Role of Soy Supplementation in Prostate Cancer Development

VA Office of Research and Development

Status and phase: Completed; Phase 3

Conditions: Prostate Neoplasm

Treatments: Drug: Placebo; Drug: Soy Supplement

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00255125

CLIN-006-05S

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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86 participants in 2 patient groups, including a placebo group

Arm Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Arm Soy Supplement

Experimental group

Description:

Soy Supplement

Treatment:

Drug: Soy Supplement