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Role of Soy Isoflavones in Prostate Cancer Prevention


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Neoplasm

Thank you

Trial Information

Role of Soy Isoflavones in Prostate Cancer Prevention


This is a randomized study evaluating the effetiveness and direct effect a commercial soy
suplement has on prostate cancer and normal prostate tissue. Patients will be randomized to
either receive placebo or a comercial 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.


Inclusion Criteria:



- Histologically proven prostate cancer.

- Surgical candidate for prostatectomy.

- During study period, must agree not to take new suplements.

- 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:

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

1.Effect of Soy Isoflavones on serum hormonal serum levels.

Outcome Time Frame:

One year

Safety Issue:

No

Principal Investigator

Peter Vanveldhuizen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

VA Medical Center, Kansas City MO

Authority:

United States: Federal Government

Study ID:

CLIN-006-05S

NCT ID:

NCT00255125

Start Date:

September 2005

Completion Date:

October 2009

Related Keywords:

  • Prostate Neoplasm
  • Estrogen Receptor
  • Isoflavones
  • Prostate Neoplasm
  • Soy Supplementation
  • Neoplasms
  • Prostatic Neoplasms

Name

Location
VA Medical Center, Kansas City MO Kansas City, Missouri  64128