Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Dietary supplementation with soy may keep prostate cancer from growing in patients planning to undergo surgery. PURPOSE: This randomized phase II trial is studying a soy supplement to see how well it works compared to a placebo in treating patients undergoing surgery for localized prostate cancer.

Detailed Description
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OBJECTIVES: Primary Compare the effect of dietary supplementation with soy vs placebo on biomarkers of cell cycle regulation, proliferation, differentiation, apoptosis, and signaling pathways in patients with localized prostate cancer scheduled to undergo radical prostatectomy. Secondary Compare the toxicity and side effects of these regimens in these patients. Compare the dietary patterns of these patients. OUTLINE: This is a prospective, randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral soy supplementation daily for 4 weeks. Arm II: Patients receive oral placebo supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy or placebo supplementation. Blood and tissue samples are collected for biomarker analysis using immunohistochemistry.

Official Title
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Randomized Phase IIb Preprostatectomy Study of Dietary Supplementation With Soy and Biomarkers of Prostate Cancer Risk and Progression

Conditions
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Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: soy isoflavones
* Dietary Supplement: soy protein isolate
* Other: placebo


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Clinically localized disease Scheduled for radical prostatectomy No evidence of metastatic disease by bone scan or CT scan of the abdomen or pelvis PATIENT CHARACTERISTICS: ECOG performance status 0-2 No evidence of active nephrolithiasis No history of hypercalcemic syndrome PRIOR CONCURRENT THERAPY: No prior treatment for prostate cancer, including radiotherapy, systemic chemotherapy, surgery, or investigational drugs No other concurrent dietary supplementation with soy, cholecalciferol (vitamin D), or fish oil

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive oral soy supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy supplementation. | Dietary Supplement: soy isoflavones<br>* Given orally<br>Dietary Supplement: soy protein isolate<br>* Given orally<br>|
| Placebo Comparator: Arm II<br>Patients receive oral placebo supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of placebo supplementation. | Other: placebo<br>* Given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of pretreatment ER-β expression with response to soy supplementation | after a 4 week therapy, within 21 days, a Radical Prostatectomy will be performed, and after that ER-β expression will be measured. | within 21 days after completetion of supplement regimen | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer