Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

A Phase III Trial to Evaluate the Duration of Neoadjuvant Total Androgen Suppression (TAS) and Radiation Therapy (RT) in Intermediate-Risk Prostate Cancer

RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Casodex; Drug: Eulexin; Drug: LHRH agonist; Radiation: radiation therapy

Detailed Description

OBJECTIVES:

• Compare the efficacy of moderate-duration (28 weeks) neoadjuvant total androgen suppression (TAS) and radiotherapy (RT) with short-duration (8 weeks) neoadjuvant TAS and RT, as related to disease-specific survival, in patients with intermediate-risk adenocarcinoma of the prostate.
• Compare these regimens, in terms of overall survival, disease-free survival, time to local tumor progression or distant failure, time to first biochemical failure, hormone-refractory state, and treatment-induced morbidity, in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prostate-specific antigen level (no greater than 10 ng/mL vs greater than 10 but no greater than 20 ng/mL vs greater than 20 ng/mL), tumor stage (T1b-2 vs T3-4), Gleason score (2-4 vs 5-6 vs 7-10), and prior hormonal therapy (yes vs no). Patients are randomized to one of two treatment arms.

• Arm I: Patients receive total androgen suppression for 8 weeks prior to the initiation of radiotherapy and throughout radiotherapy. A luteinizing hormone-releasing hormone (LHRH) agonist is administered every 1-3 months AND bicalutamide OR flutamide is given orally daily for a total duration of 16 weeks. Beginning with week 9, patients undergo radiotherapy 5 days a week for 8 weeks.
• Arm II: Patients receive total androgen suppression for 28 weeks prior to the initiation of radiotherapy and throughout radiotherapy. An LHRH agonist AND bicalutamide OR flutamide are administered as in arm I for a total duration of 36 weeks. Beginning with week 29, patients undergo radiotherapy as in arm I.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,540 patients (770 per treatment arm) will be accrued for this study within 4 years.

• Study Type: Interventional
• Enrollment (Actual): 1579
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Center - Calgary
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 8X3
      • Doctor Leon Richard Oncology Centre
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Saint John Regional Hospital
  • Newfoundland and Labrador
    • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
      • Newfoundland Cancer Treatment and Research Foundation
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Nova Scotia Cancer Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Margaret and Charles Juravinski Cancer Centre
    • Kingston, Ontario, Canada, K7L 5P9
      • Kingston Regional Cancer Centre
    • London, Ontario, Canada, N6A 4L6
      • Cancer Care Ontario-London Regional Cancer Centre
    • Ottawa, Ontario, Canada, K1H 1C4
      • Ottawa Regional Cancer Centre
    • Sudbury, Ontario, Canada, P3E 5J1
      • Northeastern Ontario Regional Cancer Centre - Sudbury
    • Thunder Bay, Ontario, Canada, P7B 6V4
      • Northwestern Ontario Regional Cancer Care
    • Toronto, Ontario, Canada, M4N 3M5
      • Toronto Sunnybrook Regional Cancer Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital
  • Quebec
    • Fleurimont, Quebec, Canada, J1H 5N4
      • CHUS-Hopital Fleurimont
    • Montreal, Quebec, Canada, H2W 1S6
      • McGill University
    • Montreal, Quebec, Canada, H2L 4MI
      • Centre Hospitalier de l'Universite de Montreal
    • Quebec City, Quebec, Canada, G1R 2J6
      • Centre Hospitalier Universitaire de Quebec
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Allan Blair Cancer Centre
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-3300
      • University of Alabama at Birmingham Comprehensive Cancer Center
    • Huntsville, Alabama, United States, 35801
      • Comprehensive Cancer Institute
    • Huntsville, Alabama, United States, 35807
      • Huntsville Hospital
    • Mobile, Alabama, United States, 36607
      • MBCCOP - Gulf Coast
    • Montgomery, Alabama, United States, 36106-3657
      • Montgomery Cancer Center
    • Tuscaloosa, Alabama, United States, 35401
      • DCH Cancer Treatment Center
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Foundation for Cancer Research and Education
  • California
    • Burbank, California, United States, 91505
      • Providence Saint Joseph Medical Center - Burbank
    • Concord, California, United States, 94524-4110
      • Mount Diablo Medical Center
    • Duarte, California, United States, 91010-3000
      • City of Hope Comprehensive Cancer Center
    • Fresno, California, United States, 93720
      • California Cancer Center
    • Fresno, California, United States, 93720
      • Saint Agnes Cancer Center
    • Greenbrae, California, United States, 94904
      • Sutter Health Western Division Cancer Research Group
    • Loma Linda, California, United States, 92354
      • Loma Linda University Cancer Institute at Loma Linda University Medical Center
    • Long Beach, California, United States, 90822
      • Veterans Affairs Medical Center - Long Beach
    • Los Angeles, California, United States, 90033-0804
      • USC/Norris Comprehensive Cancer Center and Hospital
    • Los Angeles, California, United States, 90095-1714
      • Jonsson Comprehensive Cancer Center, UCLA
    • Oakland, California, United States, 94609-3305
      • CCOP - Bay Area Tumor Institute
    • Pasadena, California, United States, 91105
      • Huntington Cancer Center at Huntington Hospital
    • Pomona, California, United States, 91767
      • Robert and Beverly Lewis Family Cancer Care Center
    • Sacramento, California, United States, 95816
      • Radiation Oncology Center - Sacramento
    • San Diego, California, United States, 92134-3202
      • Naval Medical Center - San Diego
    • San Diego, California, United States, 92101
      • Radiation Medical Group, Incorporated
    • San Francisco, California, United States, 94115
      • UCSF Comprehensive Cancer Center
    • San Jose, California, United States, 95128
      • O'Connor Hospital
    • Santa Rosa, California, United States, 95403
      • CCOP - Santa Rosa Memorial Hospital
    • Torrance, California, United States, 90505
      • Torrance Memorial Medical Center
    • Travis Air Force Base, California, United States, 94535
      • David Grant Medical Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Memorial Hospital Cancer Center
    • Denver, Colorado, United States, 80010
      • University of Colorado Cancer Center at University of Colorado Health Sciences Center
    • Denver, Colorado, United States, 80224
      • CCOP - Colorado Cancer Research Program, Incorporated
    • Grand Junction, Colorado, United States, 81502-1628
      • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Hospital of St. Raphael
    • New Haven, Connecticut, United States, 06520-8040
      • Yale Comprehensive Cancer Center
  • Delaware
    • Newark, Delaware, United States, 19713
      • CCOP - Christiana Care Health Services
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Sibley Memorial Hospital
  • Florida
    • Fort Myers, Florida, United States, 33901-8082
      • 21st Century Oncology - Fort Myers
    • Gainesville, Florida, United States, 32610-0385
      • Shands Cancer Center at the University of Florida Health Science Center
    • Jacksonville, Florida, United States, 32207
      • Florida Radiation Oncology Group
    • Melbourne, Florida, United States, 32901-3276
      • Holmes Regional Medical Center
    • Miami, Florida, United States, 33136
      • University of Miami Sylvester Cancer Center
    • Miami, Florida, United States, 33256-2110
      • Baptist Hospital of Miami
    • Miami Beach, Florida, United States, 33140
      • CCOP - Mount Sinai Medical Center
    • Orlando, Florida, United States, 32806-2134
      • MD Anderson Cancer Center Orlando
    • Panama City, Florida, United States, 32405-4587
      • Gulf Coast Cancer Treatment Center
    • Panama City, Florida, United States, 32401
      • Bay Medical Center
    • Sarasota, Florida, United States, 34233
      • Sarasota Radiation and Medical Oncology Center
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
    • Tampa, Florida, United States, 33612-9497
      • H. Lee Moffitt Cancer Center and Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute of Emory University
    • Atlanta, Georgia, United States, 30342-1701
      • CCOP - Atlanta Regional
    • Columbus, Georgia, United States, 31901
      • Medical Center/John B. Amos Community Cancer Center
    • Rome, Georgia, United States, 30165
      • Regional Radiation Oncology Center at Rome
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • MBCCOP - Hawaii
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Northwest Community Hospital
    • Chicago, Illinois, United States, 60611-3013
      • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
    • Decatur, Illinois, United States, 62526
      • CCOP - Central Illinois
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital
    • Maywood, Illinois, United States, 60153
      • Cardinal Bernardin Cancer Center at Loyola University Medical Center
    • Park Ridge, Illinois, United States, 60068
      • Lutheran General Cancer Care Center
    • Peoria, Illinois, United States, 61636
      • Methodist Medical Center of Illinois
    • Peoria, Illinois, United States, 61602
      • CCOP - Scott and White Hospital
  • Indiana
    • Anderson, Indiana, United States, 46016
      • St. John's Medical Center
    • Bloomington, Indiana, United States, 47402
      • Bloomington Hospital
    • Indianapolis, Indiana, United States, 46202
      • Veterans Affairs Medical Center - Indianapolis (Roudebush)
    • Indianapolis, Indiana, United States, 46206-1367
      • Methodist Cancer Center at Methodist Hospital
    • Indianapolis, Indiana, United States, 46219
      • Community Regional Cancer Care
    • Muncie, Indiana, United States, 47303-3499
      • Ball Memorial Hospital Cancer Center
    • South Bend, Indiana, United States, 46601
      • CCOP - Northern Indiana CR Consortium
  • Iowa
    • Dubuque, Iowa, United States, 52001
      • Wendt Regional Cancer Center of Finley Hospital
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • St. Elizabeth Medical Center
    • Lexington, Kentucky, United States, 40503
      • Central Baptist Hospital
    • Lexington, Kentucky, United States, 40536-0293
      • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Louisville, Kentucky, United States, 40202
      • James Graham Brown Cancer Center at University of Louisville
    • Louisville, Kentucky, United States, 40215
      • Louisville Radiation Oncology Center at Caritas Regional Cancer Center
    • Madisonville, Kentucky, United States, 42431
      • Merle M. Mahr Cancer Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Mary Bird Perkins Cancer Center
    • New Orleans, Louisiana, United States, 70121
      • CCOP - Ochsner
    • New Orleans, Louisiana, United States, 70112
      • MBCCOP - LSU Health Sciences Center
    • New Orleans, Louisiana, United States, 70112-2699
      • Tulane University School of Medicine
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Oncology Center
    • Baltimore, Maryland, United States, 21231-2410
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital of Baltimore
    • Baltimore, Maryland, United States, 21201
      • Marlene and Stewart Greenebaum Cancer Center, University of Maryland
    • Baltimore, Maryland, United States, 21204
      • Greater Baltimore Medical Center and Cancer Center
    • Baltimore, Maryland, United States, 21215-1290
      • Harbor Hospital Center
    • Baltimore, Maryland, United States, 21229
      • St. Agnes Cancer Center
    • Salisbury, Maryland, United States, 21801
      • Peninsula Regional Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Cancer Research Center at Boston Medical Center
    • Boston, Massachusetts, United States, 02114
      • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
    • Hyannis, Massachusetts, United States, 02601
      • Cape Cod Hospital
    • Jamaica Plain, Massachusetts, United States, 02130
      • Veterans Affairs Medical Center - Boston (Jamaica Plain)
    • Peabody, Massachusetts, United States, 01960
      • NSMC Cancer Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • CCOP - Michigan Cancer Research Consortium
    • Ann Arbor, Michigan, United States, 48109-0010
      • University of Michigan Comprehensive Cancer Center
    • Detroit, Michigan, United States, 48202
      • Josephine Ford Cancer Center at Henry Ford Hospital
    • Detroit, Michigan, United States, 48201-1379
      • Barbara Ann Karmanos Cancer Institute
    • Flint, Michigan, United States, 48503
      • Hurley Medical Center
    • Flint, Michigan, United States, 48532-3685
      • McLaren Regional Cancer Center
    • Kalamazoo, Michigan, United States, 49007-3731
      • CCOP - Kalamazoo
    • Marquette, Michigan, United States, 49855
      • Marquette General Hospital
    • Midland, Michigan, United States, 48670
      • MidMichigan Medical Center - Midland
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital - Royal Oak
    • Royal Oak, Michigan, United States, 48073-6769
      • CCOP - Beaumont
    • Troy, Michigan, United States, 48085
      • William Beaumont Hospital - Troy
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Fairview University Medical Center - University Campus
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic Cancer Center
    • Saint Louis Park, Minnesota, United States, 55416
      • CCOP - Metro-Minnesota
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Ellis Fischel Cancer Center at University of Missouri - Columbia
    • Kansas City, Missouri, United States, 64131
      • CCOP - Kansas City
    • Saint Louis, Missouri, United States, 63110
      • Mallinckrodt Institute of Radiology
    • Saint Louis, Missouri, United States, 63110-0250
      • St. Louis University Hospital Cancer Center
    • Springfield, Missouri, United States, 65807
      • CCOP - Cancer Research for the Ozarks
    • Springfield, Missouri, United States, 65807
      • Cancer Research for the Ozarks
  • Montana
    • Billings, Montana, United States, 59101
      • CCOP - Montana Cancer Consortium
  • Nebraska
    • Omaha, Nebraska, United States, 68106
      • CCOP - Missouri Valley Cancer Consortium
    • Omaha, Nebraska, United States, 68114-4199
      • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
    • Omaha, Nebraska, United States, 68198-7521
      • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • CCOP - Southern Nevada Cancer Research Foundation
    • Las Vegas, Nevada, United States, 89109
      • Comprehensive Cancer Centers of Nevada
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756-0002
      • Norris Cotton Cancer Center at Dartmouth Medical School
    • Manchester, New Hampshire, United States, 03103
      • Elliot Regional Cancer Center
  • New Jersey
    • Camden, New Jersey, United States, 01803
      • Cooper Cancer Institute
    • East Orange, New Jersey, United States, 07019
      • Veterans Affairs Medical Center - East Orange
    • Edison, New Jersey, United States, 08818
      • John F. Kennedy Medical Center
    • Elizabeth, New Jersey, United States, 07201
      • Trinitas Hospital - Jersey Street Campus
    • Long Branch, New Jersey, United States, 07740-6395
      • Monmouth Medical Center
    • Millville, New Jersey, United States, 08332
      • South Jersey Regional Cancer Center
    • Mount Holly, New Jersey, United States, 08060
      • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
    • New Brunswick, New Jersey, United States, 08903
      • Cancer Institute Of New Jersey
    • Newark, New Jersey, United States, 07112
      • Newark Beth Israel Medical Center
    • Pomona, New Jersey, United States, 08240
      • Atlantic City Medical Center
    • Princeton, New Jersey, United States, 08540
      • Medical Center of Princeton
    • Ridgewood, New Jersey, United States, 07450
      • Valley Hospital
    • Somerville, New Jersey, United States, 08876
      • Somerset Medical Center
    • Toms River, New Jersey, United States, 08755
      • Community Medical Center
    • Trenton, New Jersey, United States, 08629
      • Fox Chase Cancer Center at St. Francis Medical Center
    • Warren, New Jersey, United States, 07059
      • Associated Radiologists, P.A.
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Radiation Oncology Associates of Albuquerque
  • New York
    • Albany, New York, United States, 12208
      • Cancer Center of Albany Medical Center
    • Brooklyn, New York, United States, 11203
      • State University of New York Health Science Center at Brooklyn
    • Brooklyn, New York, United States, 11215
      • New York Methodist Hospital
    • Buffalo, New York, United States, 14263-0001
      • Roswell Park Cancer Institute
    • Clifton Springs, New York, United States, 14432
      • Finger Lakes Radiation Oncology Center
    • Manhasset, New York, United States, 11030
      • CCOP - North Shore University Hospital
    • New York, New York, United States, 10032
      • Herbert Irving Comprehensive Cancer Center at Columbia University
    • New York, New York, United States, 10003
      • Beth Israel Medical Center - Philipps Ambulatory Care Center
    • Plattsburgh, New York, United States, 12901-1490
      • Champlain Valley Physicians Hospital Medical Center
    • Rochester, New York, United States, 14642
      • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • Syracuse, New York, United States, 13217
      • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
    • Yonkers, New York, United States, 10701
      • Riverhill Radiation Oncology
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7295
      • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
    • Concord, North Carolina, United States, 28025
      • Batte Cancer Center at Northeast Medical Center
    • Greenville, North Carolina, United States, 27835-6028
      • Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
    • Winston-Salem, North Carolina, United States, 27104-4241
      • CCOP - Southeast Cancer Control Consortium
    • Winston-Salem, North Carolina, United States, 27157-1082
      • Comprehensive Cancer Center at Wake Forest University
  • North Dakota
    • Minot, North Dakota, United States, 58701
      • Trinity Cancer Care Center
  • Ohio
    • Akron, Ohio, United States, 44302
      • Akron General Medical Center
    • Akron, Ohio, United States, 44304
      • Akron City Hospital
    • Cincinnati, Ohio, United States, 45219
      • Cancer Center at Christ Hospital
    • Cincinnati, Ohio, United States, 45219
      • Charles M. Barrett Cancer Center at University Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Center
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland
    • Cleveland, Ohio, United States, 44106-5065
      • Ireland Cancer Center
    • Columbus, Ohio, United States, 43210-1240
      • Arthur G. James Cancer Hospital - Ohio State University
    • Columbus, Ohio, United States, 43206
      • CCOP - Columbus
    • Dayton, Ohio, United States, 45429
      • CCOP - Dayton
    • Parma, Ohio, United States, 44129
      • Parma Community General Hospital
    • Toledo, Ohio, United States, 43623-3456
      • CCOP - Toledo Community Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
    • Oklahoma City, Oklahoma, United States, 73102
      • Frank C. Love Cancer Institute at St. Anthony Hospital
    • Tulsa, Oklahoma, United States, 74136
      • CCOP - Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • St. John Health System
  • Oregon
    • Portland, Oregon, United States, 97225
      • CCOP - Columbia River Oncology Program
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Memorial Hospital
    • Allentown, Pennsylvania, United States, 18105
      • John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's Hospital Cancer Center
    • Danville, Pennsylvania, United States, 17822-2001
      • Geisinger Medical Center
    • Darby, Pennsylvania, United States, 19023
      • Mercy Fitzgerald Hospital
    • Drexel Hill, Pennsylvania, United States, 19026
      • Delaware County Memorial Hospital
    • East Stroudsburg, Pennsylvania, United States, 18301
      • Pocono Cancer Center
    • Hershey, Pennsylvania, United States, 17033-0850
      • Penn State Cancer Institute at Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Veterans Affairs Medical Center - Philadelphia
    • Philadelphia, Pennsylvania, United States, 19107-5541
      • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
    • Philadelphia, Pennsylvania, United States, 19104-4283
      • Abramson Cancer Center at University of Pennsylvania Medical Center
    • Philadelphia, Pennsylvania, United States, 19141-3098
      • Albert Einstein Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • Pittsburgh, Pennsylvania, United States, 15224
      • Western Pennsylvania Hospital
    • Pittsburgh, Pennsylvania, United States, 15219
      • Mercy Hospital of Pittsburgh
    • Pittsburgh, Pennsylvania, United States, 15236
      • Hillman Cancer Center at University of Pittsburgh Cancer Institute
    • Reading, Pennsylvania, United States, 19612-6052
      • Reading Hospital and Medical Center
    • Scranton, Pennsylvania, United States, 18501
      • Mercy Hospital Cancer Center - Scranton
    • Wilkes-Barre, Pennsylvania, United States, 18764-0001
      • Wilkes-Barre General Hospital
    • Wynnewood, Pennsylvania, United States, 19096
      • CCOP - MainLine Health
    • York, Pennsylvania, United States, 17403
      • Wellspan Health - York Cancer Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02908-4735
      • Roger Williams Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • CCOP - Greenville
    • Spartanburg, South Carolina, United States, 29303
      • CCOP - Upstate Carolina
  • South Dakota
    • Rapid City, South Dakota, United States, 57709
      • Rapid City Regional Hospital
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • West Tennessee Cancer Center at Jackson-Madison County General Hospital
    • Nashville, Tennessee, United States, 37232-5671
      • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
  • Texas
    • Amarillo, Texas, United States, 79106
      • Harrington Cancer Center
    • Arlington, Texas, United States, 76012
      • Arlington Cancer Center
    • Galveston, Texas, United States, 77555-0209
      • University of Texas Medical Branch
    • Houston, Texas, United States, 77030-4009
      • University of Texas - MD Anderson Cancer Center
    • Lackland Air Force Base, Texas, United States, 78236-5300
      • Wilford Hall Medical Center
    • Lubbock, Texas, United States, 79410-1894
      • Joe Arrington Cancer Research and Treatment Center
    • Pasadena, Texas, United States, 77504
      • Bayshore Medical Center
    • San Antonio, Texas, United States, 78284-7811
      • University of Texas Health Science Center at San Antonio
  • Utah
    • Provo, Utah, United States, 84604
      • Utah Valley Regional Medical Center - Provo
    • Saint George, Utah, United States, 84770
      • Dixie Regional Medical Center
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health Sciences Center
    • Salt Lake City, Utah, United States, 84143
      • LDS Hospital
  • Vermont
    • Bennington, Vermont, United States, 05201
      • Green Mountain Oncology Group
    • Burlington, Vermont, United States, 05405-0075
      • Vermont Cancer Center at University of Vermont
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Cancer Center at the University of Virginia
    • Harrisonburg, Virginia, United States, 22801
      • RMH Regional Cancer Center
    • Portsmouth, Virginia, United States, 23708-2197
      • Naval Medical Center, Portsmouth
    • Richmond, Virginia, United States, 23226
      • Bon Secours - St. Mary's Hospital
    • Richmond, Virginia, United States, 23298-0058
      • Massey Cancer Center at Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States, 98195-6043
      • University Cancer Center at University of Washington Medical Center
    • Seattle, Washington, United States, 98111
      • Cancer Institute at Virginia Mason Medical Center
    • Spokane, Washington, United States, 99204
      • Deaconess Medical Center
    • Yakima, Washington, United States, 98902
      • Yakima Valley Memorial Hospital
  • West Virginia
    • Wheeling, West Virginia, United States, 26003
      • Schiffler Cancer Center
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • CCOP - St. Vincent Hospital Cancer Center, Green Bay
    • Green Bay, Wisconsin, United States, 54307-3508
      • St. Vincent Hospital
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Comprehensive Cancer Center
    • Madison, Wisconsin, United States, 53713
      • Southern Wisconsin Radiotherapy Center
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Clinic
    • Marshfield, Wisconsin, United States, 54449
      • CCOP - Marshfield Clinic Research Foundation
    • Menomonee Falls, Wisconsin, United States, 53051
      • Community Memorial Hospital
    • Milwaukee, Wisconsin, United States, 53211
      • Columbia Hospital
    • Milwaukee, Wisconsin, United States, 53215
      • St. Luke's Medical Center
    • Milwaukee, Wisconsin, United States, 53295
      • Veterans Affairs Medical Center - Milwaukee (Zablocki)
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin Cancer Center
    • Racine, Wisconsin, United States, 53405
      • All Saints Cancer Center at All Saints Healthcare
    • Waukesha, Wisconsin, United States, 53188
      • Waukesha Memorial Hospital Regional Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria

1. Adenocarcinoma of prostatic origin histologically-confirmed within 180 days of the randomization date.
2. Zubrod Performance Status 0-1 (Appendix II).
3. Prostatic biopsy tumor grading by the Gleason Score classification (Appendix VI) is mandatory prior to randomization.

4. Patients at intermediate risk for disease relapse as determined by any of the following combinations of factors (NOTE: tumor found in one or both lobes on biopsy, but not palpable, will not alter T stage):

   • Clinical stage T1b-4, Gleason score 2-6, and prostate-specific antigen >10 but ≤ 100.
   • Clinical stage T1b-4, Gleason score 7, and prostate-specific antigen < 20.
   • Clinical stage T1b-1c, Gleason score 8-10, and prostate-specific antigen <20.
5. Clinically negative (N0) lymph nodes (LN) as established by imaging (pelvic ± abdominal CT, MRI or LAG), or negative LN by nodal sampling or dissection (laparoscopy or laparotomy). Patients with radiologic (e.g., CT, MRI or LAG) or radioimmunoscintigraphy (i.e., ProstaScint™) findings suggestive of regional nodal involvement are eligible if cytologic (e.g., needle aspiration) or histologic (e.g., surgical sampling) evaluation shows no evidence of a neoplastic process (i.e., prostatic or non-prostatic malignancy). Patients with equivocal radiologic findings (maximum nodal size ≤ 1.5 cm) are eligible.
6. No distant (M0) metastases. Patients with radionuclide imaging (e.g., bone scintigraphy, ProstaScint™) findings suggestive, but not diagnostic of metastatic disease are eligible if radiologic (e.g., standard or tomographic radiography, or CT/MRI) imaging does not confirm metastatic disease.
7. Pretherapy serum (total) prostate-specific antigen value performed with a Federal Drug Administration approved assay method, e.g. Abbott, Hybritech, etc.
8. Treatment must begin within 6 weeks after randomization.
9. Alanine aminotransferase (ALT) must be within 2 x upper normal limit.
10. Patients must sign a study-specific informed consent form (Appendix I) prior to randomization.

Exclusion Criteria

1. Patients at high risk for disease relapse as determined by either:

   • Prostate-specific antigen ≥ 20 and Gleason score ≥ 7 (any T stage).
   • Clinical stage ≥T2 and Gleason score ≥ 8 (any prostate-specific antigen).

2. Patients at low risk for disease relapse as determined by:

   • Clinical stage ≤T2, Gleason score ≤ 6, and prostate-specific antigen ≤ 10.

3. Clinical stage Tx, T0, or T1a.
4. Histologic or radiologic evidence of tumor involvement of regional lymph nodes (N1) or the presence of metastatic disease (M1).
5. Pretherapy serum prostate-specific antigen level > 100.
6. Co-morbid medical illness which in the opinion of the investigator is expected to result in a life expectancy of <10 years.

7. Any of the following prior therapies:

   • Pelvic external beam radiation therapy.
   • Radionuclide prostate brachytherapy.
   • Prostatectomy or prostatic cryosurgery.
   • Prior bilateral orchiectomy.
   • Prior androgen suppression therapy; however, patients begun on LHRH agonist therapy remain eligible if (1) LHRH agonists were started no more than 30 days before randomization, and (2) Casodex or Eulexin was (or will be) started no more than 14 days before or after the date that the LHRH agonist injection was given. Any finasteride therapy administered for prostatic hypertrophy must be discontinued.
   • Chemotherapy for prostatic carcinoma.
8. Previous or concomitant invasive cancer, other than localized basal cell or squamous cell skin carcinoma (AJCC Stage 0-II), unless continually disease free for at least 5 years.
9. Major medical or psychiatric illness which, in the opinion of the investigator, would prevent completion of treatment or would interfere with follow-up.
10. The patient's participation in another medical research study that involves prostate cancer treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAS x 8 weeks; Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).	Drug: Casodex; Orally at a dose of one 50 mg tablet per day started within (before or after) 14 days of the first LHRH agonist injection.; Other Names: bicalutamide; Drug: Eulexin; Orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg (six capsules) started within (before or after) 14 days of the first LHRH agonist injection.; Other Names: flutamide; Drug: LHRH agonist; LHRH agonist of choice. The manufacturer's instructions should be followed.; Other Names: Lupron; Zoladex; Eligard; Viadur; luteinizing hormone-releasing hormone (LHRH)-agonist; Radiation: radiation therapy; [Prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin receives 70.2 Gy (1.8 Gy/day x 39 fractions, five days/week)] OR [regional nodes, prostate and seminal vesicles + 1.0-1.5 cm margin will receive 46.8 Gy (1.8 Gy/day x 26 fractions, five days/week), followed by a 23.4 Gy (1.8 Gy/day x 13 fractions, five days/week) boost to the prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin]
Experimental: TAS x 28 weeks; TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).	Drug: Casodex; Orally at a dose of one 50 mg tablet per day started within (before or after) 14 days of the first LHRH agonist injection.; Other Names: bicalutamide; Drug: Eulexin; Orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg (six capsules) started within (before or after) 14 days of the first LHRH agonist injection.; Other Names: flutamide; Drug: LHRH agonist; LHRH agonist of choice. The manufacturer's instructions should be followed.; Other Names: Lupron; Zoladex; Eligard; Viadur; luteinizing hormone-releasing hormone (LHRH)-agonist; Radiation: radiation therapy; [Prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin receives 70.2 Gy (1.8 Gy/day x 39 fractions, five days/week)] OR [regional nodes, prostate and seminal vesicles + 1.0-1.5 cm margin will receive 46.8 Gy (1.8 Gy/day x 26 fractions, five days/week), followed by a 23.4 Gy (1.8 Gy/day x 13 fractions, five days/week) boost to the prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-specific Survival (DSS) (10-year Rates Reported)	Disease-specific survival time is measured from date of randomization to death due to prostate cancer based on study chair review, with prostate-cancer death defined as (1) primary cause of death certified as due to prostate cancer, (2) complication of therapy, irrespective of disease status, (3) disease progression in the absence of any anti-tumor therapy, or (4) a 1.0 ng/ml-exceeding-rise in serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy. Death due to other causes is considered a competing risk. All others are censored. DSS is estimated using the cumulative incidence method. Ten-year rate is reported.	From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) (10-year Rates Reported)	Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.	From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
Disease-free Survival (DFS) (10-year Rates Reported)	Disease-free survival time is defined as time from randomization to the date of disease progression or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.	From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported)	Time to distant metastasis measured from date of randomization to date of documented distant metastasis; competing risks are BF, LRP, and death without DM; all others are censored. Time to locoregional progression measured from date of randomization to date of documented local or regional progression; competing risks are BF [protocol definition- first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy], DM, and death without LRP; all others are censored. LRP and DM are estimated using the cumulative incidence method. Ten -year rates are reported.	From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
Time to First Biochemical Failure (BF) (10-year Rates Reported)	Protocol definition: Time to BF measured from date of randomization to first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. Phoenix definition: Time to BF measured from date of randomization to first of (1) the date of documented rise of 2 ng/ml above the post-treatment(RT end date) nadir or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. For both definitions BF is estimated using the cumulative incidence method. Ten year rates reported.	From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
Time to Second Biochemical Failure (SBF) (10-year Rates Reported)	Time to SBF measured from date of randomization to the date of PSA increase of ≥1.0 ng/mL (from the nadir PSA after completion of protocol-specified therapy) after salvage androgen suppression was started; competing risks LRP, DM, and death without SBF; all others are censored. SBF is estimated using the cumulative incidence method. Ten-year rates are reported.	From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)	Acute drug therapy and radiation (<= 90 days from start of RT) toxicity was graded using the Common Toxicity Criteria (CTC) v.2.0 criteria; late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring schema. Grade refers to the severity of the toxicity. The CTC v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild toxicity, Grade 2 Moderate toxicity, Grade 3 Severe toxicity, Grade 4 Life-threatening or disabling toxicity, Grade 5 Death related to toxicity. The highest grade acute and late toxicity was determined for each patient.	From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

Collaborators and Investigators

• Sponsor: Radiation Therapy Oncology Group
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• Pisansky TM, Hunt D, Gomella LG, Amin MB, Balogh AG, Chinn DM, Seider MJ, Duclos M, Rosenthal SA, Bauman GS, Gore EM, Rotman MZ, Lukka HR, Shipley WU, Dignam JJ, Sandler HM. Duration of androgen suppression before radiotherapy for localized prostate cancer: radiation therapy oncology group randomized clinical trial 9910. J Clin Oncol. 2015 Feb 1;33(4):332-9. doi: 10.1200/JCO.2014.58.0662. Epub 2014 Dec 22.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2000
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): May 20, 2022

Study Registration Dates

• First Submitted: April 6, 2000
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: stage III prostate cancer; adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Androgen Antagonists; Hormones; Bicalutamide; Flutamide; Prolactin Release-Inhibiting Factors
• Other Study ID Numbers: RTOG-9910; CDR0000067635