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Keep this study
Lead
VA Office of Research and Development
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.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | Role of Soy Supplementation in Prostate Cancer Development