NCT00255125

Role of Soy Supplementation in Prostate Cancer Development

Role of Soy Isoflavones in Prostate Cancer Prevention

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized study evaluating the effectiveness and direct effect a commercial soy supplement has on prostate cancer and normal prostate tissue. Patient will be randomized it either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned surgery for treatment of their prostate cancer. Patient's blood and prostate tissue will be evaluated to determine the effects of the soy supplement on the prostate tissue.

Detailed description

This is a randomized study evaluating the effectiveness and direct effect a commercial soy supplement has on prostate cancer and normal prostate tissue. Patients will be randomized to either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned surgery for treatment of their prostate cancer. The specific objectives are: 1. To assess the effect of soy supplementation on endogenous hormone production levels and serum prostate specific antigens. 2. To assess the impact of soy supplementation on estrogen receptor expression(ER). 3. To determine the impact of soy isoflavones on cell cycle regulation and associated gene expression.

Conditions

• Prostate Neoplasm

Interventions

Type	Name	Description
DRUG	Soy Supplement	Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice).
DRUG	Placebo	Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice).

Timeline

• Start date: 2005-09-01
• Primary completion: 2009-04-01
• Completion: 2009-10-01
• First posted: 2005-11-17
• Last updated: 2019-06-18
• Results posted: 2015-06-17

Locations

1 site across 1 country: United States