Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate
Prostate Cancer
About this trial
This is an interventional prevention trial for Prostate Cancer focused on measuring stage I prostate cancer, stage II prostate cancer, adenocarcinoma of the prostate
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Stage T1c or T2 Disease confined to the prostate gland Planning to undergo radical prostatectomy within the next 3-4 weeks PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic ALT and AST less than 2 times upper limit of normal (ULN) Alkaline phosphatase less than 2 times ULN Renal Not specified Other Fertile patients must use effective barrier contraception Medically cleared for surgery No concurrent thyroid disease PRIOR CONCURRENT THERAPY: Biologic therapy No prior biological therapy for prostate cancer No concurrent biological agents Chemotherapy No prior chemotherapy for prostate cancer No concurrent chemotherapy Endocrine therapy No prior hormonal therapy for prostate cancer No concurrent thyroid hormone replacement medication No concurrent hormonal therapy Radiotherapy Not specified Surgery See Disease Characteristics Other At least 3 months since prior high-dose nutritional supplements No concurrent regular use (more than once weekly) of soy products greater than 50 g of soy protein or 50 mg of soy isoflavone No concurrent high-dose nutritional supplements Standard-dose single multivitamin tablet (e.g., Centrum™) allowed No concurrent herbs No concurrent soy foods No other concurrent isoflavone supplements No other concurrent antineoplastic agents
Sites / Locations
- Barbara Ann Karmanos Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Placebo
Soy isoflavones and placebo
Soy Isoflavones/Placebo
Soy Isoflavones
Arm I (control group): Patients receive 4 placebo capsules by mouth daily for three weeks.
Arm II: Patients receive oral soy isoflavones (PTI G-2535) 150 mg genistein capsules + 3 placebo capsules by mouth daily for 3 weeks.
Arm III: Patients receive oral soy isoflavones (PTI G-2535) 300 mg genistein capsules + 2 placebo capsules by mouth daily for 3 weeks.
Arm IV: Arm III: Patients receive oral soy isoflavones (PTI G-2535) 600 mg genistein capsules by mouth daily for 3 weeks.