Role of Soy Supplementation in Prostate Cancer Development

Study Overview
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Brief Summary
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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
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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.

Official Title
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Role of Soy Isoflavones in Prostate Cancer Prevention

Conditions
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Prostate Neoplasm

Intervention / Treatment
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* Drug: Soy Supplement
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm Placebo<br>Placebo | Drug: Placebo<br>* 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).<br>* Other names: No other name;|
| Experimental: Arm Soy Supplement<br>Soy Supplement | Drug: Soy Supplement<br>* 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).<br>* Other names: Fla-vien;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Two weeks | 
| 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. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Estrogen Receptor, Isoflavones, Prostate Neoplasm, Soy Supplementation