A Pilot Study of the Supplementation of Genistein Concentrated Polysaccharide, GCP™, in men with Prostate Cancer before Radical Retropubic Prostatectomy.

Principal Investigator:

Aaron E. Katz, M.D.
Assistant Professor of Urology
College of Physicians and Surgeons
Department of Urology
Columbia University
(212) 305-6408

Study Purpose: This study will examine the physiological effects of Genistein Concentrated Polysaccharide (GCP™) supplementation in men diagnosed with prostate cancer who will undergo radical surgery. The study will investigate whether the ingestion of GCP induces cell death or a reduction in the blood vessels within the prostate gland using tissue markers of angiogenesis such as CD31. In addition, we will determine if there is a change in the serum and urine levels of genistein following GCP ingestion. Since this is a pilot investigation, an additional objective of the study is to determine the toxicity profile of GCP.

GCP™ is a nutritional supplement made by the Amino Up Chemical Company in Sapporo, Japan.  It is a mixture of a mushroom and soybean extract.  Research on GCP™ has shown it can reduce prostate cancer cell growth and the formation of blood vessels in prostate tumors. 

Study subjects and method of recruitment:

Men who have been diagnosed with prostate cancer who will be undergoing radical surgery for primary treatment of prostate cancer in the Department of Urology will be eligible for this study. 

Study procedures: Prior to study participation, all patients will sign an informed consent.  At baseline and at 6 weeks, patients will have a PSA (prostate specific antigen), liver function test, CBC, Chem 7, and 24 hour urine and blood analysis for genistein content.  At baseline and 6 weeks, they will also complete a side effect profile questionnaire.   At baseline, prostate biopsy tissue will be tested for levels and expression of bcl2, CD31, and p27.  For the PSA, toxicity tests, and blood genistein test, 5 ml of blood (approximately 1 teaspoon) will be taken from study participants.  Patients will take GCP™ prior to surgery.  Upon pathological diagnosis post radical surgery, prostate tissue will be evaluated for the genistein level, bcl-2,  CD31, and p27.