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Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00005044
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Results First Posted : October 31, 2017
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Casodex Drug: Eulexin Drug: LHRH agonist Radiation: radiation therapy Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1579 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Trial to Evaluate the Duration of Neoadjuvant Total Androgen Suppression (TAS) and Radiation Therapy (RT) in Intermediate-Risk Prostate Cancer
Actual Study Start Date : February 2000
Actual Primary Completion Date : September 2012

Resource links provided by the National Library of Medicine


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 Name: 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 Name: flutamide

Drug: LHRH agonist
LHRH agonist of choice. The manufacturer's instructions should be followed.
Other Names:
  • Zoladex
  • Lupron
  • 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 Name: 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 Name: flutamide

Drug: LHRH agonist
LHRH agonist of choice. The manufacturer's instructions should be followed.
Other Names:
  • Zoladex
  • Lupron
  • 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]




Primary Outcome Measures :
  1. Disease-specific Survival (DSS) (10-year Rates Reported) [ Time Frame: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) ]
    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.


Secondary Outcome Measures :
  1. Overall Survival (OS) (10-year Rates Reported) [ Time Frame: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) ]
    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.

  2. Disease-free Survival (DFS) (10-year Rates Reported) [ Time Frame: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) ]
    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.

  3. Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported) [ Time Frame: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) ]
    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.

  4. Time to First Biochemical Failure (BF) (10-year Rates Reported) [ Time Frame: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) ]

    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.


  5. Time to Second Biochemical Failure (SBF) (10-year Rates Reported) [ Time Frame: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) ]
    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.

  6. Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient) [ Time Frame: From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) ]
    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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005044


Locations
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United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
Comprehensive Cancer Institute
Huntsville, Alabama, United States, 35801
Huntsville Hospital
Huntsville, Alabama, United States, 35807
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36607
Montgomery Cancer Center
Montgomery, Alabama, United States, 36106-3657
DCH Cancer Treatment Center
Tuscaloosa, Alabama, United States, 35401
United States, Arizona
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
United States, California
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Mount Diablo Medical Center
Concord, California, United States, 94524-4110
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
California Cancer Center
Fresno, California, United States, 93720
Saint Agnes Cancer Center
Fresno, California, United States, 93720
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States, 94904
Loma Linda University Cancer Institute at 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, 90095-1714
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
Huntington Cancer Center at Huntington Hospital
Pasadena, California, United States, 91105
Robert and Beverly Lewis Family Cancer Care Center
Pomona, California, United States, 91767
Radiation Oncology Center - Sacramento
Sacramento, California, United States, 95816
Radiation Medical Group, Incorporated
San Diego, California, United States, 92101
Naval Medical Center - San Diego
San Diego, California, United States, 92134-3202
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
O'Connor Hospital
San Jose, California, United States, 95128
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
Torrance Memorial Medical Center
Torrance, California, United States, 90505
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
United States, Colorado
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States, 80909
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States, 80010
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502-1628
United States, Connecticut
Hospital of St. Raphael
New Haven, Connecticut, United States, 06511
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8040
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Florida
21st Century Oncology - Fort Myers
Fort Myers, Florida, United States, 33901-8082
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, United States, 32610-0385
Florida Radiation Oncology Group
Jacksonville, Florida, United States, 32207
Holmes Regional Medical Center
Melbourne, Florida, United States, 32901-3276
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
University of Miami Sylvester Cancer Center
Miami, Florida, United States, 33136
Baptist Hospital of Miami
Miami, Florida, United States, 33256-2110
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806-2134
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 Hospital
Tallahassee, Florida, United States, 32308
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
Winship Cancer Institute of Emory University
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, 31901
Regional Radiation Oncology Center at Rome
Rome, Georgia, United States, 30165
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
CCOP - Scott and White Hospital
Peoria, Illinois, United States, 61602
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
United States, Indiana
St. John's Medical Center
Anderson, Indiana, United States, 46016
Bloomington Hospital
Bloomington, Indiana, United States, 47402
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States, 46206-1367
Community Regional Cancer Care
Indianapolis, Indiana, United States, 46219
Ball Memorial Hospital Cancer Center
Muncie, Indiana, United States, 47303-3499
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, United States, 52001
United States, Kentucky
St. Elizabeth Medical Center
Edgewood, Kentucky, United States, 41017
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0293
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
Louisville Radiation Oncology Center at Caritas Regional Cancer Center
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
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112-2699
MBCCOP - LSU Health Sciences Center
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
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States, 21204
Harbor Hospital Center
Baltimore, Maryland, United States, 21215-1290
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
St. Agnes Cancer Center
Baltimore, Maryland, United States, 21229
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02114
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States, 02130
NSMC Cancer Center
Peabody, Massachusetts, United States, 01960
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0010
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Hurley Medical Center
Flint, Michigan, United States, 48503
McLaren Regional Cancer Center
Flint, Michigan, United States, 48532-3685
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
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital - Troy
Troy, Michigan, United States, 48085
United States, Minnesota
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905-0001
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
St. Louis University Hospital Cancer 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
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114-4199
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7521
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89109
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth Medical School
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, 01803
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07019
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 Virtua Health Cancer Program at Virtua Memorial Hospital
Mount Holly, New Jersey, United States, 08060
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Atlantic City Medical Center
Pomona, New Jersey, United States, 08240
Medical Center of Princeton
Princeton, New Jersey, United States, 08540
Valley Hospital
Ridgewood, New Jersey, United States, 07450
Somerset Medical Center
Somerville, New Jersey, United States, 08876
Community Medical Center
Toms River, New Jersey, United States, 08755
Fox Chase Cancer Center at St. Francis Medical Center
Trenton, New Jersey, United States, 08629
Associated Radiologists, P.A.
Warren, New Jersey, United States, 07059
United States, New Mexico
Radiation Oncology Associates of Albuquerque
Albuquerque, New Mexico, United States, 87109
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
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Finger Lakes Radiation Oncology Center
Clifton Springs, New York, United States, 14432
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Beth Israel Medical Center - Philipps Ambulatory Care Center
New York, New York, United States, 10003
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States, 12901-1490
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
Riverhill Radiation Oncology
Yonkers, New York, United States, 10701
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Batte Cancer Center at Northeast Medical Center
Concord, North Carolina, United States, 28025
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
Greenville, North Carolina, United States, 27835-6028
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
Trinity Cancer Care Center
Minot, North Dakota, United States, 58701
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44302
Akron City Hospital
Akron, Ohio, United States, 44304
Cancer Center at Christ Hospital
Cincinnati, Ohio, United States, 45219
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45219
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
CCOP - Columbus
Columbus, Ohio, United States, 43206
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
CCOP - Dayton
Dayton, Ohio, United States, 45429
Parma Community General Hospital
Parma, Ohio, United States, 44129
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
United States, Oklahoma
Frank C. Love Cancer Institute at St. Anthony Hospital
Oklahoma City, Oklahoma, United States, 73102
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
St. John Health System
Tulsa, Oklahoma, United States, 74104
CCOP - Oklahoma
Tulsa, Oklahoma, United States, 74136
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States, 18015
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States, 19023
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Pocono Cancer Center
East Stroudsburg, Pennsylvania, United States, 18301
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104-4283
Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Kimmel Cancer Center at 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, 19141-3098
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15236
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, 18764-0001
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Wellspan Health - York Cancer Center
York, Pennsylvania, United States, 17403
United States, Rhode Island
Roger Williams Medical Center
Providence, Rhode Island, United States, 02908-4735
United States, South Carolina
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
West Tennessee Cancer Center at Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-5671
United States, Texas
Harrington Cancer Center
Amarillo, Texas, United States, 79106
Arlington Cancer Center
Arlington, Texas, United States, 76012
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 Medical Center
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
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
United States, Utah
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
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
Green Mountain Oncology Group
Bennington, Vermont, United States, 05201
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05405-0075
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
RMH Regional Cancer Center
Harrisonburg, Virginia, United States, 22801
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Bon Secours - St. Mary's Hospital
Richmond, Virginia, United States, 23226
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0058
United States, Washington
Cancer Institute at Virginia Mason Medical Center
Seattle, Washington, United States, 98111
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Deaconess Medical Center
Spokane, Washington, United States, 99204
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
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-3508
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
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
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States, 53051
Columbia Hospital
Milwaukee, Wisconsin, United States, 53211
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States, 53295
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, United States, 53405
Waukesha Memorial Hospital Regional Cancer Center
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, New Brunswick
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
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
Margaret and Charles Juravinski 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
Ottawa, Ontario, Canada, K1H 1C4
Northeastern Ontario Regional Cancer Centre - Sudbury
Sudbury, Ontario, Canada, P3E 5J1
Northwestern Ontario Regional Cancer Care
Thunder Bay, Ontario, Canada, P7B 6V4
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
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L 4MI
McGill University
Montreal, Quebec, Canada, H2W 1S6
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Study Chair: Michael G. Haddock, MD Mayo Clinic

Publications of Results:
Layout table for additonal information
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00005044    
Other Study ID Numbers: RTOG-9910
CDR0000067635
First Posted: January 27, 2003    Key Record Dates
Results First Posted: October 31, 2017
Last Update Posted: June 11, 2019
Last Verified: May 2019
Keywords provided by Radiation Therapy Oncology Group:
adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Bicalutamide
Flutamide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents
Antineoplastic Agents, Hormonal