Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Prevention	Completed	50 and over	NCI	CALGB-79806 NCI-P02-0207, NCT00031746

Objectives

1. 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.
2. 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.
3. Compare the effect of these regimens on quality of life, including urinary and sexual function, in these patients.

Entry Criteria

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

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

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

Expected Enrollment

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

Outcomes

Reduction of prostatic cellular proliferation rates by 50% as measured by Ki-67
Effects of soy supplementation on additional biomarkers of prostate cancer (serum PSA, high-grade prostate intraepithelial neoplasia)
Effects of soy supplementation on health-related quality of life (including urinary and sexual function)

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.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

James Mohler, MD, Protocol chair		Ph: 716-845-3389; 800-685-6825

Registry Information
Official Title		Effects of Dietary Soy on Biomarkers of Prostate Cancer: A Prospective Phase II Study
Trial Start Date		2000-02-15
Trial Completion Date		2008-02-19
Registered in ClinicalTrials.gov		NCT00031746
Date Submitted to PDQ		2002-01-03
Information Last Verified		2006-07-31
NCI Grant/Contract Number		CA76001

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