RATIONALE: Dietary supplementation with soy may keep prostate cancer from growing in patients planning to undergo surgery. PURPOSE: This randomized phase II trial is studying a soy supplement to see how well it works compared to a placebo in treating patients undergoing surgery for localized prostate cancer.
OBJECTIVES: Primary * Compare the effect of dietary supplementation with soy vs placebo on biomarkers of cell cycle regulation, proliferation, differentiation, apoptosis, and signaling pathways in patients with localized prostate cancer scheduled to undergo radical prostatectomy. Secondary * Compare the toxicity and side effects of these regimens in these patients. * Compare the dietary patterns of these patients. OUTLINE: This is a prospective, randomized study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral soy supplementation daily for 4 weeks. * Arm II: Patients receive oral placebo supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy or placebo supplementation. Blood and tissue samples are collected for biomarker analysis using immunohistochemistry.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
Given orally
Given orally
Given orally
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Correlation of pretreatment ER-β expression with response to soy supplementation
after a 4 week therapy, within 21 days, a Radical Prostatectomy will be performed, and after that ER-β expression will be measured.
Time frame: within 21 days after completetion of supplement regimen
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.