|
Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels Clinical research trials and Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as 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 Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels clinical trial. Participants frequently get the best healthcare available for their Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > 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
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
Other Prostate Cancer Studies:
1. ET-743 in Men with Advanced Prostate Cancer
2. Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer
3. Lycopene In Preventing of Prostate Cancer
4. Study of Prostate Cancer in Black and White U.S. Veterans
5. GTI-2040 and Docetaxel in Treating Patients With Recurrent, Metastatic, or Unresectable Locally Advanced Non-Small Cell Lung Cancer, Prostate Cancer, or Other Solid Tumors
Related Studies:
Other Prostate Cancer Clinical Trials
Other New Hampshire Clinical Trials
Other Hooksett Clinical Trials
Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels
|
|
|
|
|
|
|
|