Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
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
2 other identifiers
interventional
2,028
2 countries
239
Brief Summary
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.
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 Oct 1994
Longer than P75 for phase_3 prostate-cancer
239 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
October 1, 1994
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
February 27, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedResults Posted
Study results publicly available
June 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2018
CompletedJune 14, 2018
May 1, 2018
16.8 years
November 1, 1999
May 8, 2017
May 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival Rate (10-year)
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.
From date of randomization to 10 years
Secondary Outcomes (8)
Disease-specific Survival Rate (10 Years)
From registration to 10 years
Local Progression Rate (10 Years)
From registration to 10 years
Distant Failure Rate (10 Years)
From registration to 10 years
Biochemical Failure Rate (10 Years)
From registration to 10 years
Clinical Relapse Rate (10 Years)
From registration to 10 years
- +3 more secondary outcomes
Study Arms (2)
Neoadjuvant TAS + RT
EXPERIMENTALNeoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
Radiation therapy alone
OTHERRadiation therapy alone
Interventions
Two 125 mg capsules (t.i.d., p.o.) beginning two months before RT and continuing until RT is completed.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radiation Therapy Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (239)
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300, United States
Huntsville Hospital System
Huntsville, Alabama, 35801-4470, United States
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, 35801, United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688, United States
Alabama Oncology, LLC
Montgomery, Alabama, 36106-2801, United States
Radiation Oncology Associates of West Alabama
Tuscaloosa, Alabama, 35401, United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Mount Diablo Medical Center
Concord, California, 94524-4110, United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000, United States
California Cancer Center
Fresno, California, 93720, United States
Saint Agnes Cancer Center
Fresno, California, 93720, United States
Glendale Memorial Hospital and Health Center
Glendale, California, 91204, United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, 94904, United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658, United States
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, 90095-1781, United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305, United States
Cancer Care Center
Pomona, California, 91767, United States
Radiation Oncology Center - Sacramento
Sacramento, California, 95816, United States
Radiation Medical Group, Inc.
San Diego, California, 92101-1492, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128, United States
O'Connor Hospital
San Jose, California, 95128, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403, United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, 80909, United States
University of Colorado Cancer Center
Denver, Colorado, 80010, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000, United States
Lykes Center for Radiation Therapy
Clearwater, Florida, 33757-0210, United States
Halifax Medical Center
Daytona Beach, Florida, 32114, United States
Radiation Therapy Associates - Fort Myers
Fort Myers, Florida, 33901, United States
University of Florida Health Science Center
Gainesville, Florida, 32610-0296, United States
Health First Holmes Regional Medical Center
Melbourne, Florida, 32901, United States
dVeterans Affairs Medical Center - Miami
Miami, Florida, 33125, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136, United States
Baptist Hospital of Miami
Miami, Florida, 33176-2197, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Florida Radiation Oncology Group
Orange Park, Florida, 32073, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, 32806, 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 Healthcare
Tallahassee, Florida, 32308, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322, United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701, United States
Medical Center/John B. Amos Community Cancer Center
Columbus, Georgia, 31902, United States
InterCommunity Cancer Center at Rome
Rome, Georgia, 30161, United States
Northwest Community Hospital
Arlington Heights, Illinois, 60005, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470, United States
CCOP - Central Illinois
Decatur, Illinois, 62526, United States
Provena St. Joseph Hospital- Regional Cancer Care Center
Elgin, Illinois, 60123, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
St. John's Medical Center
Anderson, Indiana, 46016, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202, United States
Clarion Health Partners Inc.
Indianapolis, Indiana, 46206-1367, United States
Community Hospitals of Indianapolis - Regional Cancer Center
Indianapolis, Indiana, 46219, United States
Ball Memorial Hospital
Muncie, Indiana, 47303-3499, United States
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, 52001, United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40511-1093, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084, United States
James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
Louisville Radiation Oncology
Louisville, Kentucky, 40215, United States
Merle M. Mahr Cancer Center
Madisonville, Kentucky, 42431, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Romagosa Radiation Oncology Center
Lafayette, Louisiana, 70501, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112, United States
Tulane University School of Medicine
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
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, 21204, United States
Harbor Hospital Center
Baltimore, Maryland, 21225, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21225, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231-2410, United States
Radiation Oncology Affiliates of Maryland, P.A.
Baltimore, Maryland, 21237, United States
Peninsula Regional Medical Center
Salisbury, Maryland, 21801, United States
Cape Cod Hospital
Hyannis, Massachusetts, 02601, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
McLaren Regional Cancer Center
Flint, Michigan, 48432, United States
Hurley Medical Center
Flint, Michigan, 48503, 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
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
St. Mary's Medical Center
Saginaw, Michigan, 48601, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
North Mississippi Medical Center/Cancer Center
Tupelo, Mississippi, 38801, United States
Ellis Fischel Cancer Center - 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 Health Sciences 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
Nebraska Health System
Omaha, Nebraska, 68105-1018, United States
Methodist Cancer Center - Omaha
Omaha, Nebraska, 68114, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002, United States
Elliot Regional Cancer Center
Manchester, New Hampshire, 03103, United States
Cooper Cancer Institute
Camden, New Jersey, 08103, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095, 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 Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Atlantic City Medical Center
Pomona, New Jersey, 08240, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
Capital Health System at Mercer
Trenton, New Jersey, 08607, United States
St. Francis Medical Center
Trenton, New Jersey, 08629, United States
Associated Radiologists, P.A.
Warren Township, New Jersey, 07059, United States
Saint Joseph Medical Center
Albuquerque, New Mexico, 87102, 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, 11215-3609, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001, United States
Finger Lakes Radiation Oncology, P.C.
Clifton Springs, New York, 14432, United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, 12901, United States
Vassar Brothers Hospital
Poughkeepsie, New York, 12601, United States
University of Rochester Cancer Center
Rochester, New York, 14642, United States
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, 10461, United States
New York Medical College
Valhalla, New York, 10595, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295, United States
Northeast Medical Center
Concord, North Carolina, 28025, United States
East Carolina University School of Medicine
Greenville, North Carolina, 27858-4354, United States
Catawba Memorial Hospital
Hickory, North Carolina, 28601, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082, United States
Meritcare Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Akron General Medical Center
Akron, Ohio, 44302, United States
Akron City Hospital
Akron, Ohio, 44309, United States
Christ Hospital
Cincinnati, Ohio, 45219, United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, 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
Kettering, Ohio, 45429, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456, United States
St. Anthony Hospital
Oklahoma City, Oklahoma, 73101, United States
St. John Health System
Tulsa, Oklahoma, 74104, United States
CCOP - Columbia River Program
Portland, Oregon, 97213, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
St. Luke's Hospital Regional Cancer Center
Bethlehem, Pennsylvania, 18015, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001, United States
Mercy Catholic Medical Center, Mercy Fitzgerald Divison
Darby, Pennsylvania, 19023, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026, United States
Penn State Geisinger Cancer Center
Hershey, Pennsylvania, 17033, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283, United States
Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Kimmel Cancer Center of 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, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489, United States
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15219, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, 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, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096, United States
York Hospital
York, Pennsylvania, 17315, United States
Roger Williams Medical Center/BUSM
Providence, Rhode Island, 02908-4735, United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721, 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
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301, United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838, United States
Harrington Cancer Center
Amarillo, Texas, 79106, United States
Julie and Ben Rogers Cancer Institute
Beaumont, Texas, 77701, 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 - 59th Medical Wing
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
East Texas Medical Center - Cancer Institute
Tyler, Texas, 75701, 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
CCOP - Southwestern Vermont Regional Cancer Center
Bennington, Vermont, 05201, United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498, United States
Green Mountain Oncology Group
Rutland, Vermont, 05701, United States
Martha Jefferson Hospital
Charlottesville, Virginia, 22901, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908, United States
RMH Regional Canter Center
Harrisonburg, Virginia, 22801, United States
Virginia Mason Medical Center
Seattle, Washington, 98111, United States
Deaconess Medical Center
Spokane, Washington, 99210-0248, United States
Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
St. Vincent Hospital
Green Bay, Wisconsin, 54307-3508, United States
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, 54601, United States
Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, 53713, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Community Memorial Hospital
Menomonee Falls, Wisconsin, 53051, United States
St. Joseph's Hospital
Milwaukee, Wisconsin, 53210, United States
Columbia Hospital
Milwaukee, Wisconsin, 53211, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295, United States
Southeastern Wisconsin Regional Cancer Center
Racine, Wisconsin, 53405, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6, 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
Cancer Care Ontario-Hamilton Regional 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 - General Campus
Ottawa, Ontario, K1H 1C4, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1, 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
McGill University
Montreal, Quebec, H2W 1S6, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Related Publications (7)
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.
BACKGROUNDBruner 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.
BACKGROUNDJohnke RM, Edwards JM, Evans MJ, Nangami GN, Bakken NT, Kilburn JM, Lee TK, Allison RR, Karlsson UL, Arastu HH. Circulating cytokine levels in prostate cancer patients undergoing radiation therapy: influence of neoadjuvant total androgen suppression. In Vivo. 2009 Sep-Oct;23(5):827-33.
PMID: 19779119BACKGROUNDJones CU, Hunt D, McGowan DG, Amin MB, Chetner MP, Bruner DW, Leibenhaut MH, Husain SM, Rotman M, Souhami L, Sandler HM, Shipley WU. Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med. 2011 Jul 14;365(2):107-18. doi: 10.1056/NEJMoa1012348.
PMID: 21751904RESULTMcGowan 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.
RESULTSpratt 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: 38320143DERIVEDJones CU, Pugh SL, Sandler HM, Chetner MP, Amin MB, Bruner DW, Zietman AL, Den RB, Leibenhaut MH, Longo JM, Bahary JP, Rosenthal SA, Souhami L, Michalski JM, Hartford AC, Amin PP, Roach M 3rd, Yee D, Efstathiou JA, Rodgers JP, Feng FY, Shipley WU. Adding Short-Term Androgen Deprivation Therapy to Radiation Therapy in Men With Localized Prostate Cancer: Long-Term Update of the NRG/RTOG 9408 Randomized Clinical Trial. Int J Radiat Oncol Biol Phys. 2022 Feb 1;112(2):294-303. doi: 10.1016/j.ijrobp.2021.08.031. Epub 2021 Sep 1.
PMID: 34481017DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wendy Seiferheld, M.S.
- Organization
- NRG Oncology
Study Officials
- STUDY CHAIR
David G. McGowan, MD
Cross Cancer Institute at University of Alberta
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
November 1, 1999
First Posted
February 27, 2004
Study Start
October 1, 1994
Primary Completion
July 1, 2011
Study Completion
May 14, 2018
Last Updated
June 14, 2018
Results First Posted
June 6, 2017
Record last verified: 2018-05