Prostate Cancer Clinical Trial
Official title:
Effects of Dietary Soy on Biomarkers of Prostate Cancer: A Prospective Phase II Study
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
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