cancer Foundation Conference on Advances in Prostate Cancer Research, men with a history of brisk walking prior to a diagnosis of prostate cancer had healthier-looking, more normally shaped blood vessels in their prostate tumors after diagnosis.

The researchers had previously shown that small, irregularly shaped vessels in human prostate tumors were linked to an increased risk of death in men with prostate cancer. “We hypothesized that brisk walking and vigorous activity would be associated with larger, more regularly shaped vessels in human prostate tumors,” says the researchers.

To test their theory, they reviewed the self-reported physical activity levels of 572 men in the Health Professionals Follow-up Study prior to a diagnosis of prostate cancer. All the men in the study underwent surgery to remove their prostate gland after their cancer was diagnosed. The researchers examined post-surgical tissue samples of these men and found that those who reported the fastest walking pace (3.5 to 4.5 mph) prior to their diagnosis of prostate cancer had more normally shaped blood vessels in their tumors compared to men with the slowest walking pace (1.5 to 2.5 mph).

This may be quite important, say the researchers, because more normally shaped vessels in prostate tumors may inhibit cancer spread in the body and might also improve men’s response to anti-cancer therapies.

“It’s easy for people to see the obvious benefits exercise has on the outside of the body, but harder to imagine that it may have positive internal effects on the prostate itself,” says Dr. Lorelei Mucci, a PCF Young Investigator and an author on the study. “But this study documents the benefits exercise can confer to a prostate tumor, which may make that tumor less of a threat to the man’s life,” she says.

Interestingly, and somewhat surprising to the researchers, says Mucci, was that while brisk walking was associated with a positive effect on the shape of a tumor’s vasculature, more vigorous levels of exercise, such as running or cycling, did not seem to have an effect of tumor vessel shape. “Vigorous exercise, such as running or rapid cycling, is associated with a decreased risk of dying of prostate cancer,” says Mucci, “but from these findings, it seems as though the benefits to men from higher levels of exercise may be coming from a different mechanism of action.” Mucci and another PCF-funded researcher, Dr. Steven Finn, are currently studying the effects of exercise on tumor cells that have broken free from the prostate gland and entered the circulatory system.

Key Points: Men who regularly walked at a brisk pace of 3.5 mph or greater before any prostate cancer diagnosis, had more normally shaped blood vessels in their tumors once a cancer did develop. Malformed blood vessels in a prostate tumor have been associated with an increased risk of developing lethal cancers.

Other studies show benefits of exercise for men with prostate cancer.

Dr. Stacey Kenfield, a Prostate Cancer Foundation Young Investigator and a presenter on the Brisk Walking study, also first-authored a study published in the Journal of Clinical Oncology in 2011 that looked at physical activity and outcomes for men in the Health Professionals Follow-up Study diagnosed with prostate cancer. That study found that:

Men who walked briskly for 90 minutes or more per week lower their risk of death from any cause by 46% compared to men who men who walked less quickly and less often.

Men who exercised vigorously (e.g., biking, tennis, jogging, swimming) three or more hours per week had a 61% lower risk of death from prostate cancer compared to men who exercised vigorously less than one hour per week.

Both non-vigorous and vigorous activity lowed men’s risk of death from any cause.

And a brand new study, published this month in the Journal of Physical Activity & Health, found that men diagnosed with cancer who burned 12,600 kilojoules (kJ) or more a week doing physical exercise (such as walking or stair climbing) cut their risk of death from any cause by half, compared to men whose weekly exercise burns only added up to 2,100 kilojoules a week. (12,000 kJ converts to 3,011 calories.)

Hitting that level of energy burn requires clearance from your doctor and personal commitment: a 170-pund man who walked briskly (pace 3.5 mph) for an hour and a half, seven days a week, would burn 12,887 kilojoules, or 3,080 calories a week.

Another PCF-funded researcher who was an author on the Brisk Walking study presented at this week’s AACR-PCF meeting, Dr. June Chan of the University of California, San Francisco, has reported in the past that vigorous exercise changes the expression of 184 genes; specifically, Chan reported at the 2012 American Society of Clinical Oncology annual meeting that several genes thought to thwart cancer progression were up-regulated in men who exercised vigorously three hours a week, or more.

Understanding how exactly exercise benefits men with prostate cancer is important, says Dr. Jonathan Simons, president and CEO of PCF, because once scientists know what genetic or other biological changes are in play that can extend survival, it might be possible to formulate therapies that mimic, or even enhance, the benefits of physical activity. Additionally, such knowledge may help explain why some men with prostate cancer who have always exercised robustly, progress in their disease, despite that fact.

“Knowledge is power,” agrees Dr. Howard Soule, chief science officer of PCF, “and this new [AACR-PCF] study on brisk walking and tumor vessel morphology definitely raises the bar for what we know in terms of how exercise may affect men with prostate cancer.” Soule adds that the time may be ripe now for funding a prospective study to more definitively address this issue.

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An Aspirin a Day to Keep the Prostate Cancer at Bay?

PCF Young Investigator, Dr. Jennifer R. Rider of Brigham and Women’s Hospital and the Harvard School of Public Health looks into what impact aspirin therapy might have on prostate cancer. (Video) Also, Questions to Ask your Doctor Regarding Aspirin Use, and this admonition: please, don’t self-treat.

* Full Story – http://www.pcf.org/research-news/research-therapeutics/an-aspirin-a-day-to-keep-the-prostate-cancer-at-bay

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This is a lengthy article with a couple of videos that explores the difficulties associated with conducting controlled studies on the effectiveness of aspirin on preventing or controlling PC. It also discusses the mechanisms involved in how aspirin might help in PC prevention and control. — Stan

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Mixed reviews on Essiac:

1. American Cancer Society: “Essiac Tea”

http://tinyurl.com/q4uxpfo

“Overview: There have been no published clinical trials in conventional medical journals showing that either Essiac tea or Flor Essence helps in the treatment of cancer. Some of the specific herbs contained in the mixture have shown some anti-cancer effects in laboratory experiments. However, most laboratory studies of Essiac have found it didn’t work against cancer cells, and one reported that Flor Essence increased the growth of breast cancer cells. Available scientific evidence does not support its use for the treatment of cancer in humans.”

2. PubMed: “Evaluation of the antiproliferative effects of Essiac on in vitro and in vivo models of prostate cancer compared to paclitaxel.”

http://www.ncbi.nlm.nih.gov/pubmed/17640165

“Abstract — Essiac, a widely consumed, sparsely tested herbal tea, was evaluated for preparation consistency and antiproliferative effects on prostate cancer cells and xenografts. High performance liquid chromatography (HPLC) was used to compare different lots of Essiac and evaluate extraction consistency by comparing peak areas in concentrated preparations. Repeated analysis of one lot showed < 2% RSD between corresponding peaks. Absolute peak areas varied widely between lots, but similarity in relative size of corresponding peaks was observed. Cytotoxic effects of Essiac were tested in vitro by crystal violet assay and analysis of cell cycle distribution by flow cytometry, but no differences between control and treatment groups was observed. Paclitaxel was used as a positive control in cell cycle analysis and was the only treatment which showed significant effects on cell cycle distribution. Toxicity in nude mice was tested, and efficacy in inhibiting PC-3 xenograft growth. No toxicity or tumour size difference was observed dosing up to 240 mg/kg QD, over 28 days, excepting the positive control group treated with paclitaxel. Ki-67 and PCNA expression was analyzed in treated tumors, but no difference in expression of either marker was observed. These evaluations suggest Essiac has no marked antiproliferative effect on the models tested.”

3. Memorial Sloan Kettering: “Integrative Medicine — Essiac”

http://www.mskcc.org/cancer-care/herb/essiac

“Clinical Summary– Essiac was developed in the 1920s by Rene Caisse, a Canadian nurse. It is a formulation of four botanicals: burdock root, sheep sorrel root, slippery elm bark, and rhubarb root.

“Essiac demonstrated antioxidant  and cytotoxic properties in vitro, but stimulated growth of human breast cancer cells both via estrogen receptor (ER)-dependent and ER-independent pathways. Similarly, studies of its antiproliferative effects on prostate cancer cells yielded conflicting data. Remission of hormone-refractory prostate cancer was reported in a patient, but a retrospective study of breast cancer patients found that Essiac did not improve quality of life or mood.

“Despite unsubstantiated claims , Essiac remains a popular anticancer therapy today.”

4. PubMed: “Remission of hormone-refractory prostate cancer attributed to Essiac.”

http://www.ncbi.nlm.nih.gov/pubmed/16274521

“Abstract — Essiac is a popular complementary and alternative medicine (CAM) that is utilized by many cancer patients in North America. Much anecdotal reporting exists about its cancer-fighting qualities, but so far no clinical trials have been preformed to validate those claims. We describe here the case of a 64-year-old man whose hormone-refractory prostate cancer responded well to Essiac tea.”   (further info is not available without a subscription)

5. PubMed: “Inhibition of prostate cancer-cell proliferation by Essiac.”

http://www.ncbi.nlm.nih.gov/pubmed/15353028

“Abstract –“OBJECTIVE: To assess the ability of Essiac tea extracts (Essiac Canada International, Ottawa, Canada) to modulate cancer cell proliferation and immune responsiveness.

“DESIGN: A noncancerous transformed cell line was compared to a cancerous cell line and spleen cells that had been isolated from mice to examine proliferation responses mediated by the addition of an Essiac preparation.

“RESULTS: We found in vitro evidence of decreased proliferation of both noncancerous transformed (CHO) and cancerous prostate cell line (LNCaP) when Essiac was present in the culture media. A dose response for inhibition was demonstrated by a linear regression performed on the data for both the CHO and LNCaP cells. The percent inhibition of the LNCaP cells was higher than the percent inhibition of the CHO cells suggesting that Essiac may have a more selective effect on cancer cells than transformed cells. In addition, the effects of Essiac were examined in an immune T-lymphocyte proliferation assay. At low doses of Essiac, augmentation of proliferation of these T cells was demonstrated, but at higher doses Essiac was inhibitory to T-cell proliferation. The same doses of Essiac that stimulated spleen cells were inhibitory for LNCaP cell proliferation.

“CONCLUSIONS: Essiac preparations may be able to inhibit tumor cell growth while enhancing immune response to antigenic stimulation. This may be especially valuable in immune-suppressed individuals.”

6. “Essiac, ‘Tea of Life'” by Samantha Kidwell

http://www.vanderbilt.edu/AnS/psychology/health_psychology/essiac.htm

A brief excerpt — “The History of Essiac: Essiac, the Ojibwa Tea of Life, is an herbal remedy used by the Canadian nurse Rene Caisse to treat and successfully heal thousands of terminally ill cancer patients <http://www.all-natural.com/essiac.html>. When Caisse was working in an Ontario hospital, she met a lady with a badly scarred breast, who told Caisse that she had been healed of breast cancer by an Indian friend with an herbal tea, and then gave her the formula <http://www.all-natural.com/essiac.html>. After that, Caisse began using the formula on many patients, allowing them to drink it or receive it through intramuscular injections (for more serious cases ) <http://www.all-natural.com/essiac.html>. These patients testify to essiac’s good effects as do many renowned doctors, which can lead one to believe in the ability of this herbal tea…”

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My own take on the herbal tea:  Bud’s personal experience is just as good a testimonial as anything I can find on line. It probably can’t hurt (iffy on breast cancer), and, just possibly, it might help. 

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FYI: Vanderbilt University Department of Psychology has an indexed reference list for “health behavior, nutrition, psychotherapy, and alternative medicine.” You might find it useful.

http://www.vanderbilt.edu/AnS/psychology/health_psychology/healthps.HTM

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PSA Test Lowers Risk of Prostate Cancer Death

Monday, 10 Mar 2014 04:34 PM

By Nick Tate

In a new study likely to reinvigorate the debate over the PSA test, researchers from Memorial Sloan Kettering Cancer Center have found areas where the screening is performed more frequently have lower death rates from prostate cancer than those where there is little testing.

The new research, published online in Journal of the National Cancer Institute, contradicts the findings of past studies that have raised questions about the benefits of PSA screening and undercut recent federal guidelines that recommend against routine testing for most men.

The findings ­ by Sloan Kettering scientists, working with cancer specialists from the Umeå University, Sweden ­ are based on an analysis of national Swedish cancer registries. They show that prostate cancer incidence and mortality rates are markedly lower in areas with frequent use of PSA testing compared with regions where little screening is done, Medical Xpress reports.

“Our results show that prostate cancer mortality was 20 percent lower in counties with the highest incidence of prostate cancer, indicating an early and rapid uptake of PSA testing, compared with counties with a slow and late increase in PSA testing,” said lead researcher Pär Stattin.

Håkan Jonsson, a statistician and senior author of the study, added that the findings are based on “real life PSA testing,” as opposed to clinical trials, which have raised questions about the benefits of PSA screening.

“Since the difference in the number of men diagnosed with prostate cancer is related to how many men undergo PSA testing, we think our data shows that PSA testing and early treatment is related to a modest decrease in risk of prostate cancer death,” Jonsson said.

“In contrast to screening in randomized studies our data is based on unorganized, real life PSA testing. We therefore used a statistical method that excludes men that were diagnosed prior to the introduction of PSA testing since these men could not benefit from the effect of PSA testing.”

PSA (prostate-specific antigen) is a protein produced in the prostate gland that is measured in a blood test. Higher levels may signal prostate cancer, but other conditions can raise PSA, including a urinary tract infection, and inflammation or enlargement of the prostate.

PSA screening has been debated for years by prostate cancer specialists because it often catches low-risk cancers that patients are over-treated for with invasive biopsies and surgical removal of the prostate, a procedure that can leave men impotent and incontinent.

he American Urological Association recently recommended against PSA screening for average-risk men younger than 55 and older than 70. The U.S. Preventive Services Task Force has also recommended that men not get routinely screened using the PSA test. It said there was little evidence it saves lives, and can cause harm from the treatment of non-life threatening tumors.

But many men’s health specialists and prostate cancer experts have argued the recommendations are ill-advised and that prostate tests ­ particularly went performed over time, which allows doctors to track trends and changes ­ are very effective in flagging men at risk.

“The results in our study are very similar to those obtained in a large European randomized clinical study [ERSPC] thus confirming the effect of PSA testing on the risk of prostate cancer death concludes,” said Dr. Stattin.

“However, we have to bear in mind that the decrease in mortality is offset by overtreatment and side effects from early treatment. PSA testing sharply increases the risk of overtreatment, i.e. early treatment of cancers that would never have surfaced clinically.

We also know that after surgery for prostate cancer most men have decreased erectile function and that a small group of men suffer from urinary incontinence. Our data pinpoints the need for refined methods for PSA testing and improved prostate cancer treatment strategies.”

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Hormone Therapy: Earlier is Better than Later

Posted: 11 Mar 2014 05:54 PM PDT

BY MARK SCHOLZ, MD

Prostate cancer is by far the most hormonally sensitive cancer. Practically all other types of cancer, except breast cancer, are totally immune to testosterone blockade. Just as normal cells need oxygen, prostate cells, cancerous or otherwise, depend on testosterone. Cells originating in the prostate are by nature very sensitive to testosterone blockade. This sensitivity can be exploited as a treatment. When a cancer cell is deprived of testosterone it initiates a suicide sequence called apoptosis. Low testosterone is acting like a signal, sending a biochemical message to the cell, telling it to release destructive intracellular enzymes, causing it to die.

Within a few months of blocking testosterone, cancer regression is usually dramatic. For example, one study used Zytiga prior to surgery. The surgically removed prostate glands were fine-sliced and examined under a microscope.  Some men showed no residual cancer in their prostates.

The testosterone inactivating pharmaceuticals (TIP) that block testosterone are listed below in order of ascending potency:

  1.    5-alpha reductase inhibitors: Avodart (dutesteride), Proscar (finasteride):
  2. Anti-Androgens: Casodex (Bicalutamide), Eulexin (flutamide), Nilandron (nilutamide)
  3. Orchiectomy: Surgical removal of the testicles
  4. LHRH agonists and antagonists: Lupron, Zoladex, Eilgard, Firmagon
  5. Estrogen: Works basically the same way as #3, by suppressing luteinizing hormone (LH). In addition, however, there also may be some direct anticancer effects from estrogen.
  6. Cyp17 Inhibitors: Zytiga (abiraterone), Nizoral (ketoconazole):
  7. Multimodality androgen receptor inhibition: Xtandi (enzalutamide)

While categories 6 and 7 are clearly the most potent, as yet there is no conclusive evidence that either of these two categories is more potent than the other. However, a variety of studies have demonstrated that a combination of agents is more potent that agents used by themselves.

Also, a number of studies have shown that men live longer when they are treated with TIP at an earlier stage­ that is, at the time of diagnosis ­rather than at the time of relapse when the disease has become more entrenched:  In August 1997, The New England Journal of Medicine published a study comparing two groups of 200 men each, all of whom were treated with radiation for high grade prostate cancer (Gleason 8, 9, or 10 or a large tumor felt on digital rectal exam). The five-year death rate from prostate cancer was reduced by 80% in the men who received radiation plus TIP compared to radiation alone.

A study published in the British Journal of Urology in February 1997 looked at immediate TIP vs. starting TIP after the cancer was causing symptoms.  Two groups of 400 men were evaluated and compared. Mortality was 25% lower in the group that had early treatment.  A third study was published in the Journal of Urology in June 1998 in which ninety-one men were randomized between radiation alone and radiation with TIP.  The mortality rate was 50% less in the men that were treated with TIP.

Another famous study in New England Journal of Medicine authored by Dr. Messing in 1999 looked at the value of starting TIP right after surgery in a 100 men, all of whom had cancer confirmed to have spread into their lymph nodes. Half were randomly allocated to start TIP right after the operation.  The other half started TIP when they had disease recurrence and evidence of progression.  Seven years later the men treated with immediate TIP were eight times less likely to have died of prostate cancer: Two men treated with immediate TIP died of prostate cancer whereas 17 men treated with delayed TIP died of prostate cancer.

In this last study TIP was continued for life. Since we know that TIP has more side effects when administered over a longer period, one can’t help but wonder if the same survival advantage could have been achieved with a shorter treatment period, say for two years?

The side effects of TIP can indeed be troublesome, especially the lowering of libido.  In our experience 70% of men under age 60 and 90% of men over age 65 lose sexual desire completely­particularly if they are treated with drugs in category three or higher. Category two and category one drugs cause loss of libido in about 50% and 25% of men respectively.

It is important to make one thing clear: Libido is not a euphemism for getting an erection. Viagra is powerful enough to restore erections in most men on TIP. Loss of libido means undergoing a loss of sexual interest. After TIP is stopped, younger men recover libido quite nicely though a minority describe their libido as persistently diminished. Some men, particularly the older ones, are more likely to have a persistent reduction in libido.

The list of potential side effects from TIP (besides libido problems) is long. Most of the side effects are manageable with expert supervision. Please inquire about a copy of Preventing the Side Effects of TIP for further details. Using a category two drug like Casodex is one way to reduce TIP’s side effects. However, using a less potent agent raises another concern: Some studies have shown reduced anticancer efficacy. Clearly treatment selection depends on weighing the intensity of potential side effects against the expected survival benefit. In some cases, slightly diminished anticancer efficacy may be an acceptable tradeoff if side effects can be substantially reduced.

Prostate cancer’s Achilles heel is that it can’t survive without testosterone. While anti-testosterone medications have remarkable anticancer efficacy they can also cause notable side effects. Treatment intensity and timing needs to be varied in accordance with each patient’s individual characteristics.

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Xtandi (enzalutamide), the Star of the 10th Annual Genitourinary Meeting 

Posted: 25 Feb 2014 11:24 AM PST

BY MARK SCHOLZ, MD

The GU-ASCO meeting kicks off the first of five annual prostate cancer meetings that are on my calendar to attend every year. The other four meetings are hosted by the American Urological Association (AUA) in May, the PCRI meeting in September, the American Society of Therapeutic Radiation Oncology (ASTRO) that is also in September and the Prostate Cancer Foundation retreat (PCF) that occurs in November.

Since GU-ASCO is the first meeting of the year, the new scientific research presented sets the tone for the whole Year.  This year’s meeting was dominated by the release of a report showing that Xtandi, a potent oral anti-cancer agent, prolongs life compared to placebo when administered prior to the chemotherapy drug Taxotere (a previously published study has already shown that Xtandi prolongs survival when used after Taxotere).

It’s exciting to see an effective pharmaceutical agent get expanded access. This will lead to a greater number of men benefiting with prolonged survival and better quality of life. The bare bones of this groundbreaking report are summarized here:

Abstract #1: Enzalutamide in men with chemotherapy-naive metastatic prostate cancer. Results of the phase III PREVAIL study.

In this randomized, double-blind, placebo-controlled, multinational phase 3 study, chemotherapy-naive patients with metastatic hormone-resistant disease were treated with either enzalutamide or placebo.

Results: A total of 1,717 men were enrolled. Final results showed a significant benefit of enzalutamide over placebo with a 30% reduction in risk of death and an 81% reduction in risk of radiographic progression or death. At the time of the analysis, 28% of enzalutamide patients and 35% of placebo patients had died.

The findings of this study almost certainly indicate that the FDA will approve Xtandi for use prior to Taxotere and in the near future,  Xtandi will compete head to head with Zytiga and Provenge, both of which are already FDA-approved for men in the pre-chemo category.

The fact that FDA approval is almost guaranteed means that doctors are going to start asking a very important question:  What is the optimal way to sequence these three medications?

Presently there is no clear answer about whether Zytiga should be before Xtandi or vice versa. However, there are several very strong arguments that Dendreon’s product, Provenge, a medication that works by stimulating the immune system, should go first:

1.   Provenge only takes 6 weeks to administer, so there is no problem adding other anticancer agents after Provenge administration is complete.

2.   Immune treatments in general are thought to work better when initiated at an earlier stage, before the cancer becomes more entrenched and starts to suppress immune function.

3.   Provenge changes the immune system in a fashion that keeps working indefinitely after the initial 6-week treatment period is passed.

4.   Because insurance only pays for Provenge in men with rising PSA levels, starting Xtandi or Zytiga, both effective in lowering PSA, can substantially delay the initiation of Provenge.

There seems to be broad consensus that Provenge should be first in line.  The real question then is, What should come second, Xtandi or Zytiga?

At the GU-ASCO meeting there were a number of reports, including a report from our office, that show reduced anticancer effects of Xtandi when used after Zytiga.  This is hardly surprising since the phenomena of progressively increasing cancer resistance with each cycle of therapy have been known about for 30 years. Preliminary reports also show a reduced Zytiga response-rate when it is used after Xtandi.

While these reports document that the first agent selected is likely to be used for a much longer time period than the agent that follows, so far there are no studies evaluating whether sequencing  affects overall survival.  Xtandi clearly has reduced anticancer activity after Zytiga. The same, however, has also been observed in reports evaluating Zytiga in men who have previously failed Xtandi.

The jury is still out. Until further comparative studies are performed, no one knows if there is an advantage to using Zytiga first or Xtandi first.  Presently however, I think most experts are assuming that Xtandi and Zytiga seem to have similar overall anti-cancer potency, the preference of sequencing one agent over the other to be first in line is unlikely to have a major impact on overall longevity.

full article – click here

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Physician’s First Watch, February 24, 2014

Prostatectomy Confers Greater Survival Benefit Than Radiotherapy in Nonmetastatic Cancer

By Amy Orciari Herman

Among men with nonmetastatic prostate cancer, prostatectomy appears to reduce disease-specific mortality better than radiotherapy, an observational study in BMJ finds.

Using the Swedish national prostate cancer registry, researchers examined outcomes among nearly 35,000 men who underwent radical prostatectomy or radiotherapy as their primary treatment between 1996 and 2010. Median follow-up was 5 years.

Among men with nonmetastatic disease, prostate cancer mortality was significantly lower with surgery than with radiotherapy (1.4% vs. 4.9%). Men who were younger, had fewer comorbidities, and had higher-risk cancer appeared to benefit most from surgery.

Among men with metastatic cancer, on the other hand, disease-specific mortality did not differ according to treatment.

The authors, while acknowledging limitations to their research, conclude: “Our study suggests that surgery might result in improved outcomes compared with radiotherapy in terms of survival for men with non-metastatic prostate cancer.”

Link(s):

BMJ article (Free)

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PHYSICIAN’S FIRST WATCH for February 24, 2014

Supplements Meant to Prevent Prostate Cancer Can Actually Increase Risk

By Joe Elia

The suspected deleterious effect of supplementing men’s diets with selenium or vitamin E in an effort to prevent prostate cancer has apparently been confirmed. The findings appear in the Journal of the National Cancer Institute.

Researchers examined data from the SELECT trial, which examined whether supplemental selenium, vitamin E, or both could lower prostate risk. They found that men with low baseline selenium levels (as measured in toenail samples) did not benefit from selenium supplements alone or combined with vitamin E. And in fact, those with higher baseline selenium showed a significantly increased risk for high-grade prostate cancer with selenium supplementation.

For their part, vitamin E supplements alone had no effect in men with higher baseline selenium levels, but they increased risks for all grades of prostate cancer among those with lower baseline selenium.

The authors conclude that men over 55 should avoid both selenium and vitamin E supplements that exceed recommended dietary levels.

Link(s):

JCNI article (Free abstract)

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PHYSICIAN’S FIRST WATCH for February 21, 2014

David G. Fairchild, MD, MPH, Editor-in-Chief

Endocrine Society Offers Statement on Testosterone Therapy After Recent Reports

By the Editors

In the wake of recent studies pointing to increased risks for cardiovascular events after testosterone therapy, the Endocrine Society has issued a statement, dated February 7, that concludes: “Large scale, prospective, randomized controlled trials are needed to determine the risks and benefits of testosterone therapy in older men with age-related decline in testosterone levels.”

Until that evidence is available, the Society says, “Patients should be made aware of the potential risk of cardiovascular events in middle-aged and older men who are taking or considering testosterone therapy. … Physicians and patients should have a conversation about the risks and benefits … especially in patients who have pre-existing heart disease.”

The statement recommends that any prescriptions for testosterone be given in accordance with the Society’s practice guidelines (see link below).

Link(s):

Endocrine Society’s statement (Free PDF) : The Risk of Cardiovascular Events in Men Receiving Testosterone Therapy: An Endocrine Society Statement, February 7, 2014

Endocrine Society’s clinical practice guideline on testosterone therapy (Free PDF) 

Background: Physician’s First Watch coverage of PLoS ONE study (Free)

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Treatment key to living with metastatic bone cancer

By Sheryl M. Ness, R.N. February 12, 2014

This week, I’d like to discuss a complication that can occur with advanced cancer that many of you may be unaware of. Bone metastasis occurs when cancer cells spread from their original site to a location in the bone. The most common types of cancer more likely to spread to bone include breast, prostate and lung cancer.

Full article: click here

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MOVING THE DIAL TO CURE; CAN TARGETED RADIOTHERAPY ACTUALLY ERADICATE TUMORS IN MEN WITH ADVANCED PROSTATE CANCER?

Until recently radiation therapy for advanced prostate cancer was only used to alleviate pain; now it has been shown to extend life, and a novel radio-immunotherapeutic drug in development may actually bring about a cure in some men. Promising Phase II clinical study results of novel radio-immunotherapeutic 177Lu-J591; new trial opening for men with micro-metastatic disease.

Full article: Click here.

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Cancer diagnosis: 11 tips for coping

If you’ve been diagnosed with cancer, knowing what to expect and making plans for how to proceed can help make this stressful time easier. By Mayo Clinic Staff

Learning that you have cancer is a difficult experience. After your cancer diagnosis, you may feel anxious, afraid or overwhelmed and wonder how you can cope during the days ahead. Here are 11 suggestions for coping with a cancer diagnosis.

Full article: Click here.

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Johns Hopkins Health Alerts, Wed, 12 Feb 2014 11:02:44

Latest Research of PSA Velocity as a Predictor of Prostate Cancer

Clinical studies involving carefully selected groups of men have indicated that measuring PSA velocity — that is, the rate at which prostate-specific antigen (PSA) levels rise over time — is a more accurate predictor of whether a man may have prostate cancer (and require a biopsy) than the results of a single PSA test.

To test this theory in a “real world” setting, researchers tracked 219,388 men who were members of the Kaiser Permanente health plan in southern California from 1998 to 2008. On average, each man had five PSA tests during that period.

By the end of the study period, 10,035 men had developed prostate cancer. PSA velocity accurately predicted which men would develop prostate cancer and was significantly more accurate than a single PSA measurement in predicting which men would develop aggressive disease.

Takeaway message. Current guidelines recommend against using results from a single PSA screening test to diagnose prostate cancer. Nevertheless, these findings offer strong evidence that PSA velocity provides additional useful information that could impact management decisions.

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Johns Hopkins Health Alerts, 2/6/2014

Can Drinking Coffee Reduce the Risk of Prostate Cancer?

Here’s What We Know

After water and tea, the most popular beverage in the world is coffee. While it tastes great, and the caffeine provides a jolt to get you moving, coffee also appears to offer numerous health benefits. Here’s an excerpt from a recent Prostate Disorders Bulletin that sheds light on this interesting topic.

Over the years, epidemiological studies have looked at daily coffee consumption to determine its impact on a person’s overall health. Coffee beans contain many naturally occurring compounds, including polyphenols, antioxidant substances that are potentially health-enhancing.

Caffeine, a mild psychoactive substance that stimulates the central nervous system, has properties that inhibit cell growth and encourage apoptosis, or programmed cell death. Previous studies have reported that caffeine consumption in a variety of drinks may reduce the risk of several types of cancer, including basal-cell carcinoma, glioma (a cancer of the brain and central nervous system) and ovarian cancer.

A study published recently in Nutrition Journal found a reduced risk of aggressive prostate cancer in coffee drinkers. This confirms the 2011 Journal of the National Cancer Institute study by Harvard researchers, which reported that men who regularly consumed the most coffee had a 60 percent lower lower risk of advanced or lethal prostate cancer compared with non-coffee drinkers. Even one to three cups a day afforded a 30 percent lower risk.

And now, according to a new study by scientists from Seattle’s Fred Hutchinson Cancer Research Center, published in the journal Cancer Causes and Control, coffee consumption is associated with a lower risk of prostate cancer recurrence and progression.

The researchers, led by Janet L. Stanford, Ph.D., co-director of the Program in Prostate Cancer Research, found that men who drank four or more cups of coffee per day experienced a 59 percent reduced risk of prostate cancer recurrence and/or progression as compared to those who drank only one cup or less per week.

The bottom line on coffee and prostate cancer. There certainly seems to be an association between daily coffee consumption and a reduction in the risk for diagnosis, disease progression and death from prostate cancer. However, based on the results of the various coffee studies published to date, there is still not enough information to recommend that anyone start drinking coffee solely for its potential anti-cancer benefits. Remember that all the studies we have are observational, and these research efforts do not prove any clear cause-and-effect relationship between coffee consumption and prostate cancer protection.

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Walter Reed Prostate Cancer Support Group Newsletter.

Link to full article: http://www.cpdr.org/patient-information/ustoo/0214.pdf

Topics include:

  • Top Clinical Cancer Advances During 2013 (pages 1 and 17)
  • Inherited Risk of Prostate Cancer
  • Prostate Cancer Death Risk and Diabetics
  • Low Fat Diet, Omega-3 and Prostate Cancer
  • Inflammation at Biopsy and Prostate Cancer Risk
  • Surgical Anesthesia and Prostate Cancer (‘post-surgery opioids, which affect the whole body, may decrease the immune system effectiveness”)
  • Metastatic Prostate Cancer and Chemotherapy
  • New Radiation Therapy Prolongs Prostate Cancer Survival (Xofigo)
  • “The Prostate Cancer Controversy: What Patients Should Understand”

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Moving the Dial to Cure

A novel radioimmunotherapy drug that works like a smart bomb—fiinding and targeting tiny sites of prostate cancer spread—is noww in Phase II clinical trials; early results show very promising responses in patients. Read more about which men are most likely to benefit.

* Full Story – click here

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Custom-Fit Treatments for Prostate Cancer: Disease fight takes a page out of the breast-cancer approach

By RON WINSLOW, Wall Street Journal

Jan. 13, 2014 7:12 p.m. ET
In a bid to improve treatment for men with high-risk prostate cancer, some researchers want to take a page from the playbook for breast cancer.Medical scientists are working to develop strategies for treating prostate tumors that are tailored to individual patients, as is currently done for many women with breast cancer. Fresh advances in the understanding of prostate cancer suggest that some men with a high-risk form of the disease might benefit from more aggressive treatment.

 

Click here for link to full article.

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Mayo Clinic Living with Cancer Blog

Click here for link.

Feb. 9, 2013

Sleep essential for healthy living: Get your 7 hours a night

By Sheryl M. Ness, R.N.

Did you get seven hours of sleep last night? Did you know that adults need 7-9 hours of sleep to stay healthy every night? Most people get far less than this on average, and the lack of sleep can take a toll on your body and mind.

As a cancer survivor, getting enough sleep can help your body respond better to treatment and may speed your recovery. It may also help you stay well if you’re exposed to other viruses, such as colds and the flu.

Researchers have discovered that during sleep, your immune system releases proteins called cytokines which can help you deal with stress, fight infections and decrease inflammation in the body. When you don’t get enough sleep, these protective proteins and other important infection-fighting cells are reduced.

Your body needs adequate sleep to fight infections and inflammation. Long-term lack of sleep can not only put you at risk for a weaker immune system, but can also increase your risk for other chronic conditions such as obesity, diabetes and heart disease.

Lack of sleep can also affect your mind. Sleep helps you rest your mind and prepare for a new day of activity, memories and experiences. If you’re not able to sleep well on a regular basis, you may find that you have trouble with memory and concentration. You may also have more anxiety and low emotions.

So, it’s important for both your body and your mind to get your zzz’s. Mayo Clinic experts recommend 7 steps to healthy sleep, which include:

  • Be consistent with your sleep schedule
  • Pay attention to what you eat and drink before bedtime
  • Create a bedtime routine
  • Be comfortable for sleeping
  • Limit napping during the day
  • Get some physical activity every day
  • Manage your stress

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Understanding the TNM Prostate Cancer Staging System ( Johns Hopkins Health Alerts)

Determining the extent of prostate cancer is important for predicting the course of the disease and in choosing the best treatment. The Whitemore-Jewett method or, more commonly the TNM (tumor, nodes, metastasis) staging system is used to describe a cancer’s clinical stage, or how far it has spread. This Health Alert provides an explanation of this important prostate cancer staging system.

The TNM system assigns a T number (T1 to T4) to describe the extent of the tumor as felt during a digital rectal exam (DRE). The N number (N0 to N1) indicates whether the cancer has spread to any lymph nodes, and the M number (M0 to M1) indicates the presence or absence of metastasis (spread to distant sites). The T and M designations are divided into subcategories (designated a, b and c) that provide further detail on the extent of the cancer.

The TNM clinical stage is used to help determine appropriate prostate cancer treatment options. Here’s a description of this important staging system:

  • T1: Tumor cannot be felt during DRE or seen with diagnostic imaging
  • T1a: Tumor found incidentally during surgery for benign prostatic hyperplasia (BPH) and is present in less than 5 percent of removed tissue
  • T1b: Tumor found incidentally during BPH surgery but involves more than 5 percent of removed tissue
  • T1c: Tumor found during needle biopsy for elevated prostate-specific antigen (PSA) levels
  • T2: Tumor can be felt during DRE but is believed to be confined to the gland
  • T2a: Tumor involves one-half or less of one side of the prostate
  • T2b: Tumor involves more than one-half of one side but not both sides
  • T2c: Tumor involves both sides of the prostate
  • T3: Tumor extends through the prostate capsule and may involve the seminal vesicles
  • T3a: Tumor extends through the capsule but does not involve the seminal vesicles
  • T3b: Tumor has spread to the seminal vesicles
  • T4: Tumor has invaded adjacent structures (other than the seminal vesicles), such as the bladder neck, rectum or pelvic wall
  • NO: Cancer has not spread to any lymph nodes
  • N1: Cancer has spread to one or more regional lymph nodes (nodes in the pelvic region)
  • MO: No distant metastasis
  • M1: Distant metastasis
  • M1a: Cancer has spread to distant lymph nodes
  • M1b: Cancer has spread to the bones
  • M1c: Cancer has spread to other organs, with or without bone involvement

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New studies coming soon

  1.  Alpharaden (Xofigo)– this is a new intravenous drug for men whose prostate cancer has spread to the bones. We will start enrolling patients to this study in the March time frame. For more information, please call Ms Judi Travis at 301-319-2927. (Note: This drug is also available for qualified individuals without being on protocol).
  2.  Galeterone – this is a new oral drug, an androgen receptor blocker, for men whose prostate cancer is resistant to hormone therapy. We will start enrolling patients to this study in the February time frame.

For more information, please call Ms Judi Travis at 301-319-2927.

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Early Docetaxel Plus Androgen-Deprivation Therapy Improves Survival in Metastatic Prostate Cancer

By Kelly Young

The early addition of the chemotherapy drug docetaxel to androgen-deprivation therapy is associated with increased survival among patients with metastatic prostate cancer, compared with ADT alone, according to interim results released early by the National Institutes of Health because of their “practice-changing” implications.

Nearly 800 men with metastatic prostate cancer were randomized to ADT alone or ADT plus docetaxel every 3 weeks for 18 weeks. Three-year survival rates were significantly higher in the chemotherapy group (69% vs. 53% in ADT alone). Patients whose cancer had spread to major organs or had four or more bone lesions accounted for most of the observed benefit.

Oncologist Robert Dreicer with NEJM Journal Watch comments: “Data provided from this interim analysis suggests that men with very poor risk — i.e., extensive disease burden — may benefit the most from this approach.

Full data will be presented at an upcoming scientific meeting. This data will likely alter the management of some patients presenting with metastatic prostate cancer.”

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International Prostate Cancer Screening Recommendations Recognize Importance of PSA Testing

Recent prostate cancer screening recommendations from the US Preventive Services Task Force (USPSTF) and the American Urological Association (AUA) suggested that PSA testing for prostate cancer should be restricted in certain age groups or stopped altogether, resulting in confusion regarding the role of PSA testing in the early detection of prostate cancer. Consequently, many primary care physicians and internists are no longer ordering routine PSA tests in their patients.

New International Guidelines

The latest screening recommendations released by experts at the Prostate Cancer World Congress and the European Association of Urology (EAU) offered a different perspective. They emphasized that early detection reduces the number of men dying from prostate cancer and developing metastatic disease, and PSA testing is a key element of screening.

Melbourne Consensus Statement

Experts at the Prostate Cancer World Congress in Melbourne, Australia, created a consensus statement on PSA testing to address the conflicting recommendations of various urological groups. The statement highlighted the importance of shared decision-making and the significant improvement in prostate cancer survival rates since the introduction of PSA testing 20 years ago. The authors wrote that an important goal for early detection is to maintain these survival rate gains while minimizing the harms associated with overdiagnosis and overtreatment.

New EAU Guidelines

The updated EAU guidelines emphasized early detection of prostate cancer through an individualized, riskadapted approach rather than widespread mass screening. Baseline PSA testing is an integral component of the guidelines, as is identifying relevant risk factors that can be used to classify patients into risk groups.

“Abandonment of PSA testing as recommended by the USPSTF, would lead to a large increase in men presenting with advanced prostate cancer and a reversal of the gains made in prostate cancer mortality over the past three decades.”

–Melbourne Consensus Statement

Summaries:

Melbourne Consensus Statement

  • PSA testing for men ages 50-69 reduces deaths and frequency of metastatic prostate cancer
  • The authors recommend shared decision-making rather than routine population-based screening.
  • Prostate cancer diagnosis needs to be uncoupled from treatment
  • Active surveillance strategies need to be standardized and validated internationally to ensure the safety of this treatment approach.
  • PSA testing is part of the approach to early detection
  • Variables such as digital rectal examinations, prostate volume, family history, ethnicity and risk prediction models can help determine a man’s risk level. New tools such as the prostate health index (PHI) test and further developments of biomarkers may also enhance risk prediction.
  • A baseline PSA is useful for predicting future risk of prostate cancer
  • The higher a man’s baseline is above the median (0.5–0.7 ng/ml at 40- 49 years), the greater his risk of later developing life-threatening prostate cancer.
  • Men with a life expectancy of more than 10 years may still benefit from PSA testing
  • Individualized assessment, rather than age alone, should determine if PSA testing for an older man would be useful.
  • The Melbourne Consensus Statement was published online by BJU International. Dr. Catalona is a signatory on the statement.

EAU Guidelines

  • Early detection reduces prostate cancer deaths and the risk of being diagnosed with metastatic and advanced prostate cancer
  • A baseline PSA should be obtained at 40-45 years of age
  • A baseline PSA above the median might be a better indicator of prostate cancer development than other risk factors, such as race and family history.
  • Testing intervals should be adjusted according to the baseline PSA
  • Men with a PSA above 1.0 ug/l at 45–59 years of age should be screened every 2-4 years. Men with a PSA below this level could have a screening interval up to 8 years.
  • PSA screening should be offered to men with a life expectancy of 10 or more years
  • A man’s life expectancy, rather than his age, should be considered when discussing prostate cancer screening or treatment.
  • In the future, risk-prediction tools need to be part of the decision-making process
  • Multivariable risk-prediction tools such as risk calculators, clinical parameters such as new serum or urinary biomarkers, and the identification of specific genetic mutations associated with prostate cancer could help identify high-risk patients.
  • The guidelines were published by European Urology in June.

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BPA Exposure Linked to Prostate Cancer

Exposure to low levels of bisphenol A during development may make men more susceptible to prostate cancer later in life, according to a new study

By Brian Bienkowski and Environmental Health News

<http://www.scientificamerican.com/article.cfm?id=bpa-exposure-linked-to-prostate-cancer&gt;

Exposure to low levels of bisphenol A during development may make men more susceptible to prostate cancer later in life, according to a new study published Tuesday.

The study, which uses a new model of implanting human stem cells into mice, is the first to link early-life BPA exposure to human prostate cancer. It adds to a growing body of research that suggests exposure to low doses of the chemical alters cells and can lead to diseases later in life.

“Overall I think this is some of the strongest and most convincing evidence to date linking early-life BPA exposure and cancer,” said Heather Patisaul, a researcher at North Carolina State University who was not involved in the study. “They were careful to make the exposures human relevant, used cells derived from healthy humans and replicated physiological conditions seen in aging men.”

Prostate cancer is the second leading cause of cancer-related death in U.S. men. About 15 percent of men will be diagnosed with prostate cancer in their lifetime, according to the National Cancer Institute.

BPA is used to make polycarbonate plastics and is found in in some paper receipts, liners of some food cans and dental sealants. More than 90 percent of Americans have traces in their bodies and previous studies suggest there is “universal fetal exposure.”

Researchers led by a team from the University of Illinois at Chicago implanted prostate stem cells from deceased young men into mice. When the mice were fed BPA by mouth for the first two weeks of life, 33 percent of the stem cells had cancerous or precancerous lesions later in life. Forty-five percent of the cells that were exposed to BPA before and after mice implantation developed precancerous or cancerous lesions later. In comparison, only twelve percent of the mice not exposed to BPA during development had cancer or precancerous lesions later in life.

BPA acts as an estrogen and previous research has linked elevated estrogen levels during pregnancy to increased risk of prostate cancer in males.

“We know that stem cells help replenish our organs throughout life. We propose that if there is exposure early in life to an estrogenic compound – such as BPA – it reprograms our stem cells,” said Gail Prins, a University of Illinois at Chicago researcher and lead author of the study, which was published in the journal Endocrinology.

Although the cells were from deceased adults, by using regenerative stem cells that produce prostate tissues, the researchers said they were able to simulate developmental exposure. It is the latest addition to a growing body of research – called epigenetics – that has linked some chemicals to altered DNA sequencing in fetuses that can lead to diseases later in life.

Patisaul said the new model cannot “perfectly replicate human physiology,” but is advantageous because they’re exploring “the impact of BPA … on human cells in a whole animal instead of a dish.”

However, a representative of the chemical industry said that the model of implanting the stem cells into mice has not been established to be valid. The study has “very limited relevance to real-life human exposures to BPA,” Steve Hentges, a representative of the American Chemistry Council, said in a prepared statement.

“The [BPA] levels tested are more than 1,000 times higher than typical human exposures,” he said.

Prins said “that’s just not true.”

“Twenty minutes after exposure the levels of BPA measured in the blood of the animals that were the hosts bearing the transplants were exactly what we’re seeing measured in the umbilical cord fluid of women,” Prins said, citing a 2013 study on California women.

In addition to the BPA, all the mice were given an estrogen to simulate human male aging. As men age their estrogen levels rise.

Men’s rising levels of estrogen are at least partly responsible for prostate cancer. Prins said the early-life exposure to BPA is sensitizing the prostate stem cells to estrogen, and the stem cells pass along this estrogen sensitivity to prostate tissues later in life.

Prins’ earlier work found that rats exposed to BPA at human-relevant doses had adult prostates that were more sensitive to developing cancer.

Also, developmental BPA exposure was linked to breast cancer in rats last year by Tufts University researchers, but the data did not reach statistical significance, said Nicole Acevedo, a postdoctoral researcher at Tufts University and lead author of the study. Some rats exposed to low doses of BPA developed malignant tumors while none of the non-exposed did.*

This article originally ran at Environmental Health News, a news source published by Environmental Health Sciences, a nonprofit media company.

* Editor’s Note (1/8/14): This sentence has been changed to clarify how many rats developed tumors and of what kind.

__________________________

November 19, 2013

Men treated with hormone therapy for advanced prostate cancer are at high risk for developing osteoporosis — fragile bones due to loss of bone mineral density. Men’s bones may actually take a double hit because prostate cancer tends to spread to the bones and weaken them. When that happens, the prostate cancer is typically treated with androgen-deprivation therapy, which further contributes to bone loss because androgens help maintain bone density in men.

Research suggests that men can lose 2 to 6 percent of their bone mineral density in the first year of androgen-deprivation therapy for prostate cancer. Bone loss continues in the second year but at a much slower rate. Bone loss can result in painful fractures and falls, loss of ability and independence and a reduced quality of life.

To detect osteoporosis early, men with advanced prostate cancer should undergo regular bone-density screening with dual-energy X-ray absorptiometry (DEXA) scanning.

Fight back to strengthen bones. Effective medications are available to strengthen and protect bones. First-line therapy is usually a bisphosphonate, such as alendronate (Fosamax) or zoledronic acid (Reclast), which slows the breakdown of bone. Some men may benefit from a selective estrogen receptor modulator (SERM), including raloxifene (Evista) or toremifene (Fareston). These drugs stimulate bone building and shut down the activity of osteoclasts, which destroy bone.

Finally, a promising new drug called denosumab (Prolia) blocks the formation of a protein that causes bone to break down. A study in The New England Journal of Medicine found that Prolia reduced the risk of vertebral fractures by 62 percent.

 

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