Isoflavones & Lycopene in Localized Prostate Ca:Prior to Radical Prostatectomy
Prostate Cancer
About this trial
This is an interventional supportive care trial for Prostate Cancer focused on measuring stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed localized prostate cancer Stage I or II Scheduled prostatectomy between 4-6 weeks after initial biopsy PATIENT CHARACTERISTICS: Age: 45 to 80 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No known history of hepatic disease Renal: No known history of renal disease Other: No known history of thyroid disease Body mass index no greater than 32 Omnivorous diet No known allergy to study supplements No evidence of prostatitis or urinary tract infection No other prior malignancy except nonmelanoma skin cancer Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent thyroid hormone replacement medications Radiotherapy: Not specified Surgery: See Disease Characteristics Other: At least 30 days since prior antibiotics At least 30 days since prior diet high in soy and/or lycopene products (e.g., greater than 40 mg soy/day and/or greater than 15 mg lycopene/day) No other concurrent nutritional supplements, including modular supplements with other carotenoids and isoflavones No prior or concurrent therapy for prostate cancer
Sites / Locations
- CCOP - Western Regional, Arizona
- H. Lee Moffitt Cancer Center and Research Institute
- Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
- CCOP - MeritCare Hospital
- CCOP - Scott and White Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Oral isoflavones with multivitamin
Oral lycopene with multivitamin
Multiple vitamin alone
Cohorts I - III: Patients receive 1 of 3 doses of oral isoflavones twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy.
Cohorts IV-VI: Patients receive 1 of 3 doses of oral lycopene twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy.
Patients receive a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy.