Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00031746|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 19, 2016
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 or disease||Intervention/treatment||Phase|
|Prostate Cancer||Dietary Supplement: soy protein isolate Dietary Supplement: casein proteins||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Effects of Dietary Soy on Biomarkers of Prostate Cancer: A Prospective Phase II Study|
|Study Start Date :||February 2000|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||June 2006|
|Active Comparator: soy protein + isoflavones||
Dietary Supplement: soy protein isolate
25 mg daily
|Active Comparator: casein proteins||
Dietary Supplement: casein proteins
25 mg daily
- Reduction of prostatic cellular proliferation rates by 50% as measured by Ki-67 [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031746
|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|
|Study Chair:||James L. Mohler, MD||Roswell Park Cancer Institute|