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

Prostate Cancer Clinical Trial

Official title:

Effects of Dietary Soy on Biomarkers of Prostate Cancer: A Prospective Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00031746
• Other study ID #: CALGB-79806
• Secondary ID: U10CA076001CALGB
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2002
• Last updated: July 15, 2016
• Start date: February 2000
• Est. completion date: June 2006

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed absence of prostate cancer

• Atypical adenomatous hyperplasia or prostatic intraepithelial neoplasia (high-grade or low-grade) allowed

• Abnormal baseline transrectal ultrasound and digital rectal exam allowed

• Biopsy may be before or after study entry, but must be within the past 90 days

• PSA 5-10 ng/mL

PATIENT CHARACTERISTICS:

Age:

• 50 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No known allergy to soy protein or milk protein

• No invasive cancer within the past 5 years except non-melanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• No prior hormonal therapy

• No prior finasteride

• No concurrent hormonal therapy

• No concurrent finasteride

Radiotherapy:

• Not specified

Surgery:

• At least 6 months since prior transurethral resection of the prostate

• No prior orchiectomy

• No concurrent orchiectomy

Other:

• No other concurrent soy products

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• soy protein isolate
25 mg daily
• casein proteins
25 mg daily

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University	Columbus	Ohio
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	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of prostatic cellular proliferation rates by 50% as measured by Ki-67		12 months	No