Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Radiation: 3D-CRT
- Registration Number
- NCT00002602
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients who have previously untreated stage II or stage III prostate cancer.
- Detailed Description
OBJECTIVES: I. Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy to the prostate gland and immediately surrounding tissues in patients with stage II or III adenocarcinoma of the prostate. II. Determine the normal tissue toxicity rate of this regimen in the rectums and bladders of these patients. III. Determine local control by clinical and pathologic examination and by PSA determinations in patients treated with this regimen. IV. Determine the distant failure and overall survival of patients treated with this regimen.
OUTLINE: This is a dose escalation study. Patients are stratified according to 1 of the following 3 prognostic groups: Group 1: T1b-c or T2a-b with combined PSA/Gleason (CPG) score 15 and under Group 2: T1b-c or T2a-b with CPG score more than 15, or any T2c with PSA less than 70 ng/mL Group 3: T3 with prostate specific antigen (PSA) less than 70 ng/mL Patients receive 3-dimensional (3-D) conformal radiotherapy 5 days a week for 7.6, 8.2, or 8.8 weeks. Cohorts of 120-270 patients receive escalating doses of 3-D conformal radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 20% of patients experience dose-limiting toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 549-801 patients (120-204 patients for the first dose level, 237-321 patients for the second dose level, and 192-276 patients for the third dose level) will be accrued for this study within 4.75 to 5.25 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1084
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 3D-CRT Clinical stages T1b-c or T2a-b with PSA + (\[Gleason -6\]x10)\>15. Any clinical T2c with PSA \< 70. Must be lymph node negative. Escalating doses of three dimensional conformal radiation therapy (3D-CRT) until the maximum tolerated dose (MTD) is established. Group 1 3D-CRT Clinical stages T1b-c or T2a-b with PSA + (\[Gleason -6\] x 10) is ≤ 15. Escalating doses of three dimensional conformal radiation therapy (3D-CRT) until the maximum tolerated dose (MTD) is established. Group 3 3D-CRT Clinical stage T3 with PSA \< 70. Must be lymph node negative. Escalating doses of three dimensional conformal radiation therapy (3D-CRT) until the maximum tolerated dose (MTD) is established.
- Primary Outcome Measures
Name Time Method To establish the maximum tolerated dose (MTD) of radiation that can be delivered to the prostate gland and immediate surrounding tissues in patients with carcinoma of the prostate using three dimensional conformal radiation therapy (3D-CRT). From registration to approximately 18 months from the start of treatment
- Secondary Outcome Measures
Name Time Method To evaluate local control by clinical, pathologic, and PSA (stable in normal range) determinations From registration to the date of progression or last follow-up. Analysis will occur after the primary endpoint analysis. To quantify the normal tissue toxicity rate (normal tissue complication probability (NTCP)) for rectum and bladder using 3D-CRT From registration to approximately 18 months from the start of treatment Distant metastasis and survival From registration to the date of death or last follow-up. Analysis will occur after the primary endpoint analysis.
Trial Locations
- Locations (228)
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Comprehensive Cancer Institute of Huntsville
🇺🇸Huntsville, Alabama, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
MBCCOP - University of South Alabama
🇺🇸Mobile, Alabama, United States
Alabama Oncology, LLC
🇺🇸Montgomery, Alabama, United States
Radiation Oncology Associates of West Alabama
🇺🇸Tuscaloosa, Alabama, United States
Providence Cancer Therapy Center
🇺🇸Anchorage, Alaska, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Mount Diablo Medical Center
🇺🇸Concord, California, United States
California Cancer Center
🇺🇸Fresno, California, United States
Glendale Memorial Hospital and Health Center
🇺🇸Glendale, California, United States
Saint Agnes Cancer Center
🇺🇸Fresno, California, United States
Sutter Health Western Division Cancer Research Group
🇺🇸Greenbrae, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Veterans Affairs Medical Center - Long Beach
🇺🇸Long Beach, California, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Cancer Care Center
🇺🇸Pomona, California, United States
O'Connor Hospital
🇺🇸San Jose, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
Memorial Hospital Cancer Center
🇺🇸Colorado Springs, Colorado, United States
Whittingham Cancer Center
🇺🇸Norwalk, Connecticut, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
Halifax Medical Center
🇺🇸Daytona Beach, Florida, United States
University of Florida Health Science Center
🇺🇸Gainesville, Florida, United States
Health First Holmes Regional Medical Center
🇺🇸Melbourne, Florida, United States
Radiation Therapy Associates - Fort Myers
🇺🇸Fort Myers, Florida, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Florida Radiation Oncology Group
🇺🇸Orange Park, Florida, United States
Bayfront Medical Center
🇺🇸Saint Petersburg, Florida, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Medical Center/John B. Amos Community Cancer Center
🇺🇸Columbus, Georgia, United States
InterCommunity Cancer Center at Rome
🇺🇸Rome, Georgia, United States
Northwest Community Hospital
🇺🇸Arlington Heights, Illinois, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Lutheran General Cancer Care Center
🇺🇸Park Ridge, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
St. John's Medical Center
🇺🇸Anderson, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Wendt Regional Cancer Center of Finley Hospital
🇺🇸Dubuque, Iowa, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Merle M. Mahr Cancer Center
🇺🇸Madisonville, Kentucky, United States
Western Baptist Hospital
🇺🇸Paducah, Kentucky, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Romagosa Radiation Oncology Center
🇺🇸Lafayette, Louisiana, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Harbor Hospital Center
🇺🇸Baltimore, Maryland, United States
Radiation Oncology Affiliates of Maryland, P.A.
🇺🇸Baltimore, Maryland, United States
Cape Cod Hospital
🇺🇸Hyannis, Massachusetts, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
🇺🇸Jamaica Plain, Massachusetts, United States
McLaren Regional Cancer Center
🇺🇸Flint, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Marquette General Hospital
🇺🇸Marquette, Michigan, United States
MidMichigan Regional Medical Center
🇺🇸Midland, Michigan, United States
St. Mary's Medical Center
🇺🇸Saginaw, Michigan, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Mallinckrodt Institute of Radiology
🇺🇸Saint Louis, Missouri, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States
Elliot Regional Cancer Center
🇺🇸Manchester, New Hampshire, United States
South Jersey Hospital - Millville
🇺🇸Millville, New Jersey, United States
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
🇺🇸Mount Holly, New Jersey, United States
John F. Kennedy Medical Center
🇺🇸Edison, New Jersey, United States
Community Medical Center
🇺🇸Toms River, New Jersey, United States
Trinitas Hospital - Jersey Street Campus
🇺🇸Elizabeth, New Jersey, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
St. Francis Medical Center
🇺🇸Trenton, New Jersey, United States
Saint Joseph Medical Center
🇺🇸Albuquerque, New Mexico, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
Albert Einstein Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
State University of New York Health Science Center at Brooklyn
🇺🇸Brooklyn, New York, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
Finger Lakes Radiation Oncology, P.C.
🇺🇸Clifton Springs, New York, United States
Kaplan Cancer Center
🇺🇸New York, New York, United States
Champlain Valley Physicians Hospital Medical Center
🇺🇸Plattsburgh, New York, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Northeast Medical Center
🇺🇸Concord, North Carolina, United States
Meritcare Roger Maris Cancer Center
🇺🇸Fargo, North Dakota, United States
East Carolina University School of Medicine
🇺🇸Greenville, North Carolina, United States
Catawba Memorial Hospital
🇺🇸Hickory, North Carolina, United States
UNIMED Medical Center
🇺🇸Minot, North Dakota, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Akron City Hospital
🇺🇸Akron, Ohio, United States
St. John Medical Center
🇺🇸Tulsa, Oklahoma, United States
CCOP - Dayton
🇺🇸Kettering, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
Hahnemann University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Penn State Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Mercy Catholic Medical Center, Mercy Fitzgerald Divison
🇺🇸Darby, Pennsylvania, United States
Delaware County Memorial Hospital
🇺🇸Drexel Hill, Pennsylvania, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Penn State Geisinger Cancer Center
🇺🇸Hershey, Pennsylvania, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Veterans Affairs Medical Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
Wilkes Barre General Hospital
🇺🇸Wilkes-Barre, Pennsylvania, United States
Mercy Hospital Cancer Center - Scranton
🇺🇸Scranton, Pennsylvania, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
Roger Williams Medical Center/BUSM
🇺🇸Providence, Rhode Island, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Baptist Regional Cancer Center - Knoxville
🇺🇸Knoxville, Tennessee, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Jackson-Madison County General Hospital
🇺🇸Jackson, Tennessee, United States
CCOP - Baptist Cancer Institute
🇺🇸Memphis, Tennessee, United States
University of Tennessee, Memphis Cancer Center
🇺🇸Memphis, Tennessee, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Julie and Ben Rogers Cancer Institute
🇺🇸Beaumont, Texas, United States
Wilford Hall - 59th Medical Wing
🇺🇸Lackland Air Force Base, Texas, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
Bayshore Medical Center
🇺🇸Pasadena, Texas, United States
East Texas Medical Center - Cancer Institute
🇺🇸Tyler, Texas, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Dixie Regional Medical Center
🇺🇸Saint George, Utah, United States
Naval Medical Center, Portsmouth
🇺🇸Portsmouth, Virginia, United States
CCOP - Southwestern Vermont Regional Cancer Center
🇺🇸Bennington, Vermont, United States
Cancer Center, University of Virginia HSC
🇺🇸Charlottesville, Virginia, United States
Martha Jefferson Hospital
🇺🇸Charlottesville, Virginia, United States
Virginia Baptist Hospital
🇺🇸Lynchburg, Virginia, United States
Deaconess Medical Center
🇺🇸Spokane, Washington, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Schiffler Cancer Center
🇺🇸Wheeling, West Virginia, United States
Yakima Valley Memorial Hospital
🇺🇸Yakima, Washington, United States
Gundersen Lutheran Medical Foundation
🇺🇸La Crosse, Wisconsin, United States
Southern Wisconsin Radiotherapy Center
🇺🇸Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Community Memorial Hospital
🇺🇸Menomonee Falls, Wisconsin, United States
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Southeastern Wisconsin Regional Cancer Center
🇺🇸Racine, Wisconsin, United States
Waukesha Memorial Hospital
🇺🇸Waukesha, Wisconsin, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Doctor Leon Richard Oncology Centre
🇨🇦Moncton, New Brunswick, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Kingston Regional Cancer Centre
🇨🇦Kingston, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
🇨🇦Sudbury, Ontario, Canada
Ottawa Regional Cancer Centre - Civic Campus
🇨🇦Ottawa, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
🇨🇦Thunder Bay, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
McGill University Department of Oncology
🇨🇦Montreal, Quebec, Canada
Kaiser Permanente Medical Center - Los Angeles
🇺🇸Los Angeles, California, United States
Beckman Research Institute, City of Hope
🇺🇸Los Angeles, California, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Mercy Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Cancer Center
🇺🇸Cleveland, Ohio, United States
Community Hospitals of Indianapolis - Regional Cancer Center
🇺🇸Indianapolis, Indiana, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
New York Medical College
🇺🇸Valhalla, New York, United States
York Hospital
🇺🇸York, Pennsylvania, United States
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Stanford University
🇺🇸Stanford, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
West Florida Cancer Institute - Pensacola
🇺🇸Pensacola, Florida, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Sarasota Radiation and Medical Oncology Center
🇺🇸Sarasota, Florida, United States
Veterans Affairs Medical Center - Lexington
🇺🇸Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
MBCCOP - LSU Medical Center
🇺🇸New Orleans, Louisiana, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
Greater Baltimore Medical Center and Cancer Center
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
Clarion Health Partners Inc.
🇺🇸Indianapolis, Indiana, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Anne Arundel Oncology Center
🇺🇸Annapolis, Maryland, United States
St. Joseph's Radiation Oncology Center
🇺🇸South Bend, Indiana, United States
Ball Memorial Hospital
🇺🇸Muncie, Indiana, United States
Christ Hospital
🇺🇸Cincinnati, Ohio, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Vanderbilt Cancer Center
🇺🇸Nashville, Tennessee, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
Green Mountain Oncology Group
🇺🇸Rutland, Vermont, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
St. Joseph's Hospital
🇺🇸Milwaukee, Wisconsin, United States
Columbia Hospital
🇺🇸Milwaukee, Wisconsin, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
🇺🇸Milwaukee, Wisconsin, United States
Radiation Oncology Center - Sacramento
🇺🇸Sacramento, California, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Methodist Cancer Center - Omaha
🇺🇸Omaha, Nebraska, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
MD Anderson Cancer Center Orlando
🇺🇸Orlando, Florida, United States
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Louisville Radiation Oncology
🇺🇸Louisville, Kentucky, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Vassar Brothers Hospital
🇺🇸Poughkeepsie, New York, United States
Gulf Coast Cancer Treatment Center
🇺🇸Panama City, Florida, United States