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Role of Soy Supplementation in Prostate Cancer Development

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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