Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Dietary Supplement: casein proteins; Dietary Supplement: soy protein isolate

• Registration Number: NCT00031746
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

RATIONALE: Soy protein supplement may prevent or delay the development of prostate cancer in patients who have elevated prostate-specific antigen (PSA) levels.

PURPOSE: Randomized phase II trial to determine the effectiveness of soy protein supplement in preventing prostate cancer in patients who have elevated PSA levels.

Detailed Description

OBJECTIVES:

* Compare the reduction in the rate of prostatic cellular proliferation in patients with an elevated PSA (5 to 10 ng/mL) and a negative biopsy for prostate cancer when treated with daily soy protein supplements vs placebo.

* Compare the effect of these regimens on additional biomarkers of prostate cancer (PSA, high-grade prostate intraepithelial neoplasia, induction of apoptosis, sex steroid receptor expression, and loss of glutathione S-transferase-pi) in these patients.

* Compare the effect of these regimens on quality of life, including urinary and sexual function, in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to race (Caucasian vs African American). After 2 weeks of daily oral placebo, patients are randomized to 1 of 2 arms.

* Arm I: Patients receive oral soy protein supplement daily for 12 months.

* Arm II: Patients receive oral placebo daily for 12 months. Quality of life is assessed at baseline and at 6 and 12 months.

PROJECTED ACCRUAL: A total of 160 patients (80 per arm) will be accrued for this study within 12 months.

Study Timeline

• Study Start: 2000-02
• Study First Submitted: 2002-03-08
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-15
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
casein proteins	casein proteins	-
soy protein + isoflavones	soy protein isolate	-

Primary Outcome Measures

Name	Time	Method
Reduction of prostatic cellular proliferation rates by 50% as measured by Ki-67	12 months

Trial Locations

Locations (5)

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

Wake Forest University Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States

CCOP - Hematology-Oncology Associates of Central New York; 🇺🇸 Syracuse, New York, United States

Community General Hospital of Greater Syracuse; 🇺🇸 Syracuse, New York, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University; 🇺🇸 Columbus, Ohio, United States