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
2 other identifiers
interventional
1,579
2 countries
261
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Feb 2000
Longer than P75 for phase_3 prostate-cancer
261 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2000
CompletedFirst Submitted
Initial submission to the registry
April 6, 2000
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedResults Posted
Study results publicly available
October 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2022
CompletedJune 15, 2022
May 1, 2022
12.6 years
April 6, 2000
October 2, 2017
May 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Overall Survival (OS) (10-year Rates 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)
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)
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)
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)
From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
- +1 more secondary outcomes
Study Arms (2)
TAS x 8 weeks
EXPERIMENTALTotal 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).
TAS x 28 weeks
EXPERIMENTALTAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
Interventions
Orally at a dose of one 50 mg tablet per day started within (before or after) 14 days of the first LHRH agonist injection.
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.
LHRH agonist of choice. The manufacturer's instructions should be followed.
\[Prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin receives 70.2 Gy (1.8 Gy/day x 39 fractions, five days/week)\] OR \[regional nodes, prostate and seminal vesicles + 1.0-1.5 cm margin will receive 46.8 Gy (1.8 Gy/day x 26 fractions, five days/week), followed by a 23.4 Gy (1.8 Gy/day x 13 fractions, five days/week) boost to the prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin\]
Eligibility Criteria
You may qualify if:
- Adenocarcinoma of prostatic origin histologically-confirmed within 180 days of the randomization date.
- Zubrod Performance Status 0-1 (Appendix II).
- Prostatic biopsy tumor grading by the Gleason Score classification (Appendix VI) is mandatory prior to randomization.
- 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.
- 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.
- 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.
- Pretherapy serum (total) prostate-specific antigen value performed with a Federal Drug Administration approved assay method, e.g. Abbott, Hybritech, etc.
- Treatment must begin within 6 weeks after randomization.
- Alanine aminotransferase (ALT) must be within 2 x upper normal limit.
- Patients must sign a study-specific informed consent form (Appendix I) prior to randomization.
You may not qualify if:
- 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).
- Patients at low risk for disease relapse as determined by:
- Clinical stage ≤T2, Gleason score ≤ 6, and prostate-specific antigen ≤ 10.
- Clinical stage Tx, T0, or T1a.
- Histologic or radiologic evidence of tumor involvement of regional lymph nodes (N1) or the presence of metastatic disease (M1).
- Pretherapy serum prostate-specific antigen level \> 100.
- Co-morbid medical illness which in the opinion of the investigator is expected to result in a life expectancy of \<10 years.
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radiation Therapy Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (261)
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300, United States
Comprehensive Cancer Institute
Huntsville, Alabama, 35801, United States
Huntsville Hospital
Huntsville, Alabama, 35807, United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36607, United States
Montgomery Cancer Center
Montgomery, Alabama, 36106-3657, United States
DCH Cancer Treatment Center
Tuscaloosa, Alabama, 35401, United States
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013, United States
Providence Saint Joseph Medical Center - Burbank
Burbank, California, 91505, United States
Mount Diablo Medical Center
Concord, California, 94524-4110, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000, United States
California Cancer Center
Fresno, California, 93720, United States
Saint Agnes Cancer Center
Fresno, California, 93720, United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, 94904, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, 90822, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1714, United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305, United States
Huntington Cancer Center at Huntington Hospital
Pasadena, California, 91105, United States
Robert and Beverly Lewis Family Cancer Care Center
Pomona, California, 91767, United States
Radiation Oncology Center - Sacramento
Sacramento, California, 95816, United States
Radiation Medical Group, Incorporated
San Diego, California, 92101, United States
Naval Medical Center - San Diego
San Diego, California, 92134-3202, United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94115, United States
O'Connor Hospital
San Jose, California, 95128, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403, United States
Torrance Memorial Medical Center
Torrance, California, 90505, United States
David Grant Medical Center
Travis Air Force Base, California, 94535, United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, 80909, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80010, United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, 80224, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, 81502-1628, United States
Hospital of St. Raphael
New Haven, Connecticut, 06511, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8040, United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
21st Century Oncology - Fort Myers
Fort Myers, Florida, 33901-8082, United States
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, 32610-0385, United States
Florida Radiation Oncology Group
Jacksonville, Florida, 32207, United States
Holmes Regional Medical Center
Melbourne, Florida, 32901-3276, United States
University of Miami Sylvester Cancer Center
Miami, Florida, 33136, United States
Baptist Hospital of Miami
Miami, Florida, 33256-2110, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, 32806-2134, United States
Bay Medical Center
Panama City, Florida, 32401, United States
Gulf Coast Cancer Treatment Center
Panama City, Florida, 32405-4587, United States
Sarasota Radiation and Medical Oncology Center
Sarasota, Florida, 34233, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701, United States
Medical Center/John B. Amos Community Cancer Center
Columbus, Georgia, 31901, United States
Regional Radiation Oncology Center at Rome
Rome, Georgia, 30165, United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813, United States
Northwest Community Hospital
Arlington Heights, Illinois, 60005, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013, United States
CCOP - Central Illinois
Decatur, Illinois, 62526, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, 60153, United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068, United States
CCOP - Scott and White Hospital
Peoria, Illinois, 61602, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
St. John's Medical Center
Anderson, Indiana, 46016, United States
Bloomington Hospital
Bloomington, Indiana, 47402, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202, United States
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, 46206-1367, United States
Community Regional Cancer Care
Indianapolis, Indiana, 46219, United States
Ball Memorial Hospital Cancer Center
Muncie, Indiana, 47303-3499, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, 52001, United States
St. Elizabeth Medical Center
Edgewood, Kentucky, 41017, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536-0293, United States
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
Louisville Radiation Oncology Center at Caritas Regional Cancer Center
Louisville, Kentucky, 40215, United States
Merle M. Mahr Cancer Center
Madisonville, Kentucky, 42431, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112-2699, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112, United States
CCOP - Ochsner
New Orleans, Louisiana, 70121, United States
Maine Medical Center
Portland, Maine, 04102, United States
Anne Arundel Oncology Center
Annapolis, Maryland, 21401, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201, United States
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, 21204, United States
Harbor Hospital Center
Baltimore, Maryland, 21215-1290, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
St. Agnes Cancer Center
Baltimore, Maryland, 21229, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410, United States
Peninsula Regional Medical Center
Salisbury, Maryland, 21801, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02114, United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, 02118, United States
Cape Cod Hospital
Hyannis, Massachusetts, 02601, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130, United States
NSMC Cancer Center
Peabody, Massachusetts, 01960, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0010, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
McLaren Regional Cancer Center
Flint, Michigan, 48532-3685, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731, United States
Marquette General Hospital
Marquette, Michigan, 49855, United States
MidMichigan Medical Center - Midland
Midland, Michigan, 48670, United States
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769, United States
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073, United States
William Beaumont Hospital - Troy
Troy, Michigan, 48085, United States
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, 55455, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905-0001, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203, United States
CCOP - Kansas City
Kansas City, Missouri, 64131, United States
Cancer Research for the Ozarks
Springfield, Missouri, 65807, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807, United States
St. Louis University Hospital Cancer Center
St Louis, Missouri, 63110-0250, United States
Mallinckrodt Institute of Radiology
St Louis, Missouri, 63110, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, 68114-4199, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, 68198-7521, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89109, United States
Norris Cotton Cancer Center at Dartmouth Medical School
Lebanon, New Hampshire, 03756-0002, United States
Elliot Regional Cancer Center
Manchester, New Hampshire, 03103, United States
Cooper Cancer Institute
Camden, New Jersey, 01803, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07019, United States
John F. Kennedy Medical Center
Edison, New Jersey, 08818, United States
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, 07201, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740-6395, United States
South Jersey Regional Cancer Center
Millville, New Jersey, 08332, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Mount Holly, New Jersey, 08060, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Atlantic City Medical Center
Pomona, New Jersey, 08240, United States
Medical Center of Princeton
Princeton, New Jersey, 08540, United States
Valley Hospital
Ridgewood, New Jersey, 07450, United States
Somerset Medical Center
Somerville, New Jersey, 08876, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
Fox Chase Cancer Center at St. Francis Medical Center
Trenton, New Jersey, 08629, United States
Associated Radiologists, P.A.
Warren Township, New Jersey, 07059, United States
Radiation Oncology Associates of Albuquerque
Albuquerque, New Mexico, 87109, United States
Cancer Center of Albany Medical Center
Albany, New York, 12208, United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001, United States
Finger Lakes Radiation Oncology Center
Clifton Springs, New York, 14432, United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030, United States
Beth Israel Medical Center - Philipps Ambulatory Care Center
New York, New York, 10003, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, 10032, United States
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, 12901-1490, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217, United States
Riverhill Radiation Oncology
Yonkers, New York, 10701, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295, United States
Batte Cancer Center at Northeast Medical Center
Concord, North Carolina, 28025, United States
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
Greenville, North Carolina, 27835-6028, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082, United States
Trinity Cancer Care Center
Minot, North Dakota, 58701, United States
Akron General Medical Center
Akron, Ohio, 44302, United States
Akron City Hospital
Akron, Ohio, 44304, United States
Cancer Center at Christ Hospital
Cincinnati, Ohio, 45219, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45219, United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
CCOP - Columbus
Columbus, Ohio, 43206, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240, United States
CCOP - Dayton
Dayton, Ohio, 45429, United States
Parma Community General Hospital
Parma, Ohio, 44129, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456, United States
Frank C. Love Cancer Institute at St. Anthony Hospital
Oklahoma City, Oklahoma, 73102, United States
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
St. John Health System
Tulsa, Oklahoma, 74104, United States
CCOP - Oklahoma
Tulsa, Oklahoma, 74136, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, 18105, United States
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, 18015, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001, United States
Mercy Fitzgerald Hospital
Darby, Pennsylvania, 19023, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026, United States
Pocono Cancer Center
East Stroudsburg, Pennsylvania, 18301, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104-4283, United States
Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141-3098, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15219, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15236, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052, United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, 18501, United States
Wilkes-Barre General Hospital
Wilkes-Barre, Pennsylvania, 18764-0001, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096, United States
Wellspan Health - York Cancer Center
York, Pennsylvania, 17403, United States
Roger Williams Medical Center
Providence, Rhode Island, 02908-4735, United States
CCOP - Greenville
Greenville, South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709, United States
West Tennessee Cancer Center at Jackson-Madison County General Hospital
Jackson, Tennessee, 38301, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, 37232-5671, United States
Harrington Cancer Center
Amarillo, Texas, 79106, United States
Arlington Cancer Center
Arlington, Texas, 76012, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0209, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236-5300, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894, United States
Bayshore Medical Center
Pasadena, Texas, 77504, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Dixie Regional Medical Center
St. George, Utah, 84770, United States
Green Mountain Oncology Group
Bennington, Vermont, 05201, United States
Vermont Cancer Center at University of Vermont
Burlington, Vermont, 05405-0075, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908, United States
RMH Regional Cancer Center
Harrisonburg, Virginia, 22801, United States
Naval Medical Center, Portsmouth
Portsmouth, Virginia, 23708-2197, United States
Bon Secours - St. Mary's Hospital
Richmond, Virginia, 23226, United States
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, 23298-0058, United States
Cancer Institute at Virginia Mason Medical Center
Seattle, Washington, 98111, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195-6043, United States
Deaconess Medical Center
Spokane, Washington, 99204, United States
Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301, United States
St. Vincent Hospital
Green Bay, Wisconsin, 54307-3508, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, 53713, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Community Memorial Hospital
Menomonee Falls, Wisconsin, 53051, United States
Columbia Hospital
Milwaukee, Wisconsin, 53211, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295, United States
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, 53405, United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, 53188, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3, Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Northeastern Ontario Regional Cancer Centre - Sudbury
Greater Sudbury, Ontario, P3E 5J1, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4, Canada
Northwestern Ontario Regional Cancer Care
Thunder Bay, Ontario, P7B 6V4, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L 4MI, Canada
McGill University
Montreal, Quebec, H2W 1S6, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, G1R 2J6, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Related Publications (2)
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.
PMID: 25534388RESULTSpratt DE, Tang S, Sun Y, Huang HC, Chen E, Mohamad O, Armstrong AJ, Tward JD, Nguyen PL, Lang JM, Zhang J, Mitani A, Simko JP, DeVries S, van der Wal D, Pinckaers H, Monson JM, Campbell HA, Wallace J, Ferguson MJ, Bahary JP, Schaeffer EM, Sandler HM, Tran PT, Rodgers JP, Esteva A, Yamashita R, Feng FY. Artificial Intelligence Predictive Model for Hormone Therapy Use in Prostate Cancer. NEJM Evid. 2023 Aug;2(8):EVIDoa2300023. doi: 10.1056/EVIDoa2300023. Epub 2023 Jun 29.
PMID: 38320143DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The data monitoring committee decided in June 2012 after the first interim analysis that the trial should be reported early due to the low number of events.
Results Point of Contact
- Title
- Wendy Seiferheld, M.S.
- Organization
- NRG Oncology
Study Officials
- STUDY CHAIR
Michael G. Haddock, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2000
First Posted
January 27, 2003
Study Start
February 1, 2000
Primary Completion
September 1, 2012
Study Completion
May 20, 2022
Last Updated
June 15, 2022
Results First Posted
October 31, 2017
Record last verified: 2022-05