Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer
NCT ID: NCT00288080
Last Updated: 2022-06-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
612 participants
INTERVENTIONAL
2005-12-31
2022-05-20
Brief Summary
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PURPOSE: This randomized phase III trial is studying hormone therapy and radiation therapy followed by docetaxel and prednisone to see how well it works compared to hormone therapy and radiation therapy in treating patients with localized prostate cancer.
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Detailed Description
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Primary
* Compare the relative efficacy, in terms of overall survival, of the combination of androgen suppression and radiotherapy versus androgen suppression and radiotherapy followed by docetaxel and prednisone in patients with localized, high-risk prostate cancer.
Secondary
* Compare the disease-free survival and incidence of adverse events in patients treated with these regimens.
* Compare the biochemical control, local control, and freedom from distant metastases in patients treated with these regimens.
* Determine the validity of prostate-specific antigen (PSA)-defined endpoints as a surrogate for overall survival of patients treated with these regimens.
* Compare the time interval between biochemical failure and distant metastases with respect to testosterone level in patients treated with these regimens.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to risk group.
* Arm I: Patients receive androgen suppression therapy comprising luteinizing hormone-releasing hormone (LHRH) agonist (e.g., leuprolide acetate, goserelin, buserelin, or triptorelin) and oral antiandrogen (i.e., oral flutamide 3 times daily for 2 months or oral bicalutamide once daily for 2 months). Beginning at week 8, patients undergo radiotherapy 5 days a week for approximately 8 weeks. Antiandrogen therapy is discontinued at completion of radiotherapy, but LHRH agonist therapy continues for 20 months.
* Arm II: Patients receive androgen suppression therapy and undergo radiotherapy as in arm I. Beginning 4 weeks after completion of radiotherapy, patients receive docetaxel IV over 1 hour on day 1 and oral prednisone daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients continue LHRH agonist therapy as in arm I.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Androgen suppression + Radiation Therapy
Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of radiation therapy (RT).
Oral antiandrogen
Oral antiandrogen of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy. Treatment is discontinued at the end of radiation therapy.
Radiation therapy
46.8 Gy, using either three-dimensional conformal radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT), will be given to the regional lymphatics followed by a 25.2-28.8 Gy boost to the prostate, to bring the total dose to the prostate to 72.0-75.6 Gy. Daily prescription doses will be 1.8 Gy per day, 5 days per week x 8-8.5 weeks, beginning 8 weeks after the initiation of androgen suppression.
LHRH agonist
LHRH agonist of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy, and then until 24 months from initiation of any treatment has been reached.
Androgen suppression + Radiation Therapy + Chemotherapy
Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
Dexamethasone
Premedication of dexamethasone prior to docetaxel, per institutional standards.
Prednisone
10 mg orally per day until day 21 of the last cycle of docetaxel, beginning 28 days after the completion of RT.
docetaxel
75 mg/m2 i.v. over 1 hour (on day 1 of each cycle) every 21 days for 6 cycles, beginning 28 days after the completion of RT.
Oral antiandrogen
Oral antiandrogen of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy. Treatment is discontinued at the end of radiation therapy.
Radiation therapy
46.8 Gy, using either three-dimensional conformal radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT), will be given to the regional lymphatics followed by a 25.2-28.8 Gy boost to the prostate, to bring the total dose to the prostate to 72.0-75.6 Gy. Daily prescription doses will be 1.8 Gy per day, 5 days per week x 8-8.5 weeks, beginning 8 weeks after the initiation of androgen suppression.
LHRH agonist
LHRH agonist of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy, and then until 24 months from initiation of any treatment has been reached.
Interventions
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Dexamethasone
Premedication of dexamethasone prior to docetaxel, per institutional standards.
Prednisone
10 mg orally per day until day 21 of the last cycle of docetaxel, beginning 28 days after the completion of RT.
docetaxel
75 mg/m2 i.v. over 1 hour (on day 1 of each cycle) every 21 days for 6 cycles, beginning 28 days after the completion of RT.
Oral antiandrogen
Oral antiandrogen of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy. Treatment is discontinued at the end of radiation therapy.
Radiation therapy
46.8 Gy, using either three-dimensional conformal radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT), will be given to the regional lymphatics followed by a 25.2-28.8 Gy boost to the prostate, to bring the total dose to the prostate to 72.0-75.6 Gy. Daily prescription doses will be 1.8 Gy per day, 5 days per week x 8-8.5 weeks, beginning 8 weeks after the initiation of androgen suppression.
LHRH agonist
LHRH agonist of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy, and then until 24 months from initiation of any treatment has been reached.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed prostate cancer at high-risk for recurrence within the past 180 days as determined by 1 of the following combinations (risk groups):
* Gleason score ≥ 9, prostate-specific antigen (PSA) ≤ 150 ng/mL, and any T stage
* Gleason score 8, PSA \< 20 ng/mL, and stage ≥ T2
* Gleason score 8, PSA 20-150 ng/mL, and any T stage
* Gleason score 7, PSA 20-150 ng/mL, and any T stage
* Clinically negative lymph nodes by imaging (pelvic CT scan or pelvic MRI), nodal sampling, or dissection within 90 days prior to study entry
* Equivocal or questionable lymph nodes ≤ 1.5 cm by imaging allowed
* Positive lymph nodes by capromab pendetide (ProstaScint\^®) scan with a corresponding lymph node ≤ 1.5 cm by CT scan or MRI allowed
* PSA ≤ 150 ng/mL
* Cannot have been obtained during any of the following time points:
* 10-day period after prostate biopsy
* After initiation of hormonal therapy
* Within 30 days after discontinuation of finasteride
* Within 90 days after discontinuation of dutasteride
* No distant metastases by physical exam and bone scan
* Equivocal bone scan findings allowed if plain films are negative
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-1
* Platelet count ≥ 100,000/mm\^3
* Absolute neutrophil count ≥ 1,800/mm\^3
* Hemoglobin ≥ 8 g/dL (transfusion or other intervention allowed)
* Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2.5 times ULN
* Bilirubin ≤ 1.5 times ULN
* Fertile patients must use effective contraception during and for at least 3 months after completion of study treatment
* No prior invasive malignancy, except nonmelanomatous skin cancer or other malignancy, unless disease-free for ≥ 3 years (e.g., carcinoma in situ of the oral cavity or bladder are allowed)
* No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
* No transmural myocardial infarction within the past 6 months
* No acute bacterial or fungal infection requiring intravenous antibiotics
* No AIDS
* No prior allergic reaction to any study drugs or other drugs formulated with polysorbate 80
* No existing peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
* At least 60 days since prior 5-alpha reductase inhibitor (e.g., finasteride) for prostatic hypertrophy
* At least 90 days since prior testosterone
* Prior pharmacologic androgen ablation for prostate cancer allowed provided androgen ablation was initiated no more than 50 days prior to study entry
* No prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy
* No prior systemic chemotherapy for prostate cancer
* Prior chemotherapy for a different cancer is allowed
* No prior radiotherapy, including brachytherapy, to the region of prostate cancer that would result in overlap of radiotherapy fields
* Intensity modulated radiotherapy allowed
18 Years
120 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Howard M. Sandler, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center
Seth Rosenthal, MD
Role: STUDY_CHAIR
Radiological Associates of Sacramento Medical Group at Sutter Cancer Center
Mahul Amin, MD
Role: STUDY_CHAIR
Cedars-Sinai Medical Center
Leonard G. Gomella, MD
Role: STUDY_CHAIR
Sidney Kimmel Cancer Center at Thomas Jefferson University
James Purdy, PhD
Role: STUDY_CHAIR
University of California, Davis
Jeff Michalski, MD
Role: STUDY_CHAIR
Washington University School of Medicine
Mark Garzotto, MD
Role: STUDY_CHAIR
Portland VA Medical Center
Oliver Sartor, MD
Role: STUDY_CHAIR
Tulane School of Medicine
Locations
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UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
Providence Cancer Center
Anchorage, Alaska, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, United States
Arizona Oncology - Tucson
Tucson, Arizona, United States
Auburn Radiation Oncology
Auburn, California, United States
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States
Enloe Cancer Center at Enloe Medical Center
Chico, California, United States
Cancer Care Center at John Muir Health - Concord Campus
Concord, California, United States
Washington Township Hospital
Fremont, California, United States
Sierra Nevada Cancer Center at Sierra Nevada Memorial Hospital
Grass Valley, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Memorial Medical Center
Modesto, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center
Rancho Mirage, California, United States
Radiation Oncology Center - Roseville
Roseville, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Mercy General Hospital
Sacramento, California, United States
California Pacific Medical Center - California Campus
San Francisco, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
Solano Radiation Oncology Center
Vacaville, California, United States
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, United States
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Poudre Valley Radiation Oncology
Fort Collins, Colorado, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States
North Colorado Medical Center
Greeley, Colorado, United States
McKee Medical Center
Loveland, Colorado, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States
St. Vincent's Medical Center
Bridgeport, Connecticut, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Hospital of Saint Raphael
New Haven, Connecticut, United States
Yale Cancer Center
New Haven, Connecticut, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
William W. Backus Hospital
Norwich, Connecticut, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Bay Medical
Panama City, Florida, United States
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta, Georgia, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
John B. Amos Cancer Center
Columbus, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Northwest Community Hospital
Arlington Heights, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, United States
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, United States
Center for Cancer Care at OSF Saint Anthony Medical Center
Rockford, Illinois, United States
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States
Saint John's Cancer Center at Saint John's Medical Center
Anderson, Indiana, United States
Radiation Oncology Associates Southwest
Fort Wayne, Indiana, United States
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, United States
Veterans Affairs Medical Center - Indianapolis
Indianapolis, Indiana, United States
Central Indiana Cancer Centers - East
Indianapolis, Indiana, United States
McFarland Clinic, PC
Ames, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, United States
Norton Suburban Hospital
Louisville, Kentucky, United States
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, United States
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States
Suburban Hospital
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River, Massachusetts, United States
Shields Radiation Oncology Center - Mansfield
Mansfield, Massachusetts, United States
NSMC Cancer Center - Peabody
Peabody, Massachusetts, United States
South Suburban Oncology Center
Quincy, Massachusetts, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States
St. Luke's Hospital Cancer Care Center
Duluth, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States
Cancer Institute of Cape Girardeau, LLC
Cape Girardeau, Missouri, United States
St. John's Regional Medical Center
Joplin, Missouri, United States
Kansas City Cancer Centers - South
Kansas City, Missouri, United States
Kansas City Cancer Centers - North
Kansas City, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
Immanuel Medical Center
Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States
Creighton University Medical Center
Omaha, Nebraska, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
Dartmouth - Hitchcock Concord
Concord, New Hampshire, United States
Seacoast Cancer Center at Wentworth - Douglass Hospital
Dover, New Hampshire, United States
Center for Cancer Care at Exeter Hospital
Exeter, New Hampshire, United States
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, United States
Cancer Institute of New Jersey at Cooper University Hospital - Camden
Camden, New Jersey, United States
CentraState Medical Center
Freehold, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
Lovelace Medical Center - Downtown
Albuquerque, New Mexico, United States
New Mexico Cancer Center
Albuquerque, New Mexico, United States
Radiation Oncology Associates, PA
Albuquerque, New Mexico, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Cancer Institute of New Mexico
Santa Fe, New Mexico, United States
New York Oncology Hematology, PC at Albany Regional Cancer Care
Albany, New York, United States
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
Cooperstown, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
CaroMont Cancer Center at Gaston Memorial Hospital
Gastonia, North Carolina, United States
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, United States
High Point Regional Hospital
High Point, North Carolina, United States
New Hanover Radiation Oncology, PA
Wilmington, North Carolina, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States
Barberton Citizens Hospital
Barberton, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital
Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Cancer Care Center
Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
Middletown Regional Hospital
Franklin, Ohio, United States
Cleveland Clinic Cancer Center
Independence, Ohio, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
Northwest Ohio Oncology Center
Maumee, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States
St. Charles Mercy Hospital
Oregon, Ohio, United States
Cancer Care Center, Incorporated
Salem, Ohio, United States
Flower Hospital Cancer Center
Sylvania, Ohio, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States
Cancer Treatment Center
Wooster, Ohio, United States
Cleveland Clinic - Wooster
Wooster, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States
Willamette Valley Cancer Center - Eugene
Eugene, Oregon, United States
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Salem Hospital Regional Cancer Care Services
Salem, Oregon, United States
Celilo Cancer Center at Mid-Columbia Medical Center
The Dalles, Oregon, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States
UPMC Cancer Center at Beaver Medical Center
Beaver, Pennsylvania, United States
UPMC Cancer Center at Jefferson Regional Medical Center
Clairton, Pennsylvania, United States
Cancer Center at Clarion Hospital
Clarion, Pennsylvania, United States
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, United States
UPMC Cancer Center - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
UPMC Cancer Center at the John P. Murtha Pavilion
Johnstown, Pennsylvania, United States
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, United States
UPMC - Moon
Moon Township, Pennsylvania, United States
UPMC Cancer Center - Natrona Heights
Natrona Heights, Pennsylvania, United States
Jameson Memorial Hospital - North Campus
New Castle, Pennsylvania, United States
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
UPMC - Shadyside
Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at UPMC St. Margaret
Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at UPMC Passavant
Pittsburgh, Pennsylvania, United States
UPMC Cancer Center - Upper St. Clair
Pittsburgh, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Guthrie Cancer Center at Guthrie Clinic Sayre
Sayre, Pennsylvania, United States
Grand View Hospital
Sellersville, Pennsylvania, United States
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, United States
UPMC Cancer Center - Uniontown
Uniontown, Pennsylvania, United States
Washington Hospital Cancer Center
Washington, Pennsylvania, United States
CCOP - Main Line Health
Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
Texas Oncology, PA at Harris Center HEB
Bedford, Texas, United States
St. Joseph Regional Cancer Center
Bryan, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Texas Oncology, PA at Texas Cancer Center Dallas Southwest
Dallas, Texas, United States
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
Fort Worth, Texas, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Texas Oncology, PA at Texas Cancer Center - Sherman
Sherman, Texas, United States
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
Dixie Regional Medical Center - East Campus
St. George, Utah, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
Community Cancer Center at Rutland Regional Medical Center
Rutland, Vermont, United States
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
Madigan Army Medical Center - Tacoma
Tacoma, Washington, United States
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, United States
Theda Care Cancer Institute
Appleton, Wisconsin, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, United States
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States
Columbia-Saint Mary's Cancer Care Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee
Milwaukee, Wisconsin, United States
Vince Lombardi Cancer Clinic - Sheboygan
Sheboygan, Wisconsin, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada
Countries
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References
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Patel AR, Sandler HM, Pienta KJ. Radiation Therapy Oncology Group 0521: a phase III randomized trial of androgen suppression and radiation therapy versus androgen suppression and radiation therapy followed by chemotherapy with docetaxel/prednisone for localized, high-risk prostate cancer. Clin Genitourin Cancer. 2005 Dec;4(3):212-4. doi: 10.3816/cgc.2005.n.035. No abstract available.
Phillips RM, Proudfoot JA, Davicioni E, Liu Y, Spratt DE, Simko JM, Den RB, Pollack A, Rosenthal SA, Sartor AO, Sweeney CJ, Attard G, Longoria L, Patel S, Straza MW, Efstathiou JA, Shah AB, Hoffman KE, Rodgers JP, Sandler HM, Feng FY, Tran PT. Transcriptomic Analysis of Localized High-risk Prostate Cancer Improves Prognostication and Identifies Benefit from Adding Docetaxel to Definitive Radiotherapy with Androgen Suppression in the NRG Oncology/RTOG 0521 Phase 3 Trial. Eur Urol Oncol. 2025 Aug;8(4):968-976. doi: 10.1016/j.euo.2025.04.009. Epub 2025 Jul 17.
Flannery BT, Sandler HM, Lal P, Feldman MD, Santa-Rosario JC, Pathak T, Mirtti T, Farre X, Correa R, Chafe S, Shah A, Efstathiou JA, Hoffman K, Hallman MA, Straza M, Jordan R, Pugh SL, Feng F, Madabhushi A. Stress testing deep learning models for prostate cancer detection on biopsies and surgical specimens. J Pathol. 2025 Feb;265(2):146-157. doi: 10.1002/path.6373. Epub 2024 Dec 11.
Study Documents
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Document Type: Individual Participant Data Set
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View DocumentOther Identifiers
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CDR0000462375
Identifier Type: -
Identifier Source: secondary_id
NCI-2009-00728
Identifier Type: REGISTRY
Identifier Source: secondary_id
RTOG-0521
Identifier Type: -
Identifier Source: org_study_id
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