Back to resultsRole of Soy Supplementation in Prostate Cancer Development
Primary Purpose
Prostate Neoplasm
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Soy Supplement
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Neoplasm focused on measuring Estrogen Receptor, Isoflavones, Prostate Neoplasm, Soy Supplementation
Eligibility 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
Sites / Locations
- VA Medical Center, Kansas City MO
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Arm Placebo
Arm Soy Supplement
Arm Description
Placebo
Soy Supplement
Outcomes
Primary Outcome Measures
Effect of Soy Isoflavones on Serum Testosterone Levels.
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
Effect of Soy Isoflavones on Estrogen Receptor Status
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.
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.
Full Information
NCT ID
NCT00255125
First Posted
November 15, 2005
Last Updated
June 6, 2019
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT00255125
Brief Title
Role of Soy Supplementation in Prostate Cancer Development
Official Title
Role of Soy Isoflavones in Prostate Cancer Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Neoplasm
Keywords
Estrogen Receptor, Isoflavones, Prostate Neoplasm, Soy Supplementation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Arm Soy Supplement
Arm Type
Experimental
Arm Description
Soy Supplement
Intervention Type
Drug
Intervention Name(s)
Soy Supplement
Other Intervention Name(s)
Fla-vien
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
No other name
Intervention Description
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).
Primary Outcome Measure Information:
Title
Effect of Soy Isoflavones on Serum Testosterone Levels.
Description
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.
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Effect of Soy Isoflavones on Estrogen Receptor Status
Description
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.
Time Frame
Two weeks
Title
Molecular Effects of Soy Supplementation Compared to Placebo.
Description
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.
Time Frame
One year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Vanveldhuizen, MD
Organizational Affiliation
VA Medical Center, Kansas City MO
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Kansas City MO
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23874588
Citation
Hamilton-Reeves JM, Banerjee S, Banerjee SK, Holzbeierlein JM, Thrasher JB, Kambhampati S, Keighley J, Van Veldhuizen P. Short-term soy isoflavone intervention in patients with localized prostate cancer: a randomized, double-blind, placebo-controlled trial. PLoS One. 2013 Jul 12;8(7):e68331. doi: 10.1371/journal.pone.0068331. Print 2013.
Results Reference
result
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Role of Soy Supplementation in Prostate Cancer Development
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