Prostate Cancer Clinical Trial
Official title:
Randomized Phase IIb Preprostatectomy Study of Dietary Supplementation With Soy and Biomarkers of Prostate Cancer Risk and Progression
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.
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