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



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

For Condition: Prostate Cancer
Status: Recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Soy protein supplement may prevent or delay the development of prostate cancer in patients who have elevated prostate-specific antigen (PSA) levels. PURPOSE: Randomizedphase II trial to determine the effectiveness of soy protein supplement in preventing prostate cancer in patients who have elevated PSA levels.
Details: 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:
Study Type:
  Interventional, Prevention
Minimum Age/Maximum Age: 50 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
WilliamLee,  Study Chair,  Comprehensive Cancer Center of Wake Forest University

West Suburban Center for Cancer Care *Recruiting*
River Forest,  Illinois,  60305
United States
Recruiting John  Showel 708-763-2700

Broward General Medical Center *Recruiting*
Ft. Lauderdale,  Florida,  33316
United States
Recruiting Luis  Barreras 954-771-0692

Cooper University Hospital *Recruiting*
Camden,  New Jersey,  08103
United States
Recruiting Edison  Catalano 856-342-2506

Saint Anthony Medical Center *Recruiting*
Rockford,  Illinois,  61108
United States
Recruiting Richard  Nora 815-227-2273

Palm Beach Cancer Institute *Recruiting*
West Palm Beach,  Florida,  33401
United States
Recruiting Robert  Jacobson 561-366-4150

Veterans Affairs Medical Center - Dallas *Recruiting*
Dallas,  Texas,  75216
United States
Recruiting Barry  Levinson 214-648-4193

FirstHealth Moore Regional Hospital *Recruiting*
Pinehurst,  North Carolina,  28374
United States
Recruiting Ellen  Willard 910-295-9205

New Hampshire Oncology-Hematology, PA - Hooksett *Recruiting*
Hooksett,  New Hampshire,  03106
United States
Recruiting Douglas  Weckstein 603-622-6484

University of Puerto Rico School of Medicine Medical Sciences Campus *Recruiting*
San Juan,  ,  00936-5067
Puerto Rico
Recruiting Enrique  Velez-Garcia 787-754-0101 Ext.2020

Veterans Affairs Medical Center - Las Vegas *Recruiting*
Las Vegas,  Nevada,  89106
United States
Recruiting Chitha  Hulugalle 702-696-3000

Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem,  North Carolina,  27157-1082
United States
Recruiting David  Hurd 336-716-2088

Oncology Care Center - Belleville *Recruiting*
Belleville,  Illinois,  62226
United States
Recruiting Gabriel  Carabulea 618-236-1000

Veterans Affairs Medical Center - San Diego *Recruiting*
San Diego,  California,  92161
United States
Recruiting Saeeda  Kirmani 619-552-8585 ext. 3356

Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne,  Indiana,  46885-5099
United States
Recruiting Sreenivasa  Nattam 219-484-8830

Cape Fear Valley Health System *Recruiting*
Fayetteville,  North Carolina,  28302-2000
United States
Recruiting Kamal  Bakri 910-609-6910

CCOP - Christiana Care Health Services *Recruiting*
Newark,  Delaware,  19713
United States
Recruiting Stephen  Grubbs 302-623-4100

Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph *Recruiting*
Saint Joseph,  Michigan,  49085
United States
Recruiting Eric  Lester 269-982-4963

University of Iowa Hospitals and Clinics *Recruiting*
Iowa City,  Iowa,  52242-1083
United States
Recruiting Gerald  Clamon 319-356-7360

Lenoir Memorial Hospital Cancer Center *Recruiting*
Kinston,  North Carolina,  28503-1678
United States
Recruiting Peter  Watson 919-559-2200 Ext. 201

Oncology and Hematology Associates of Southwest Virginia, Inc. *Recruiting*
Roanoke,  Virginia,  24014
United States
Recruiting Paul  Richards 540-982-0237

New Hanover Regional Medical Center *Recruiting*
Wilmington,  North Carolina,  28402-9025
United States
Recruiting Cyrus  Kotwall 910-763-4630

Virginia Oncology Associates - Norfolk *Recruiting*
Norfolk,  Virginia,  23502
United States
Recruiting Paul  Conkling 757-466-8683

Veterans Affairs Medical Center - Washington, DC *Recruiting*
Washington D.C.,  District of Columbia,  20422
United States
Recruiting Steven  Krasnow 202-745-8178

NorthEast Oncology Associates *Recruiting*
Concord,  North Carolina,  28025
United States
Recruiting James  Wall 704-783-1370

St. Mary's Medical Center *Recruiting*
Huntington,  West Virginia,  25701
United States
Recruiting Gerrit  Kimmey 304-528-4645

Florida Hospital Cancer Institute *Recruiting*
Orlando,  Florida,  32804
United States
Recruiting Jane  Crofton 407-303-2090

CCOP - Kansas City *Recruiting*
Kansas City,  Missouri,  64131
United States
Recruiting Jorge  Paradelo 816-823-0555

CCOP - Illinois Oncology Research Association *Recruiting*
Peoria,  Illinois,  61602
United States
Recruiting John  Kugler 309-636-3605

Baptist Hospital East - Louisville *Recruiting*
Louisville,  Kentucky,  40207
United States
Recruiting Daniel  Scullin 502-897-1166

Walter Reed Army Medical Center *Recruiting*
Washington D.C.,  District of Columbia,  20307-5001
United States
Recruiting David  McLeod 202-782-6408

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha *Recruiting*
Omaha,  Nebraska,  68114
United States
Recruiting Stephen  Lemon 402-354-5860

Queens Cancer Center of Queens Hospital *Recruiting*
Jamaica,  New York,  11432
United States
Recruiting Hans  Grunwald 718-883-4118

University of Chicago Cancer Research Center *Recruiting*
Chicago,  Illinois,  60637-1470
United States
Recruiting Karen  Wendling 773-834-7424

CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem,  North Carolina,  27104-4241
United States
Recruiting James  Atkins 336-777-3036

Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Recruiting Howard  Ozer 405-271-4022

Elmhurst Hospital Center *Recruiting*
Elmhurst,  New York,  11373
United States
Recruiting Vladimir  Benisovich 718-334-3723

Veterans Affairs Medical Center - Asheville *Recruiting*
Asheville,  North Carolina,  28805
United States
Recruiting John  Lucke 828-299-2540

Northeast Alabama Regional Medical Center *Recruiting*
Anniston,  Alabama,  36207
United States
Recruiting Thomas  Twele 256-236-2549

Louis A. Weiss Memorial Hospital *Recruiting*
Chicago,  Illinois,  60640
United States
Recruiting Keith  Shulman 773-564-5022

Martha Jefferson Hospital *Recruiting*
Charlottesville,  Virginia,  22902
United States
Recruiting Stefan  Gorsch 434-982-8410

Ohio State University *Recruiting*
Columbus,  Ohio,  43210
United States
Recruiting Steven  Clinton 614-293-7560

Memorial Regional Hospital Comprehensive Cancer Center *Recruiting*
Hollywood,  Florida,  33021
United States
Recruiting Atif  Hussein 954-986-6363


Additional Information:
Study ID Numbers:
  CDR0000069221;  CALGB-79806,NCI-P02-0207
Study Start Date: 
Record last reviewed: March 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031746

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