Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer
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.
|Prostate Cancer||Dietary Supplement: soy isoflavones Dietary Supplement: soy protein isolate Other: placebo|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
|Official Title:||Randomized Phase IIb Preprostatectomy Study of Dietary Supplementation With Soy and Biomarkers of Prostate Cancer Risk and Progression|
- Correlation of pretreatment ER-β expression with response to soy supplementation [ Time Frame: within 21 days after completetion of supplement regimen ]after a 4 week therapy, within 21 days, a Radical Prostatectomy will be performed, and after that ER-β expression will be measured.
|Study Start Date:||October 2003|
|Estimated Study Completion Date:||November 2017|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral soy supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy supplementation.
Dietary Supplement: soy isoflavones
Given orallyDietary Supplement: soy protein isolate
Placebo Comparator: Arm II
Patients receive oral placebo supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of placebo supplementation.
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345813
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||M. Craig Hall, MD||Wake Forest University Health Sciences|