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


Phase 2
50 Years
N/A
Not Enrolling
Male
Prostate Cancer

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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 CenterWashington, District of Columbia  20307-5000
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Community General Hospital of Greater SyracuseSyracuse, New York  13215