Role of Soy Supplementation in Prostate Cancer Development - Full Text View

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00255125

Purpose

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.

Condition	Intervention	Phase
Prostate Neoplasm	Drug: Soy Supplement Drug: Placebo	Phase III

MedlinePlus related topics: Cancer Dietary Supplements Prostate Cancer

Drug Information available for: Proteins, soy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Role of Soy Isoflavones in Prostate Cancer Prevention

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

1.Effect of Soy Isoflavones on serum hormonal serum levels. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

2.Effect of Soy Isoflavones on estrogen receptor status. [ Time Frame: One year ] [ Designated as safety issue: No ]
Molecular Effects of Soy Isoflavones. [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment:	86
Study Start Date:	September 2005
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo	Drug: Soy Supplement Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice).
2: Experimental Soy Supplement	Drug: Placebo Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice).

Detailed Description:

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:

To assess the effect of soy supplementation on endogenous hormone production levels and serum prostate specific antigens.
To assess the impact of soy supplementation on estrogen receptor expression(ER).
To determine the impact of soy isoflavones on cell cycle regulation and associated gene expression.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255125

Contacts

Contact: Peter Vanveldhuizen, MD

peter.vanveldhuizen@va.gov

Locations

United States, Missouri
VA Medical Center, Kansas City MO	Recruiting
Kansas City, Missouri, United States, 64128
Contact: Peter Vanveldhuizen, MD peter.vanveldhuizen@va.gov
Principal Investigator: Peter Vanveldhuizen, MD

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Peter Vanveldhuizen, MD

VA Medical Center, Kansas City MO

More Information

Responsible Party:	Department of Veterans Affairs ( Vanveldhuizen, Peter - Principal Investigator )
Study ID Numbers:	CLIN-006-05S
Study First Received:	November 15, 2005
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00255125
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Estrogen Receptor
Isoflavones
Prostate Neoplasm
Soy Supplementation

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009