Status:
COMPLETED
Role of Soy Supplementation in Prostate Cancer Development
Lead Sponsor:
VA Office of Research and Development
Conditions:
Prostate Neoplasm
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 pl...
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 p...
Eligibility Criteria
Inclusion
- Histologically proven prostate cancer.
- Surgical candidate for prostatectomy.
- During study period, must agree not to take new supplements.
- No concurrent chemotherapy, radiation or hormonal therapy.
- No history of prior allergy to soy based products.
- Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment.
- Must be able to safely be on study supplements for period of at least two weeks prior to scheduled prostatectomy.
- Must give written and informed consent in accordance with institutional and federal guidelines.
Exclusion
- During study period, must agree not to take new supplements.
- No concurrent chemotherapy, radiation or hormonal therapy.
- No history of prior allergy to soy based products.
- Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment.
- Must be able to safely be on study supplements for period of at least two weeks prior to scheduled
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00255125
Start Date
September 1 2005
End Date
October 1 2009
Last Update
June 18 2019
Active Locations (1)
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1
VA Medical Center, Kansas City MO
Kansas City, Missouri, United States, 64128