Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels
NCT ID: NCT00031746
Last Updated: 2016-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
26 participants
INTERVENTIONAL
2000-02-29
2006-06-30
Brief Summary
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PURPOSE: Randomized phase II trial to determine the effectiveness of soy protein supplement in preventing prostate cancer in patients who have elevated PSA levels.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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soy protein + isoflavones
soy protein isolate
25 mg daily
casein proteins
casein proteins
25 mg daily
Interventions
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soy protein isolate
25 mg daily
casein proteins
25 mg daily
Eligibility Criteria
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Inclusion Criteria
* 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
50 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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James L. Mohler, MD
Role: STUDY_CHAIR
Roswell Park Cancer Institute
Locations
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Walter Reed Army Medical Center
Washington D.C., District of Columbia, 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
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
Countries
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Other Identifiers
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CALGB-79806
Identifier Type: -
Identifier Source: secondary_id
NCI-P02-0207
Identifier Type: -
Identifier Source: secondary_id
CDR0000069221
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-79806
Identifier Type: -
Identifier Source: org_study_id
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