A Clinical Trial of Mushroom (PSK) for Treatment of Prostate Cancer

Project Overview

The NIH/NCCAM funded a clinical trial for prostate cancer patients at Bastyr University/University of Washington’s Mushroom Cancer Research Center. The purpose of the study is to test the safety and tolerability of consuming the mushroom supplement, and to detect the modulation of their immune functions in laboratory assays. The Center’s scientists chose a mushroom product that has been approved as a pharmaceutical drug in Japan—protein-bound polysaccharide K (PSK^®, Krestin^®). PSK has a long term (over 30 years) safety record and many positive results are indicated in uncontrolled trials. The design of this study is a double blind placebo, controlled for PSK, which is the gold standard for evidence-based medicine. All patients in this study will receive standard docetaxel chemotherapy treatment. The focus of our study is the safety and tolerability of PSK for metastatic and castration-resistant prostate cancer patients who are treated by docetaxel chemotherapy, and to recruit approximately 30 patients.

Participant criteria:

• Men with metastatic and castration-resistant prostate cancer who are suitable for docetaxel chemotherapy treatment
• Not allergic to mushroom products
• Willing to be randomized to PSK or Placebo group (3:1 ratio)
• Willing to take 3 to 12 grams a day of PSK based on assignment
• Have access to transportation to and from the Seattle Cancer Care Alliance

For healthcare providers and researchers, please refer the following link (clinicaltrials.gov):

http://www.clinicaltrials.gov/ct2/show/NCT01685489?term=psk+seattle&rank=1

How to participate

Recruitment is scheduled to begin in May or June 2013. In the meantime, please contact the person below to put your name on a waiting list. We will contact you for screening as soon as the trial opens.

Contact

To get on the recruitment list or if you have questions, please contact Dr. Masa Sasagawa (msasagawa[at]bastyr[dot]edu) at 425-602-3419. If you are already involved in this research study, any questions about your rights as a research subject should be directed to Dr. Liz Adams (liza[at]bastyr[dot]edu) at 425-602-3416 the Bastyr University Office of Research Integrity.