Role of Soy Supplementation in Prostate Cancer Development
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|ClinicalTrials.gov Identifier: NCT00255125|
Recruitment Status : Completed
First Posted : November 17, 2005
Results First Posted : June 17, 2015
Last Update Posted : June 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Prostate Neoplasm||Drug: Soy Supplement Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Role of Soy Isoflavones in Prostate Cancer Prevention|
|Study Start Date :||September 2005|
|Primary Completion Date :||April 2009|
|Study Completion Date :||October 2009|
Placebo Comparator: Arm 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
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
- 1.Effect of Soy Isoflavones on Serum Testosterone Levels. [ Time Frame: Two weeks ]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.
- 2.Effect of Soy Isoflavones on Estrogen Receptor Status. [ Time Frame: One year ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255125
|United States, Missouri|
|VA Medical Center, Kansas City MO|
|Kansas City, Missouri, United States, 64128|
|Principal Investigator:||Peter Vanveldhuizen, MD||VA Medical Center, Kansas City MO|