Role of Soy Supplementation in Prostate Cancer Development

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development

Criteria

Inclusion Criteria:

• 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 Criteria:

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