Role of Soy Supplementation in Prostate Cancer Development

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00255125
First received: November 15, 2005
Last updated: June 12, 2015
Last verified: June 2015
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Role of Soy Isoflavones in Prostate Cancer Prevention

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 1.Effect of Soy Isoflavones on Serum Testosterone Levels. [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    Total testosterone (ng/ml) serum levels were measured at the time of enrollment(baseline), after two weeks on soy supplement(time point 1), and just prior to prostatectomy (time point 2). All patients must have completed at least two week of soy supplement or placebo and time point 3 varied depending on date of planned prostatectomy. Results were analyzed and are reported at the two week time period, comparing between patients receiving soy supplement or placebo.


Secondary Outcome Measures:
  • 2.Effect of Soy Isoflavones on Estrogen Receptor Status. [ Time Frame: One year ] [ Designated as safety issue: No ]
    Samples of the prostate cancer tissue (paraffin embedded) were sectioned and placed on a glass slide. Using immunohistochemistry and an estrogen receptor antibody, sections were stained and assess to determine the extent of estrogen receptor expression. Patients in the soy supplement arm's samples results were compared to placebo arm results.

  • Molecular Effects of Soy Supplementation Compared to Placebo. [ Time Frame: One year ] [ Designated as safety issue: No ]
    Using a tissue microarray targeting the cell cycle, selected fresh prostate cancer samples were evaluated in patients in the soy supplement arm compared to the placebo arm.


Enrollment: 86
Study Start Date: September 2005
Study Completion Date: October 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm Placebo
Placebo
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).
Other Name: No other name
Experimental: Arm Soy Supplement
Soy Supplement
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).
Other Name: Fla-vien

Detailed 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.
  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Missouri
VA Medical Center, Kansas City MO
Kansas City, Missouri, United States, 64128
Sponsors and Collaborators
Investigators
Principal Investigator: Peter Vanveldhuizen, MD VA Medical Center, Kansas City MO
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00255125     History of Changes
Obsolete Identifiers: NCT00285480
Other Study ID Numbers: CLIN-006-05S
Study First Received: November 15, 2005
Results First Received: December 24, 2013
Last Updated: June 12, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Estrogen Receptor
Isoflavones
Prostate Neoplasm
Soy Supplementation

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on July 05, 2015