Effects of Dietary Soy on Biomarkers of Prostate Cancer: A Prospective Phase II Study
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Reduction of prostatic cellular proliferation rates by 50% as measured by Ki-67
James L. Mohler, MD
Roswell Park Cancer Institute
United States: Federal Government
|Walter Reed Army Medical Center||Washington, District of Columbia 20307-5000|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University||Columbus, Ohio 43210-1240|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|CCOP - Hematology-Oncology Associates of Central New York||East Syracuse, New York 13057|
|Community General Hospital of Greater Syracuse||Syracuse, New York 13215|