Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
Eligibility Criteria
Inclusion criteria: Histologically confirmed locally confined adenocarcinoma of the prostate with primary tumors confined to the prostate, clinical stage T1b,1c, 2a or 2b. Negative nodes evaluated by imaging methods (classified in the study as NX) or by surgical sampling (classified in the study as N0). Karnofsky performance status ≥ 70. PSA is mandatory, must be ≤ 20) No prior hormonal therapy, radiation or chemotherapy. Prior finasteride for prostate hypertrophy allowed if discontinued at least 60 days prior to randomization. Prior testosterone administration allowed if at least 90 days elapsed since last administration. No evidence of distant metastasis or other synchronous primary. Patients with prior invasive malignancy who were disease free for at least 5 years could be eligible with pre-randomization approval by the study chairman. Treatment begins within 21 days after randomization. Patients signs a study-specific informed consent form. Alanine Aminotransferase (ALT) within 2x upper normal limits. Exclusion criteria: Stage T1a or ≥ T2c disease. Lymph node involvement (N1 - N3). Evidence of distant metastasis. (M1) PSA > 20. Radical surgery or cryosurgery for carcinoma of the prostate, previous irradiation, antiandrogen therapy or chemotherapy. Previous or concurrent cancers other than basal cell or squamous cell skin carcinoma. Patients with squamous cell carcinomas required to be NED (no evidence of disease) for a minimum of two years prior to study entry. Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up. Karnofsky performance status of < 70.
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- Huntsville Hospital System
- Comprehensive Cancer Institute of Huntsville
- MBCCOP - Gulf Coast
- Alabama Oncology, LLC
- Radiation Oncology Associates of West Alabama
- Providence Alaska Medical Center
- Arizona Cancer Center
- Mount Diablo Medical Center
- Cancer Center and Beckman Research Institute, City of Hope
- California Cancer Center
- Saint Agnes Cancer Center
- Glendale Memorial Hospital and Health Center
- Sutter Health Western Division Cancer Research Group
- University of California San Diego Cancer Center
- Loma Linda University Medical Center
- Veterans Affairs Medical Center - Long Beach
- USC/Norris Comprehensive Cancer Center and Hospital
- Jonsson Comprehensive Cancer Center, UCLA
- CCOP - Bay Area Tumor Institute
- Cancer Care Center
- Radiation Oncology Center - Sacramento
- Radiation Medical Group, Inc.
- UCSF Cancer Center and Cancer Research Institute
- O'Connor Hospital
- CCOP - Santa Rosa Memorial Hospital
- Memorial Hospital Cancer Center
- University of Colorado Cancer Center
- CCOP - Christiana Care Health Services
- Walter Reed Army Medical Center
- Lykes Center for Radiation Therapy
- Halifax Medical Center
- Radiation Therapy Associates - Fort Myers
- University of Florida Health Science Center
- Health First Holmes Regional Medical Center
- CCOP - Mount Sinai Medical Center
- dVeterans Affairs Medical Center - Miami
- Sylvester Cancer Center, University of Miami
- Baptist Hospital of Miami
- Florida Radiation Oncology Group
- MD Anderson Cancer Center Orlando
- Bay Medical Center
- Gulf Coast Cancer Treatment Center
- Sarasota Radiation and Medical Oncology Center
- Tallahassee Memorial Healthcare
- H. Lee Moffitt Cancer Center and Research Institute
- Emory University Hospital - Atlanta
- CCOP - Atlanta Regional
- Medical Center/John B. Amos Community Cancer Center
- InterCommunity Cancer Center at Rome
- Northwest Community Hospital
- Northwestern Memorial Hospital
- University of Chicago Cancer Research Center
- CCOP - Central Illinois
- Provena St. Joseph Hospital- Regional Cancer Care Center
- Ingalls Memorial Hospital
- Loyola University Medical Center
- Lutheran General Cancer Care Center
- Methodist Medical Center of Illinois
- St. John's Medical Center
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
- Clarion Health Partners Inc.
- Community Hospitals of Indianapolis - Regional Cancer Center
- Ball Memorial Hospital
- Wendt Regional Cancer Center of Finley Hospital
- Holden Comprehensive Cancer Center at The University of Iowa
- Veterans Affairs Medical Center - Lexington
- Albert B. Chandler Medical Center, University of Kentucky
- James Graham Brown Cancer Center
- Louisville Radiation Oncology
- Merle M. Mahr Cancer Center
- Mary Bird Perkins Cancer Center
- Romagosa Radiation Oncology Center
- MBCCOP - LSU Health Sciences Center
- Tulane University School of Medicine
- CCOP - Ochsner
- Maine Medical Center
- Anne Arundel Oncology Center
- Greater Baltimore Medical Center and Cancer Center
- Harbor Hospital Center
- Sinai Hospital of Baltimore
- Johns Hopkins Oncology Center
- Radiation Oncology Affiliates of Maryland, P.A.
- Peninsula Regional Medical Center
- Cape Cod Hospital
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
- CCOP - Ann Arbor Regional
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Henry Ford Hospital
- McLaren Regional Cancer Center
- Hurley Medical Center
- CCOP - Kalamazoo
- Marquette General Hospital
- MidMichigan Medical Center - Midland
- William Beaumont Hospital
- St. Mary's Medical Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- North Mississippi Medical Center/Cancer Center
- Ellis Fischel Cancer Center - Columbia
- CCOP - Kansas City
- St. Louis University Health Sciences Center
- Mallinckrodt Institute of Radiology
- Cancer Research for the Ozarks
- CCOP - Cancer Research for the Ozarks
- CCOP - Montana Cancer Consortium
- Nebraska Health System
- Methodist Cancer Center - Omaha
- CCOP - Southern Nevada Cancer Research Foundation
- Norris Cotton Cancer Center
- Elliot Regional Cancer Center
- Cooper Cancer Institute
- Veterans Affairs Medical Center - East Orange
- John F. Kennedy Medical Center
- Trinitas Hospital - Jersey Street Campus
- Monmouth Medical Center
- South Jersey Regional Cancer Center
- Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
- Cancer Institute of New Jersey
- Newark Beth Israel Medical Center
- Atlantic City Medical Center
- Community Medical Center
- Capital Health System at Mercer
- St. Francis Medical Center
- Associated Radiologists, P.A.
- Saint Joseph Medical Center
- Cancer Center of Albany Medical Center
- Albert Einstein Comprehensive Cancer Center
- State University of New York Health Science Center at Brooklyn
- New York Methodist Hospital
- Roswell Park Cancer Institute
- Finger Lakes Radiation Oncology, P.C.
- CCOP - North Shore University Hospital
- Beth Israel Medical Center
- Memorial Sloan-Kettering Cancer Center
- Herbert Irving Comprehensive Cancer Center
- Champlain Valley Physicians Hospital Medical Center
- Vassar Brothers Hospital
- University of Rochester Cancer Center
- New York Medical College
- Lineberger Comprehensive Cancer Center, UNC
- Northeast Medical Center
- East Carolina University School of Medicine
- Catawba Memorial Hospital
- CCOP - Southeast Cancer Control Consortium
- Comprehensive Cancer Center at Wake Forest University
- Meritcare Roger Maris Cancer Center
- Akron General Medical Center
- Akron City Hospital
- Christ Hospital
- Ireland Cancer Center
- University Hospitals of Cleveland
- CCOP - Columbus
- Arthur G. James Cancer Hospital - Ohio State University
- CCOP - Dayton
- CCOP - Toledo Community Hospital Oncology Program
- St. Anthony Hospital
- St. John Health System
- CCOP - Columbia River Program
- Lehigh Valley Hospital
- St. Luke's Hospital Regional Cancer Center
- Geisinger Medical Center
- Mercy Catholic Medical Center, Mercy Fitzgerald Divison
- Delaware County Memorial Hospital
- Penn State Geisinger Cancer Center
- Hahnemann University Hospital
- University of Pennsylvania Cancer Center
- Veterans Affairs Medical Center - Philadelphia
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center
- Albert Einstein Cancer Center
- University of Pittsburgh Cancer Institute
- Mercy Hospital of Pittsburgh
- Western Pennsylvania Hospital
- Reading Hospital and Medical Center
- Mercy Hospital Cancer Center - Scranton
- Wilkes Barre General Hospital
- CCOP - MainLine Health
- York Hospital
- Roger Williams Medical Center/BUSM
- Medical University of South Carolina
- CCOP - Greenville
- CCOP - Upstate Carolina
- Rapid City Regional Hospital
- Jackson-Madison County General Hospital
- University of Tennessee, Memphis Cancer Center
- Vanderbilt-Ingram Cancer Center
- Harrington Cancer Center
- Julie and Ben Rogers Cancer Institute
- University of Texas Medical Branch
- University of Texas - MD Anderson Cancer Center
- Wilford Hall - 59th Medical Wing
- Joe Arrington Cancer Research and Treatment Center
- Bayshore Medical Center
- East Texas Medical Center - Cancer Institute
- Dixie Regional Medical Center
- University of Utah Health Sciences Center
- LDS Hospital
- CCOP - Southwestern Vermont Regional Cancer Center
- Vermont Cancer Center
- Green Mountain Oncology Group
- Martha Jefferson Hospital
- Cancer Center at the University of Virginia
- RMH Regional Canter Center
- Virginia Mason Medical Center
- Deaconess Medical Center
- Yakima Valley Memorial Hospital
- Schiffler Cancer Center
- St. Vincent Hospital
- Gundersen Lutheran Medical Foundation
- Southern Wisconsin Radiotherapy Center
- University of Wisconsin Comprehensive Cancer Center
- Marshfield Clinic
- Community Memorial Hospital
- St. Joseph's Hospital
- Columbia Hospital
- St. Luke's Medical Center
- Medical College of Wisconsin
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
- Southeastern Wisconsin Regional Cancer Center
- Waukesha Memorial Hospital
- Tom Baker Cancer Center - Calgary
- Cross Cancer Institute
- British Columbia Cancer Agency
- Saint John Regional Hospital
- Newfoundland Cancer Treatment and Research Foundation
- Nova Scotia Cancer Centre
- Cancer Care Ontario-Hamilton Regional Cancer Centre
- Kingston Regional Cancer Centre
- Cancer Care Ontario-London Regional Cancer Centre
- Ottawa Regional Cancer Centre - General Campus
- Northeastern Ontario Regional Cancer Centre, Sudbury
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
- Toronto Sunnybrook Regional Cancer Centre
- Princess Margaret Hospital
- CHUS-Hopital Fleurimont
- McGill University
- Saskatoon Cancer Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Neoadjuvant TAS + RT
Radiation therapy alone
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
Radiation therapy alone