Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels
RATIONALE: Soy protein supplement may prevent or delay the development of prostate cancer in patients who have elevated prostate-specific antigen (PSA) levels.
PURPOSE: Randomized phase II trial to determine the effectiveness of soy protein supplement in preventing prostate cancer in patients who have elevated PSA levels.
|Prostate Cancer||Dietary Supplement: soy protein isolate Dietary Supplement: casein proteins||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Prevention
|Official Title:||Effects of Dietary Soy on Biomarkers of Prostate Cancer: A Prospective Phase II Study|
- Reduction of prostatic cellular proliferation rates by 50% as measured by Ki-67 [ Time Frame: 12 months ]
|Study Start Date:||February 2000|
|Study Completion Date:||June 2006|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
|Active Comparator: soy protein + isoflavones||
Dietary Supplement: soy protein isolate
25 mg daily
|Active Comparator: casein proteins||
Dietary Supplement: casein proteins
25 mg daily
- Compare the reduction in the rate of prostatic cellular proliferation in patients with an elevated PSA (5 to 10 ng/mL) and a negative biopsy for prostate cancer when treated with daily soy protein supplements vs placebo.
- Compare the effect of these regimens on additional biomarkers of prostate cancer (PSA, high-grade prostate intraepithelial neoplasia, induction of apoptosis, sex steroid receptor expression, and loss of glutathione S-transferase-pi) in these patients.
- Compare the effect of these regimens on quality of life, including urinary and sexual function, in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to race (Caucasian vs African American). After 2 weeks of daily oral placebo, patients are randomized to 1 of 2 arms.
- Arm I: Patients receive oral soy protein supplement daily for 12 months.
- Arm II: Patients receive oral placebo daily for 12 months. Quality of life is assessed at baseline and at 6 and 12 months.
PROJECTED ACCRUAL: A total of 160 patients (80 per arm) will be accrued for this study within 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031746
|United States, District of Columbia|
|Walter Reed Army Medical Center|
|Washington, District of Columbia, United States, 20307-5001|
|United States, New York|
|CCOP - Hematology-Oncology Associates of Central New York|
|Syracuse, New York, United States, 13057|
|Community General Hospital of Greater Syracuse|
|Syracuse, New York, United States, 13215|
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University|
|Columbus, Ohio, United States, 43210-1240|
|Study Chair:||James L. Mohler, MD||Roswell Park Cancer Institute|