Randomized Phase IIb Preprostatectomy Study of Dietary Supplementation With Soy and Biomarkers of Prostate Cancer Risk and Progression
- 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.
- 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
- 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
Blood and tissue samples are collected for biomarker analysis using immunohistochemistry.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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.
within 21 days after completetion of supplement regimen
M. Craig Hall, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|