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

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00031746

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Dietary Supplement: soy protein isolate Dietary Supplement: casein proteins	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention
Official Title:	Effects of Dietary Soy on Biomarkers of Prostate Cancer: A Prospective Phase II Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Prostate Cancer

Drug Information available for: Casein Proteins, soy

U.S. FDA Resources

Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:

Reduction of prostatic cellular proliferation rates by 50% as measured by Ki-67 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	26
Study Start Date:	February 2000
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: soy protein + isoflavones	Dietary Supplement: soy protein isolate 25 mg daily
Active Comparator: casein proteins	Dietary Supplement: casein proteins 25 mg daily

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00031746

Locations

United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, New York
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, United States, 13057
Community General Hospital of Greater Syracuse
Syracuse, New York, United States, 13215
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

James L. Mohler, MD

Roswell Park Cancer Institute

More Information

No publications provided

Responsible Party:	Monica M Bertagnolli, MD, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00031746 History of Changes
Other Study ID Numbers:	CDR0000069221, U10CA076001, CALGB-79806, NCI-P02-0207
Study First Received:	March 8, 2002
Last Updated:	August 1, 2011
Health Authority:	United States: Federal Government

Keywords provided by Cancer and Leukemia Group B:

prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male

Prostatic Diseases
Caseins
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012