Issue 3 / April 2015

 

Welcome to another edition of the Peninsula Prostate Institute (PPI) Newsletter, covering a variety of prostate cancer topics. We are pleased to announce FDA approval of the SpaceOAR hydrogel. Peninsula Cancer Center in Poulsbo participated in the national clinical trial for this product and is excited about this major advancement in prostate cancer treatment. Feel free to forward this information to whomever you like. Thanks for your interest!

 

Sincerely,

 

R. Alex Hsi, MD

UPCOMING EVENTS
  

PPI Nutrition Class Spring 2015

Wednesday April 22, 2015 from 11:00 AM to 1:00 PM PDT

Please join us for our nutrition class focusing on prostate health. Class will be held every other Wednesday from 11:00 am to 1:00 pm through July 1st. You may register yourself and a guest.

Peninsula Cancer Center Conference Room.

 

IN THE NEWS

Update: SpaceOAR? Hydrogel Approved by FDA

  

On April 2, 2015, Augmenix, Inc. announced FDA clearance of its SpaceOAR? System, the first product in the United States cleared as a mechanism to protect the rectum in men undergoing radiation therapy for prostate cancer. The system utilizes a hydrogel that is administered through a small needle as a liquid, but quickly solidifies into a gel that expands the space between the rectum and prostate. By pushing the rectum away from the prostate, the radiation dose to normal rectal tissue can be greatly reduced. The gel is placed prior to the start of radiation therapy, remains stable throughout the treatment and then gets reabsorbed by the body within approximately 6 months. This same technology has been used safely in patients as a sealant and adhesion barrier for a number of years. Now prostate cancer patients will also benefit from this technology.  (See illustration and study image)

 

A clinical trial of the SpaceOAR? System was performed in 2012-2013.  The Peninsula Cancer Center was one of 20 sites across the United States that participated in this trial. Over 200 men were enrolled in the trial and randomized to either receive or not receive the hydrogel (in a 2:1 ratio). All patients then received external beam radiation therapy for their prostate cancer and were monitored for 15 months after their treatment. The results of the trial showed a 74% reduction in radiation dose to the rectum with a 75% reduction in acute rectal discomfort during treatment and a 71% reduction in long term rectal toxicity. After placement of the hydrogel, the average distance between the prostate and rectum increased from 1.6 millimeters to 12.6 millimeters. Although this difference of 11 millimeters sounds small, it makes a big difference in the radiation dose to the rectum. Results of this trial have been submitted to several peer-reviewed medical journals and are expected to be published later this year. Results will also be presented at major professional medical meetings this year including those sponsored by the American Urologic Association (AUA) and American Society for Radiation Oncology (ASTRO) and American Society for Clinical Oncology (ASCO).


According to John Pedersen, CEO of Augmenix, Inc., "FDA clearance of the SpaceOAR
? System represents a significant development in advancing the safety, precision and flexibility with which prostate cancer radiotherapy can be delivered."  Providers at Peninsula Cancer Center in Poulsbo will now focus on making this technology available to prostate cancer patients on the Kitsap and Olympic Peninsula in the coming months.

 

Bottom Line:  A significant new technology that will minimize side effects and increase the safety of radiation therapy for prostate cancer is now FDA approved and will be available to prostate cancer patients (at a cancer center near you!) in the very near future.

 

 

A Warning for Intermediate Risk Prostate Cancer Patients

on Active Surveillance

 

A recent study presented in February 2015 at the Genitourinary Cancers Symposium in Orlando, Florida calls into question the use of active surveillance in patients with intermediate risk prostate cancer.  Researchers were surprised to find that intermediate risk patients (PSA >10, Gleason score 7 or clinical stage T2b/T2c) using an active surveillance approach had a fourfold risk of dying of prostate cancer compared to those patients with low risk disease.
 

The prospective study from Sunnybrook Health Sciences Center in Toronto, Canada included 945 patients with low or intermediate risk prostate cancer managed with active surveillance from 1995 to 2013.  Within that group, 237 (23.9%) had intermediate-risk prostate cancer and 708 had low-risk prostate cancer.  The 10- and 15-year cancer-specific survival rates were 95.5% and 88.5% for the intermediate-risk cohort, and 98.2% and 96.3% for the low-risk patients (P = .006).  Furthermore, the risk of prostate cancer-specific death at 15 years was 3.75 times higher for intermediate-risk patients compared with low-risk patients at the same time point: 11.5% vs. 3.7%, respectively.
 

"We were surprised by the greater risk of prostate cancer death in the intermediate-risk patients assigned to active surveillance," stated senior author D. Andrew Loblaw, MD.  "Caution should be exercised if active surveillance were to be implemented for intermediate-risk patients," stated lead author Hima Bindu Musunuru, MD.  This finding does highlight the shortcomings of the classification system of prostate cancer that divides patients into low, intermediate and high risk groups.  This system is based on physical exam findings (T stage), Gleason score (prostate biopsy results) and PSA (blood tests).  Within each group, however, there is still a heterogeneous population of patients with cancers that may behave biologically quite differently.  Newer ways to differentiate these patients are needed to better predict their tumor's behavior.  Advances in genetic profiling technology and imaging techniques such as MRI scanning (more on these topics in future newsletters) may help in this effort. 
 

Bottom Line:  Active surveillance for patients with intermediate risk prostate cancer and a life expectancy of 10 or more years should be used with caution and active treatment options should be seriously considered.

 

 

 

Fish Oil Supplements - The Case is Getting Weaker
(Especially for Prostate Cancer Patients)

 

A recent article in the New York Times addressed the issue of efficacy of fish oil supplements in reducing the risk of heart attack and stroke. A scientific article published in 2014 in JAMA (Journal of the American Medical Association) Internal Medicine examined 18 randomized controlled clinical trials and 6 meta analyses published between 2005 and 2012 in high impact medical journals like the New England Journal of Medicine. Each of these studies looked at whether fish oil could prevent cardiovascular events in patients with a history of heart disease or those with strong risk factors for it like high cholesterol, high blood pressure or diabetes. All but two of the studies showed no benefit to fish oil compared to placebo. Yet during this same time period, the sales of fish oil supplements more than doubled worldwide. "There's a major disconnect," said Dr. Andrew Grey, associate professor of medicine at the University of Auckland in New Zealand and author of the study noting rising sales of supplements despite the progressive accumulation of trials that show no effect.
 

Theoretically, however, fish oil supplements should improve cardiovascular health because they contain omega-3 fatty acids which have blood thinning and anti inflammatory effects. But these effects have not translated into a benefit in large clinical trials over the past decade. Some scientists theorize that earlier studies that did show a benefit were done in an era of less advanced cardiac medications and technologies. Therefore, any benefit from fish oil is now negated by the improvement in current standard treatments for cardiac disease.  Another researcher at the Brigham and Women's Hospital in Boston, Dr. JoAnn Manson, notes that most of the current large studies were aimed at people who already have or are at high risk for developing heart disease. She is leading a trial of 26,000 people that is more representative of the general population with regard to their cardiovascular disease risk. The trial will be completed next year and will examine the effect of fish oil and Vitamin D (separate and combined) on the prevention of heart disease, diabetes and other diseases in people who do not have strong risk factors.

 
So if you are still reading and have reached this paragraph, you are probably wondering what all of this has to do with prostate cancer!  Well, as described in a previous newsletter of mine, there was a study from the Fred Hutchinson Cancer Center titled "Plasma Phospholipid Fatty Acids and Prostate Cancer Risk in the SELECT Trial" published in the Journal of the National Cancer Institute in July 2013 which found a link between omega-3 fatty acids and increased risk of developing both prostate cancer in general as well as high risk (more aggressive) prostate cancer. Although researchers expected to see a decrease in prostate cancer in those with high levels of omega-3 fatty acids in their blood, they actually found the opposite. Those with the highest omega-3 fatty acid blood levels had a 43% increased risk of developing prostate cancer and a 71% increased risk of developing high risk (the most aggressive form) prostate cancer.  However, this study does not specifically address the question, "Do higher levels of omega-3 fatty acids in those already diagnosed and treated for prostate cancer (which is the case for most of you reading this newsletter) increase the risk of recurrence of prostate cancer?"  These findings, however, still give me pause in prostate cancer patients who have gone through treatment and are now taking fish oil supplements. 

 

Bottom Line:  The New York Times article reinforces the fact that the jury is still out on the cardiovascular benefits of fish oil supplements and results from the SELECT trial point out the potential harm with regard to prostate cancer. 

 

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