Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels
Prostate Cancer
About this trial
This is an interventional prevention trial for Prostate Cancer focused on measuring prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed absence of prostate cancer Atypical adenomatous hyperplasia or prostatic intraepithelial neoplasia (high-grade or low-grade) allowed Abnormal baseline transrectal ultrasound and digital rectal exam allowed Biopsy may be before or after study entry, but must be within the past 90 days PSA 5-10 ng/mL PATIENT CHARACTERISTICS: Age: 50 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No known allergy to soy protein or milk protein No invasive cancer within the past 5 years except non-melanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No prior hormonal therapy No prior finasteride No concurrent hormonal therapy No concurrent finasteride Radiotherapy: Not specified Surgery: At least 6 months since prior transurethral resection of the prostate No prior orchiectomy No concurrent orchiectomy Other: No other concurrent soy products
Sites / Locations
- Walter Reed Army Medical Center
- CCOP - Hematology-Oncology Associates of Central New York
- Community General Hospital of Greater Syracuse
- Wake Forest University Comprehensive Cancer Center
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
soy protein + isoflavones
casein proteins