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Therapeutic Areas: Oncology | Nephrology/Urology
Disease Category: Prostate Cancer

Trial Information

A Phase Ib of Mushroom Powder in Biochemically Recurrent Prostate Cancer

You have been asked to participate in this research study because you have prostate cancer that persists despite prior therapy with surgery and/or radiation, do not have evidence of metastatic disease and have chosen not to receive hormone therapy at this time. The purpose of this research study is to evaluate the safety and effectiveness of prolonged therapy with mushroom powder given in tablet forms at six different dose levels. Repeat blood samples will be taken at different time points to show how treatment with mushroom powder affects PSA level (blood marker of prostate cancer growth), the immune system and levels of various hormones that may have a role in prostate cancer growth. We will also collect blood samples to attempt to detect prostate cancer cells in the blood stream and to see if their numbers change after treatment with mushroom powder. Blood and urine samples will be collected to determine the levels of active ingredients of mushroom powder. Additional blood will be stored for future analysis. Your treatment on this study is expected to last for as long as your disease does not grow and you have no unmanageable side effects for up to one year. After you complete treatment, your medical condition will be followed indefinitely. 

II. BACKGROUND: It is well known that cancer patients have abnormalities in their immune system (the system in the body that protects from disease) and the amount of these abnormalities may be related to how cancer progresses. Research has shown that natural compounds found in certain mushrooms can enhance immune activity and can also result in changes in levels of various hormones that may be associated with the growth of prostate cancer. Research performed at the City of Hope showed that white button mushroom extract can slow down the growth of prostate cancer in the test tube and in experimental animals.

Patients who were previously treated with surgery and/or radiation and have evidence of early recurrence of prostate cancer based on increasing PSA marker are usually treated with hormonal therapy. Hormonal therapy is associated with significant side effects, such as fatigue, weight gain, muscle weakness, hot flashes, loss of libido, increased risk of diabetes and cardiovascular problems. Because of these side effects, and because hormone therapy is not a cure and there have been no studies showing that starting hormone therapy early rather than later changes overall survival, this study will treat subjects before they receive hormone therapy. This study is designed to test the safety of the natural compound mushroom powder and to determine the effects of mushroom powder therapy given at six different dose levels on PSA level and on various parameters of immune system and endocrine (hormonal) system.
 

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

City of Hope
1500 East Duarte Road
Duarte, CA 91010-3000
Phone: 866-896-HOPE (4673)

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