This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00002597
First received: November 1, 1999
Last updated: May 8, 2017
Last verified: May 2017
  Purpose

RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.


Condition Intervention Phase
Prostate Cancer Drug: flutamide Drug: Zoladex Drug: Lupron Radiation: radiation therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A PHASE III TRIAL OF THE STUDY OF ENDOCRINE THERAPY USED AS A CYTOREDUCTIVE AND CYTOSTATIC AGENT PRIOR TO RADIATION THERAPY IN GOOD PROGNOSIS LOCALLY CONFINED ADENOCARCINOMA OF THE PROSTATE

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall Survival Rate (10-year) [ Time Frame: From date of randomization to 10 years ]
    Overall survival (OS) was calculated from randomization to the date of death from any cause and overall survival rates were estimated by the Kaplan-Meier method.


Secondary Outcome Measures:
  • Disease-specific Survival Rate (10 Years) [ Time Frame: From registration to 10 years ]
    Disease-specific failure is defined as death certified as due to prostate cancer (by central review), death due to complications of treatment (irrespective of malignancy status), death from unknown causes with active malignancy, or death from unknown causes with previously documented relapse (either clinical or biochemical). Survival rates were estimated by means of cumulative incidence functions.

  • Local Progression Rate (10 Years) [ Time Frame: From registration to 10 years ]
    Local progression defined as documented local progression as determined by clinical exam . Failure rates were estimated by means of cumulative incidence functions.

  • Distant Failure Rate (10 Years) [ Time Frame: From registration to 10 years ]
    Failure is defined as documented metastatic disease. Failure rates were estimated by means of cumulative incidence functions.

  • Biochemical Failure Rate (10 Years) [ Time Frame: From registration to 10 years ]
    The Phoenix definition of biochemical failure was used - an increase in the prostate-specific antigen (PSA) level of >2 ng per milliliter above the nadir. Failure rates were estimated by means of cumulative incidence functions.

  • Clinical Relapse Rate (10 Years) [ Time Frame: From registration to 10 years ]
    Clinical relapse is defined as local progression or distant metastases. Failure rates were estimated by means of cumulative incidence functions.

  • Second Biochemical Relapse Rate (10 Years) [ Time Frame: From registration to 10 years ]
    Second biochemical relapse is as defined as follows (after initiation of salvage hormone therapy): A rise in PSA on at least two consecutive cases above the nadir (after initiation of salvage hormone therapy), with the rises in PSA exceeding 1 ng/ml above the nadir; or failure to reach 4 ng/L or less at 18 months. The rates of second biochemical relapse were estimated by means of cumulative incidence functions.

  • Disease-free Survival Rate (10 Years) [ Time Frame: From registration to 10 years ]
    Disease-free failure is defined as documentation of progression (local progression, distant failure, and biochemical failure) or death from any cause. Disease-free survival rates were estimated by the Kaplan-Meier method.

  • Positive Re-biopsy Rate at Two Years [ Time Frame: From registration to two years ]
    The rate of prostate rebiopsy at two years is defined as the proportion of patients whose results are positive among all eligible patients who had a repeat biopsy at two years. The rate was estimated separately in each arm.


Enrollment: 2028
Study Start Date: October 1994
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neoadjuvant TAS + RT
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
Drug: flutamide
Two 125 mg capsules (t.i.d., p.o.) beginning two months before RT and continuing until RT is completed.
Other Name: Eulexin
Drug: Zoladex
3.6 mg s.c. monthly x 4 beginning two months before RT and continuing until RT is completed. The 3-month preparation may be used instead of three separate monthly injections.
Other Name: goserelin acetate
Drug: Lupron
7.5 mg IM (intramuscular) monthly x 4 beginning two months before RT and continuing until RT is completed. The 3-month preparation may be used instead of three separate monthly injections.
Other Name: leuprolide acetate
Radiation: radiation therapy
46.8 Gy (1.8 Gy/day four to five times a week [26 fx]) to regional lymphatics followed by 19.8 Gy (1.8 Gy/day x 11 fx) for a total of 66.6 Gy to the prostate. Prostate only may be treated in defined circumstances.
Radiation therapy alone
Radiation therapy alone
Radiation: radiation therapy
46.8 Gy (1.8 Gy/day four to five times a week [26 fx]) to regional lymphatics followed by 19.8 Gy (1.8 Gy/day x 11 fx) for a total of 66.6 Gy to the prostate. Prostate only may be treated in defined circumstances.

Detailed Description:

OBJECTIVES: Primary: To evaluate whether a combination of Zoladex and flutamide used as cytoreductive agents prior to and during definitive radiation therapy improves overall survival over radiation therapy alone in locally confined carcinomas of the prostate; Secondary: To compare the rates of disease-specific survival, clinical relapse (local progression and/or distant failure), freedom from prostate-specific antigen (PSA) failure, freedom from second clinical relapse, freedom from second PSA relapse, and disease-free survival; To compare the prostate re-biopsy at two years; To measure the effect on sexual function.

OUTLINE: This is a randomized, multicenter study. Patients were stratified by PSA level (less than 4 vs 4-20), tumor differentiation (well vs moderate vs poor), nodal status (N0 [nodes evaluated by surgical sampling] vs NX [nodes evaluated negative by imaging methods only]), and participating center. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral flutamide 3 times a day and goserelin subcutaneously once every 4 weeks, or once as a time release injection (intramuscular leuprolide may be substituted for goserelin), beginning 2 months prior to radiotherapy and continuing until completion of radiotherapy. Patients undergo radiotherapy daily 4-5 days per week for almost 8 weeks. Arm II: Patients undergo radiotherapy only, as in arm I. Patients are followed every 3 months for the remainder of the first year, every 4 months for the second year, every 6 months for the third through fifth years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1980 patients within 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002597

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
Huntsville Hospital System
Huntsville, Alabama, United States, 35801-4470
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States, 35801
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
Alabama Oncology, LLC
Montgomery, Alabama, United States, 36106-2801
Radiation Oncology Associates of West Alabama
Tuscaloosa, Alabama, United States, 35401
United States, Alaska
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
Mount Diablo Medical Center
Concord, California, United States, 94524-4110
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
California Cancer Center
Fresno, California, United States, 93720
Saint Agnes Cancer Center
Fresno, California, United States, 93720
Glendale Memorial Hospital and Health Center
Glendale, California, United States, 91204
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States, 94904
University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0658
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States, 90822
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
Cancer Care Center
Pomona, California, United States, 91767
Radiation Oncology Center - Sacramento
Sacramento, California, United States, 95816
Radiation Medical Group, Inc.
San Diego, California, United States, 92101-1492
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
O'Connor Hospital
San Jose, California, United States, 95128
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
United States, Colorado
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States, 80909
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
United States, Delaware
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Walter Reed Army Medical Center
Washington, D.C., District of Columbia, United States, 20307-5000
United States, Florida
Lykes Center for Radiation Therapy
Clearwater, Florida, United States, 33757-0210
Halifax Medical Center
Daytona Beach, Florida, United States, 32114
Radiation Therapy Associates - Fort Myers
Fort Myers, Florida, United States, 33901
University of Florida Health Science Center
Gainesville, Florida, United States, 32610-0296
Health First Holmes Regional Medical Center
Melbourne, Florida, United States, 32901
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
dVeterans Affairs Medical Center - Miami
Miami, Florida, United States, 33125
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
Baptist Hospital of Miami
Miami, Florida, United States, 33176-2197
Florida Radiation Oncology Group
Orange Park, Florida, United States, 32073
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
Bay Medical Center
Panama City, Florida, United States, 32401
Gulf Coast Cancer Treatment Center
Panama City, Florida, United States, 32405-4587
Sarasota Radiation and Medical Oncology Center
Sarasota, Florida, United States, 34233
Tallahassee Memorial Healthcare
Tallahassee, Florida, United States, 32308
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Medical Center/John B. Amos Community Cancer Center
Columbus, Georgia, United States, 31902
InterCommunity Cancer Center at Rome
Rome, Georgia, United States, 30161
United States, Illinois
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
Provena St. Joseph Hospital- Regional Cancer Care Center
Elgin, Illinois, United States, 60123
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
United States, Indiana
St. John's Medical Center
Anderson, Indiana, United States, 46016
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
Clarion Health Partners Inc.
Indianapolis, Indiana, United States, 46206-1367
Community Hospitals of Indianapolis - Regional Cancer Center
Indianapolis, Indiana, United States, 46219
Ball Memorial Hospital
Muncie, Indiana, United States, 47303-3499
United States, Iowa
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, United States, 52001
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, Kentucky
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States, 40511-1093
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Louisville Radiation Oncology
Louisville, Kentucky, United States, 40215
Merle M. Mahr Cancer Center
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Romagosa Radiation Oncology Center
Lafayette, Louisiana, United States, 70501
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
Anne Arundel Oncology Center
Annapolis, Maryland, United States, 21401
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States, 21204
Harbor Hospital Center
Baltimore, Maryland, United States, 21225
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21225
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231-2410
Radiation Oncology Affiliates of Maryland, P.A.
Baltimore, Maryland, United States, 21237
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States, 02130
United States, Michigan
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Henry Ford Hospital
Detroit, Michigan, United States, 48202
McLaren Regional Cancer Center
Flint, Michigan, United States, 48432
Hurley Medical Center
Flint, Michigan, United States, 48503
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
Marquette General Hospital
Marquette, Michigan, United States, 49855
MidMichigan Medical Center - Midland
Midland, Michigan, United States, 48670
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
St. Mary's Medical Center
Saginaw, Michigan, United States, 48601
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Mississippi
North Mississippi Medical Center/Cancer Center
Tupelo, Mississippi, United States, 38801
United States, Missouri
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110-0250
Mallinckrodt Institute of Radiology
Saint Louis, Missouri, United States, 63110
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
Nebraska Health System
Omaha, Nebraska, United States, 68105-1018
Methodist Cancer Center - Omaha
Omaha, Nebraska, United States, 68114
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
Elliot Regional Cancer Center
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Cooper Cancer Institute
Camden, New Jersey, United States, 08103
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07018-1095
John F. Kennedy Medical Center
Edison, New Jersey, United States, 08818
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, United States, 07201
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
South Jersey Regional Cancer Center
Millville, New Jersey, United States, 08332
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, United States, 08060
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Atlantic City Medical Center
Pomona, New Jersey, United States, 08240
Community Medical Center
Toms River, New Jersey, United States, 08755
Capital Health System at Mercer
Trenton, New Jersey, United States, 08607
St. Francis Medical Center
Trenton, New Jersey, United States, 08629
Associated Radiologists, P.A.
Warren Township, New Jersey, United States, 07059
United States, New Mexico
Saint Joseph Medical Center
Albuquerque, New Mexico, United States, 87102
United States, New York
Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
New York Methodist Hospital
Brooklyn, New York, United States, 11215-3609
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Finger Lakes Radiation Oncology, P.C.
Clifton Springs, New York, United States, 14432
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Beth Israel Medical Center
New York, New York, United States, 10003
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States, 12901
Vassar Brothers Hospital
Poughkeepsie, New York, United States, 12601
University of Rochester Cancer Center
Rochester, New York, United States, 14642
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, United States, 10461
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Northeast Medical Center
Concord, North Carolina, United States, 28025
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27858-4354
Catawba Memorial Hospital
Hickory, North Carolina, United States, 28601
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, North Dakota
Meritcare Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44302
Akron City Hospital
Akron, Ohio, United States, 44309
Christ Hospital
Cincinnati, Ohio, United States, 45219
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
CCOP - Columbus
Columbus, Ohio, United States, 43206
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
CCOP - Dayton
Kettering, Ohio, United States, 45429
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States, 43623-3456
United States, Oklahoma
St. Anthony Hospital
Oklahoma City, Oklahoma, United States, 73101
St. John Health System
Tulsa, Oklahoma, United States, 74104
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97213
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
St. Luke's Hospital Regional Cancer Center
Bethlehem, Pennsylvania, United States, 18015
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Mercy Catholic Medical Center, Mercy Fitzgerald Divison
Darby, Pennsylvania, United States, 19023
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Penn State Geisinger Cancer Center
Hershey, Pennsylvania, United States, 17033
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102-1192
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213-3489
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States, 18501
Wilkes Barre General Hospital
Wilkes-Barre, Pennsylvania, United States, 18764
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
York Hospital
York, Pennsylvania, United States, 17315
United States, Rhode Island
Roger Williams Medical Center/BUSM
Providence, Rhode Island, United States, 02908-4735
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
United States, Tennessee
Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States, 38103
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
Harrington Cancer Center
Amarillo, Texas, United States, 79106
Julie and Ben Rogers Cancer Institute
Beaumont, Texas, United States, 77701
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, United States, 78236-5300
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
Bayshore Medical Center
Pasadena, Texas, United States, 77504
East Texas Medical Center - Cancer Institute
Tyler, Texas, United States, 75701
United States, Utah
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Vermont
CCOP - Southwestern Vermont Regional Cancer Center
Bennington, Vermont, United States, 05201
Vermont Cancer Center
Burlington, Vermont, United States, 05401-3498
Green Mountain Oncology Group
Rutland, Vermont, United States, 05701
United States, Virginia
Martha Jefferson Hospital
Charlottesville, Virginia, United States, 22901
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
RMH Regional Canter Center
Harrisonburg, Virginia, United States, 22801
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98111
Deaconess Medical Center
Spokane, Washington, United States, 99210-0248
Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, West Virginia
Schiffler Cancer Center
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-3508
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, United States, 54601
Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, United States, 53713
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States, 53051
St. Joseph's Hospital
Milwaukee, Wisconsin, United States, 53210
Columbia Hospital
Milwaukee, Wisconsin, United States, 53211
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States, 53295
Southeastern Wisconsin Regional Cancer Center
Racine, Wisconsin, United States, 53405
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Kingston Regional Cancer Centre
Kingston, Ontario, Canada, K7L 5P9
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Ottawa Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 1C4
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, Canada, P3E 5J1
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada, P7A 7T1
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
McGill University
Montreal, Quebec, Canada, H2W 1S6
Canada, Saskatchewan
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: David G. McGowan, MD Cross Cancer Institute at University of Alberta
  More Information

Publications:
McGowan D, Hunt D, Jones C, et al.: Effect of short-term endocrine therapy prior to and during radiation therapy on overall survival in patients with T1b-T2b adenocarcinoma of the prostate and PSA equal to or less than 20: initial results of RTOG 94-08. [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-6, 2010.
Bruner D, Scott C, McGowan D, et al.: Factors influencing sexual outcomes in prostate cancer patients enrolled on radiation therapy oncology group studies 90-20 and 94-08. [Abstract] Proceedings of the International Society for Quality of Life Research 7: 575, 1998.
Bruner DW, Scott CB, McGowan D, et al.: Validation of the sexual adjustment questionnaire (SAQ) in prostate cancer patients enrolled on Radiation Therapy Oncology Group studies 90-20 and 94-08. [Abstract] Int J Radiat Oncol Biol Phys 42 (suppl 1): A-156, 202, 1998.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00002597     History of Changes
Other Study ID Numbers: RTOG-9408
CDR0000063821
Study First Received: November 1, 1999
Results First Received: May 8, 2017
Last Updated: May 8, 2017

Keywords provided by Radiation Therapy Oncology Group:
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Goserelin
Flutamide
Leuprolide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on June 22, 2017