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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.
Age
18 - 120 years
Sex
MALE
Healthy Volunteers
No
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Start Date
October 1, 2003
Primary Completion Date
July 1, 2006
Completion Date
July 1, 2006
Last Updated
August 10, 2018
62
ACTUAL participants
soy isoflavones
DIETARY_SUPPLEMENT
soy protein isolate
DIETARY_SUPPLEMENT
placebo
OTHER
Lead Sponsor
Wake Forest University Health Sciences
Collaborators
NCT04550494
NCT06842498
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05691465