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 stage I, stage II, or stage III prostate cancer.

Condition	Treatment or Intervention	Phase
stage II prostate cancer stage III prostate cancer stage I prostate cancer adenocarcinoma of the prostate	Procedure: Radiotherapy of the prostate gland and surrounding tissues	Phase I Phase II

Further Study Details: 

OBJECTIVES: I. Estimate the maximum tolerated dose of radiation to the prostate gland and immediately surrounding tissues in patients with carcinoma of the prostate treated with 3-dimensional conformal techniques. II. Quantify the normal tissue toxicity rate for rectum and bladder. III. Evaluate local control by clinical and pathologic examination and by prostate-specific antigen determinations. IV. Assess distant failure and overall survival in these patients.

PROTOCOL OUTLINE: Radiotherapy. Involved-field irradiation using photon energies of at least 10 MV delivered by 3-dimensional conformal techniques, 3D-CRT.

PROJECTED ACCRUAL: 120 patients are required for the first dosage level, 237 for the second level, and 192 for the third level for a total of 549 patients. Because of additional patients being entered at the first level while safety is assessed at the second level, the total number of patients may be as high as 801. Accrual is estimated to be completed in 57-63 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Previously untreated, nonmetastatic adenocarcinoma of the prostate of the following clinical T stages: T1b-c and T2a-b with a Gleason score greater than 5 or a PSA greater than 4; Any T3
• The following exclude: T1a; T1b-c and T2a-b with: Gleason score no greater than 5 AND PSA no greater than 4 T4
• PSA under 70 within 3 weeks prior to entry and at least 10 days after prostate biopsy
• No biopsy-proven regional nodal involvement

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior or concurrent cytotoxic chemotherapy
• Endocrine therapy: Prior hormonal therapy allowed
• Radiotherapy: No prior pelvic irradiation
• Surgery: No prior prostatectomy or cryosurgery for prostate cancer

--Patient Characteristics--

• Age: 18 and over
• Performance status: Karnofsky 80%-100%
• Hematopoietic: WBC at least 4,000 Platelets at least 100,000; Hemoglobin at least 11 g/dL
• Hepatic: Not specified
• Renal: Not specified
• Other: No major medical or psychiatric illness that would prevent completion of treatment or interfere with follow-up; No second malignancy within 5 years

Alabama
      Alabama Oncology, LLC, Montgomery,  Alabama,  36106-2801,  United States
      Comprehensive Cancer Institute of Huntsville, Huntsville,  Alabama,  35801,  United States
      MBCCOP - University of South Alabama, Mobile,  Alabama,  36688,  United States
      Mobile Infirmary Medical Center, Mobile,  Alabama,  36640-0460,  United States
      Radiation Oncology Associates of West Alabama, Tuscaloosa,  Alabama,  35401,  United States
      University of Alabama Comprehensive Cancer Center, Birmingham,  Alabama,  35294,  United States
Alaska
      Providence Cancer Therapy Center, Anchorage,  Alaska,  99508,  United States
Arizona
      Arizona Cancer Center, Tucson,  Arizona,  85724,  United States
California
      Beckman Research Institute, City of Hope, Los Angeles,  California,  91010,  United States
      California Cancer Center, Fresno,  California,  93720,  United States
      Cancer Care Center, Pomona,  California,  91767,  United States
      CCOP - Bay Area Tumor Institute, Oakland,  California,  94609-3305,  United States
      CCOP - Santa Rosa Memorial Hospital, Santa Rosa,  California,  95403,  United States
      Glendale Memorial Hospital and Health Center, Glendale,  California,  91204,  United States
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
      Kaiser Permanente Medical Center - Los Angeles, Los Angeles,  California,  90027,  United States
      Loma Linda University Medical Center, Loma Linda,  California,  92354,  United States
      Mount Diablo Medical Center, Concord,  California,  94524-4110,  United States
      O'Connor Hospital, San Jose,  California,  95128,  United States
      Radiation Oncology Center - Sacramento, Sacramento,  California,  95816,  United States
      Saint Agnes Cancer Center, Fresno,  California,  93720,  United States
      Stanford University, Stanford,  California,  94305,  United States
      Sutter Health Western Division Cancer Research Group, Greenbrae,  California,  94904,  United States
      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94115-0128,  United States
      USC/Norris Comprehensive Cancer Center, Los Angeles,  California,  90033-0800,  United States
      Veterans Affairs Medical Center - Long Beach, Long Beach,  California,  90822,  United States
Colorado
      Memorial Hospital Cancer Center, Colorado Springs,  Colorado,  80909,  United States
      University of Colorado Cancer Center, Denver,  Colorado,  80262,  United States
Connecticut
      Bridgeport Hospital, Bridgeport,  Connecticut,  06610,  United States
      Whittingham Cancer Center, Norwalk,  Connecticut,  06856,  United States
Delaware
      CCOP - Christiana Care Health Services, Wilmington,  Delaware,  19899,  United States
District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States
Florida
      Baptist Hospital of Miami, Miami,  Florida,  33176-2197,  United States
      Bayfront Medical Center, Saint Petersburg,  Florida,  33701,  United States
      CCOP - Mount Sinai Medical Center, Miami Beach,  Florida,  33140,  United States
      Florida Radiation Oncology Group, Orange Park,  Florida,  32073,  United States
      Gulf Coast Cancer Treatment Center, Panama City,  Florida,  32405-4587,  United States
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612,  United States
      Halifax Medical Center, Daytona Beach,  Florida,  32114,  United States
      Health First Holmes Regional Medical Center, Melbourne,  Florida,  32901,  United States
      MD Anderson Cancer Center Orlando, Orlando,  Florida,  32806,  United States
      Radiation Therapy Associates - Fort Myers, Fort Myers,  Florida,  33901,  United States
      Sarasota Radiation and Medical Oncology Center, Sarasota,  Florida,  34233,  United States
      Sylvester Cancer Center, University of Miami, Miami,  Florida,  33136,  United States
      University of Florida Health Science Center, Gainesville,  Florida,  32610-0296,  United States
      West Florida Cancer Institute - Pensacola, Pensacola,  Florida,  32514,  United States
Georgia
      CCOP - Atlanta Regional, Atlanta,  Georgia,  30342-1701,  United States
      Emory University Hospital - Atlanta, Atlanta,  Georgia,  30322,  United States
      InterCommunity Cancer Center at Rome, Rome,  Georgia,  30161,  United States
      Medical Center/John B. Amos Community Cancer Center, Columbus,  Georgia,  31902,  United States
Illinois
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States
      Ingalls Memorial Hospital, Harvey,  Illinois,  60426,  United States
      Loyola University Medical Center, Maywood,  Illinois,  60153,  United States
      Lutheran General Cancer Care Center, Park Ridge,  Illinois,  60068,  United States
      Methodist Medical Center of Illinois, Peoria,  Illinois,  61636,  United States
      Northwest Community Hospital, Arlington Heights,  Illinois,  60005,  United States
      Northwestern Memorial Hospital, Chicago,  Illinois,  60611,  United States
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States
Indiana
      Ball Memorial Hospital, Muncie,  Indiana,  47303-3499,  United States
      Clarion Health Partners Inc., Indianapolis,  Indiana,  46206-1367,  United States
      Community Hospitals of Indianapolis - Regional Cancer Center, Indianapolis,  Indiana,  46219,  United States
      Memorial Hospital of South Bend, South Bend,  Indiana,  46601,  United States
      St. John's Medical Center, Anderson,  Indiana,  46016,  United States
      St. Joseph's Radiation Oncology Center, South Bend,  Indiana,  46617,  United States
Iowa
      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242,  United States
      Wendt Regional Cancer Center of Finley Hospital, Dubuque,  Iowa,  52001,  United States
Kentucky
      Albert B. Chandler Medical Center, University of Kentucky, Lexington,  Kentucky,  40536-0084,  United States
      James Graham Brown Cancer Center, Louisville,  Kentucky,  40202,  United States
      Louisville Radiation Oncology, Louisville,  Kentucky,  40215,  United States
      Merle M. Mahr Cancer Center, Madisonville,  Kentucky,  42431,  United States
      Veterans Affairs Medical Center - Lexington, Lexington,  Kentucky,  40511-1093,  United States
      Western Baptist Hospital, Paducah,  Kentucky,  42001,  United States
Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States
      Mary Bird Perkins Cancer Center, Baton Rouge,  Louisiana,  70809,  United States
      MBCCOP - LSU Medical Center, New Orleans,  Louisiana,  70112,  United States
      Romagosa Radiation Oncology Center, Lafayette,  Louisiana,  70501,  United States
      Tulane University School of Medicine, New Orleans,  Louisiana,  70112,  United States
Maine
      Maine Medical Center, Portland,  Maine,  04102,  United States
Maryland
      Anne Arundel Oncology Center, Annapolis,  Maryland,  21401,  United States
      Greater Baltimore Medical Center and Cancer Center, Baltimore,  Maryland,  21204,  United States
      Harbor Hospital Center, Baltimore,  Maryland,  21225,  United States
      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21231,  United States
      Radiation Oncology Affiliates of Maryland, P.A., Baltimore,  Maryland,  21237,  United States
Massachusetts
      Cape Cod Hospital, Hyannis,  Massachusetts,  02601,  United States
      Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain,  Massachusetts,  02130,  United States
Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201,  United States
      CCOP - Ann Arbor Regional, Ann Arbor,  Michigan,  48106,  United States
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States
      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States
      Hurley Medical Center, Flint,  Michigan,  48503,  United States
      Marquette General Hospital, Marquette,  Michigan,  49855,  United States
      McLaren Regional Cancer Center, Flint,  Michigan,  48432,  United States
      MidMichigan Regional Medical Center, Midland,  Michigan,  48670,  United States
      St. Mary's Medical Center, Saginaw,  Michigan,  48601,  United States
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0752,  United States
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Missouri
      Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States
      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States
      Mallinckrodt Institute of Radiology, Saint Louis,  Missouri,  63110,  United States
      St. Louis University Health Sciences Center, Saint Louis,  Missouri,  63110-0250,  United States
Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States
Nebraska
      Methodist Cancer Center - Omaha, Omaha,  Nebraska,  68114,  United States
Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States
New Hampshire
      Elliot Regional Cancer Center, Manchester,  New Hampshire,  03103,  United States
      Norris Cotton Cancer Center, Lebanon,  New Hampshire,  03756,  United States
New Jersey
      Community Medical Center, Toms River,  New Jersey,  08755,  United States
      Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County, Mount Holly,  New Jersey,  08060,  United States
      John F. Kennedy Medical Center, Edison,  New Jersey,  08818,  United States
      Newark Beth Israel Medical Center, Newark,  New Jersey,  07112,  United States
      South Jersey Hospital - Millville, Millville,  New Jersey,  08332,  United States
      St. Francis Medical Center, Trenton,  New Jersey,  08629,  United States
      Trinitas Hospital - Jersey Street Campus, Elizabeth,  New Jersey,  07201,  United States
      Veterans Affairs Medical Center - East Orange, East Orange,  New Jersey,  07018-1095,  United States
New Mexico
      Saint Joseph Medical Center, Albuquerque,  New Mexico,  87102,  United States
New York
      Albert Einstein Comprehensive Cancer Center, Bronx,  New York,  10461,  United States
      Beth Israel Medical Center, New York,  New York,  10003,  United States
      Cancer Center of Albany Medical Center, Albany,  New York,  12208,  United States
      CCOP - North Shore University Hospital, Manhasset,  New York,  11030,  United States
      Champlain Valley Physicians Hospital Medical Center, Plattsburgh,  New York,  12901,  United States
      Finger Lakes Radiation Oncology, P.C., Clifton Springs,  New York,  14432,  United States
      Kaplan Cancer Center, New York,  New York,  10016,  United States
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
      New York Medical College, Valhalla,  New York,  10595,  United States
      New York Methodist Hospital, Brooklyn,  New York,  11215-3609,  United States
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States
      State University of New York Health Science Center at Brooklyn, Brooklyn,  New York,  11203,  United States
      University of Rochester Cancer Center, Rochester,  New York,  14642,  United States
      Vassar Brothers Hospital, Poughkeepsie,  New York,  12601,  United States
North Carolina
      Catawba Memorial Hospital, Hickory,  North Carolina,  28601,  United States
      CCOP - Southeast Cancer Control Consortium, Winston Salem,  North Carolina,  27104-4241,  United States
      Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston Salem,  North Carolina,  27157-1082,  United States
      East Carolina University School of Medicine, Greenville,  North Carolina,  27858-4354,  United States
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
      Northeast Medical Center, Concord,  North Carolina,  28025,  United States
North Dakota
      Meritcare Roger Maris Cancer Center, Fargo,  North Dakota,  58122,  United States
      UNIMED Medical Center, Minot,  North Dakota,  58701,  United States
Ohio
      Akron City Hospital, Akron,  Ohio,  44309,  United States
      Akron General Medical Center, Akron,  Ohio,  44302,  United States
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210,  United States
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States
      CCOP - Dayton, Kettering,  Ohio,  45429,  United States
      CCOP - Toledo Community Hospital Oncology Program, Toledo,  Ohio,  43623-3456,  United States
      Christ Hospital, Cincinnati,  Ohio,  45219,  United States
      Cleveland Clinic Cancer Center, Cleveland,  Ohio,  44195,  United States
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States
      University Hospitals of Cleveland, Cleveland,  Ohio,  44106,  United States
Oklahoma
      St. John Medical Center, Tulsa,  Oklahoma,  74104,  United States
Oregon
      CCOP - Columbia River Program, Portland,  Oregon,  97213,  United States
Pennsylvania
      Albert Einstein Cancer Center, Philadelphia,  Pennsylvania,  19141,  United States
      CCOP - MainLine Health, Wynnewood,  Pennsylvania,  19096,  United States
      Delaware County Memorial Hospital, Drexel Hill,  Pennsylvania,  19026,  United States
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States
      Hahnemann University Hospital, Philadelphia,  Pennsylvania,  19102-1192,  United States
      Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107,  United States
      Lehigh Valley Hospital, Allentown,  Pennsylvania,  18103,  United States
      Mercy Catholic Medical Center, Mercy Fitzgerald Divison, Darby,  Pennsylvania,  19023,  United States
      Mercy Hospital Cancer Center - Scranton, Scranton,  Pennsylvania,  18501,  United States
      Mercy Hospital of Pittsburgh, Pittsburgh,  Pennsylvania,  15219,  United States
      Penn State Geisinger Cancer Center, Hershey,  Pennsylvania,  17033,  United States
      Penn State Geisinger Medical Center, Danville,  Pennsylvania,  17822-2001,  United States
      Reading Hospital and Medical Center, Reading,  Pennsylvania,  19612-6052,  United States
      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104,  United States
      University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15213,  United States
      Veterans Affairs Medical Center - Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States
      Western Pennsylvania Hospital, Pittsburgh,  Pennsylvania,  15224,  United States
      Wilkes Barre General Hospital, Wilkes Barre,  Pennsylvania,  18764,  United States
      York Hospital, York,  Pennsylvania,  17315,  United States
Rhode Island
      Roger Williams Medical Center/BUSM, Providence,  Rhode Island,  02908-4735,  United States
South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States
      Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States
Tennessee
      Baptist Regional Cancer Center - Knoxville, Knoxville,  Tennessee,  37901,  United States
      CCOP - Baptist Cancer Institute, Memphis,  Tennessee,  38117,  United States
      Jackson-Madison County General Hospital, Jackson,  Tennessee,  38301,  United States
      University of Tennessee, Memphis Cancer Center, Memphis,  Tennessee,  38163,  United States
      Vanderbilt Cancer Center, Nashville,  Tennessee,  37232-6838,  United States
Texas
      Bayshore Medical Center, Pasadena,  Texas,  77504,  United States
      East Texas Medical Center - Cancer Institute, Tyler,  Texas,  75701,  United States
      Harrington Cancer Center, Amarillo,  Texas,  79106,  United States
      Joe Arrington Cancer Research and Treatment Center, Lubbock,  Texas,  79410-1894,  United States
      Julie and Ben Rogers Cancer Institute, Beaumont,  Texas,  77701,  United States
      University of Texas Medical Branch, Galveston,  Texas,  77555-1329,  United States
      Wilford Hall - 59th Medical Wing, Lackland Air Force Base,  Texas,  78236-5300,  United States
Utah
      Dixie Regional Medical Center, Saint George,  Utah,  84770,  United States
      LDS Hospital, Salt Lake City,  Utah,  84143,  United States
Vermont
      CCOP - Southwestern Vermont Regional Cancer Center, Bennington,  Vermont,  05201,  United States
      Green Mountain Oncology Group, Rutland,  Vermont,  05701,  United States
      Vermont Cancer Center, Burlington,  Vermont,  05401-3498,  United States
Virginia
      Cancer Center, University of Virginia HSC, Charlottesville,  Virginia,  22908,  United States
      Martha Jefferson Hospital, Charlottesville,  Virginia,  22901,  United States
      Naval Medical Center, Portsmouth, Portsmouth,  Virginia,  23708-2197,  United States
      Virginia Baptist Hospital, Lynchburg,  Virginia,  24503,  United States
Washington
      Deaconess Medical Center, Spokane,  Washington,  99210-0248,  United States
      Swedish Cancer Institute, Seattle,  Washington,  98104,  United States
      Virginia Mason Medical Center, Seattle,  Washington,  98111,  United States
      Yakima Valley Memorial Hospital, Yakima,  Washington,  98902,  United States
West Virginia
      Schiffler Cancer Center, Wheeling,  West Virginia,  26003,  United States
Wisconsin
      Columbia Hospital, Milwaukee,  Wisconsin,  53211,  United States
      Community Memorial Hospital, Menomonee Falls,  Wisconsin,  53051,  United States
      Gundersen Lutheran Medical Foundation, La Crosse,  Wisconsin,  54601,  United States
      Marshfield Clinic, Marshfield,  Wisconsin,  54449,  United States
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States
      Southeastern Wisconsin Regional Cancer Center, Racine,  Wisconsin,  53405,  United States
      Southern Wisconsin Radiotherapy Center, Madison,  Wisconsin,  53713,  United States
      St. Joseph's Hospital, Milwaukee,  Wisconsin,  53210,  United States
      St. Luke's Medical Center, Milwaukee,  Wisconsin,  53215,  United States
      St. Vincent Hospital, Green Bay,  Wisconsin,  54307-3508,  United States
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792,  United States
      Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee,  Wisconsin,  53295,  United States
      Waukesha Memorial Hospital, Waukesha,  Wisconsin,  53188,  United States
Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada
      Tom Baker Cancer Center - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada
Canada, New Brunswick
      Doctor Leon Richard Oncology Centre, Moncton,  New Brunswick,  E1C 8X3,  Canada
      Saint John Regional Hospital, Saint John,  New Brunswick,  E2L 4L2,  Canada
Canada, Nova Scotia
      Nova Scotia Cancer Centre, Halifax,  Nova Scotia,  B3H 1V7,  Canada
Canada, Ontario
      Cancer Care Ontario-Hamilton Regional Cancer Centre, Hamilton,  Ontario,  L8V 5C2,  Canada
      Cancer Care Ontario-London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada
      Kingston Regional Cancer Centre, Kingston,  Ontario,  K7L 5P9,  Canada
      Northeastern Ontario Regional Cancer Centre, Sudbury, Sudbury,  Ontario,  P3E 5J1,  Canada
      Northwestern Ontario Regional Cancer Centre, Thunder Bay, Thunder Bay,  Ontario,  P7A 7T1,  Canada
      Ottawa Regional Cancer Centre - Civic Campus, Ottawa,  Ontario,  K1Y 4K7,  Canada
      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2M9,  Canada
      Toronto Sunnybrook Regional Cancer Centre, Toronto,  Ontario,  M4N 3M5,  Canada
Canada, Quebec
      McGill University Department of Oncology, Montreal,  Quebec,  H2W 1S6,  Canada
Canada, Saskatchewan
      Saskatoon Cancer Centre, Saskatoon,  Saskatchewan,  S7N 4H4,  Canada

Study chairs or principal investigators

James D. Cox,  Study Chair,  Radiation Therapy Oncology Group   

Study ID Numbers:  CDR0000063854; RTOG-3D/OG-9406
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002602
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08