Effects of Dietary Soy on Biomarkers of Prostate Cancer: A Prospective Phase II Study
50 Years
N/A
Male
Prostate Cancer
Trial Information
Effects of Dietary Soy on Biomarkers of Prostate Cancer: A Prospective Phase II Study
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.
Inclusion 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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Outcome Measure:
Reduction of prostatic cellular proliferation rates by 50% as measured by Ki-67
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
James L. Mohler, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000069221
NCT ID:
NCT00031746
Start Date:
February 2000
Completion Date:
Related Keywords:
- Prostate Cancer
- prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
| Community General Hospital of Greater Syracuse | Syracuse, New York 13215 |
