Spots Global Cancer Trial Database for Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels
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Trial Identification
Brief Title: Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels
Official Title: Effects of Dietary Soy on Biomarkers of Prostate Cancer: A Prospective Phase II Study
Study ID: NCT00031746
Conditions
Study Description
Brief Summary: 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.
Detailed Description: OBJECTIVES: * 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.
Keywords
Eligibility
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Walter Reed Army Medical Center, Washington, District of Columbia, United States
CCOP - Hematology-Oncology Associates of Central New York, Syracuse, New York, United States
Community General Hospital of Greater Syracuse, Syracuse, New York, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, United States
Contact Details
Name: James L. Mohler, MD
Affiliation: Roswell Park Cancer Institute
Role: STUDY_CHAIR
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