Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer

NCT00288080 | Completed Phase 3 Results DMC

• 3 other identifiers: RTOG-0521CDR0000462375NCI-2009-00728
• Study Type: interventional
• Target: 612
• Locations: 2 countries
• Sites: 254

Brief Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving hormone therapy and radiation therapy together with chemotherapy is more effective than giving hormone therapy together with radiation therapy in treating prostate cancer. 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.

Conditions

Prostate Cancer

Keywords

stage III prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Four-year rates are shown. Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

  From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

Secondary Outcomes (7)

• Biochemical Control

  From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

• Local Control

  From randomization to date of local failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

• Distant Metastasis

  From randomization to date of distant metastasis, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

• Disease-free Survival

  From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

• Incidence of Adverse Events

  From start of treatment until the end of follow-up

Study Arms (2)

Androgen suppression + Radiation Therapy

ACTIVE COMPARATOR

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).

Drug: Oral antiandrogen; Radiation: Radiation therapy; Drug: LHRH agonist

Androgen suppression + Radiation Therapy + Chemotherapy

EXPERIMENTAL

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.

Drug: Dexamethasone; Drug: Prednisone; Drug: docetaxel; Drug: Oral antiandrogen; Radiation: Radiation therapy; Drug: LHRH agonist

Interventions

Dexamethasone DRUG

Premedication of dexamethasone prior to docetaxel, per institutional standards.

Androgen suppression + Radiation Therapy + Chemotherapy

Prednisone DRUG

10 mg orally per day until day 21 of the last cycle of docetaxel, beginning 28 days after the completion of RT.

Androgen suppression + Radiation Therapy + Chemotherapy

docetaxel DRUG

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.

Androgen suppression + Radiation Therapy + Chemotherapy

Oral antiandrogen DRUG

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.

Androgen suppression + Radiation Therapy; Androgen suppression + Radiation Therapy + Chemotherapy

Radiation therapy RADIATION

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.

Also known as: 3DCRT, Three-dimensional conformal radiotherapy, IMRT, Intensity-modulated radiation therapy

Androgen suppression + Radiation Therapy; Androgen suppression + Radiation Therapy + Chemotherapy

LHRH agonist DRUG

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; Androgen suppression + Radiation Therapy + Chemotherapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• NRG Oncology: collaborator

Study Sites (254)

UAB Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Providence Cancer Center

Anchorage, Alaska, 99508, United States

Location

Arizona Oncology Services Foundation

Phoenix, Arizona, 85013, United States

Location

Arizona Oncology - Tucson

Tucson, Arizona, 85704, United States

Location

Auburn Radiation Oncology

Auburn, California, 95603, United States

Location

Providence Saint Joseph Medical Center - Burbank

Burbank, California, 91505, United States

Location

Radiation Oncology Centers - Cameron Park

Cameron Park, California, 95682, United States

Location

Mercy Cancer Center at Mercy San Juan Medical Center

Carmichael, California, 95608, United States

Location

Enloe Cancer Center at Enloe Medical Center

Chico, California, 95926, United States

Location

Cancer Care Center at John Muir Health - Concord Campus

Concord, California, 94524-4110, United States

Location

Washington Township Hospital

Fremont, California, 94538, United States

Location

Sierra Nevada Cancer Center at Sierra Nevada Memorial Hospital

Grass Valley, California, 95945, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Memorial Medical Center

Modesto, California, 95355, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center

Rancho Mirage, California, 92270, United States

Location

Radiation Oncology Center - Roseville

Roseville, California, 95661, United States

Location

Radiological Associates of Sacramento Medical Group, Incorporated

Sacramento, California, 95815, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

California Pacific Medical Center - California Campus

San Francisco, California, 94118, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90509, United States

Location

Solano Radiation Oncology Center

Vacaville, California, 95687, United States

Location

John Muir/Mt. Diablo Comprehensive Cancer Center

Walnut Creek, California, 94598, United States

Location

Rocky Mountain Cancer Centers - Aurora

Aurora, Colorado, 80012, United States

Location

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Swedish Medical Center

Englewood, Colorado, 80110, United States

Location

Poudre Valley Radiation Oncology

Fort Collins, Colorado, 80528, United States

Location

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

Grand Junction, Colorado, 81502, United States

Location

North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

McKee Medical Center

Loveland, Colorado, 80539, United States

Location

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, 80033, United States

Location

St. Vincent's Medical Center

Bridgeport, Connecticut, 06606, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Hospital of Saint Raphael

New Haven, Connecticut, 06511, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

William W. Backus Hospital

Norwich, Connecticut, 06360, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0232, United States

Location

Bay Medical

Panama City, Florida, 32401, United States

Location

Georgia Cancer Center for Excellence at Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

John B. Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31403-3089, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

Northwest Community Hospital

Arlington Heights, Illinois, 60005, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Elmhurst Memorial Hospital

Elmhurst, Illinois, 60126, United States

Location

Advocate Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068-1174, United States

Location

Center for Cancer Care at OSF Saint Anthony Medical Center

Rockford, Illinois, 61108, United States

Location

Cancer Institute at St. John's Hospital

Springfield, Illinois, 62702, United States

Location

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

Saint John's Cancer Center at Saint John's Medical Center

Anderson, Indiana, 46016, United States

Location

Radiation Oncology Associates Southwest

Fort Wayne, Indiana, 46804, United States

Location

Parkview Regional Cancer Center at Parkview Health

Fort Wayne, Indiana, 46805, United States

Location

Veterans Affairs Medical Center - Indianapolis

Indianapolis, Indiana, 46202, United States

Location

Central Indiana Cancer Centers - East

Indianapolis, Indiana, 46219, United States

Location

McFarland Clinic, PC

Ames, Iowa, 50010, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Kansas City Cancer Centers - Southwest

Overland Park, Kansas, 66210, United States

Location

Norton Suburban Hospital

Louisville, Kentucky, 40207, United States

Location

Tulane Cancer Center Office of Clinical Research

Alexandria, Louisiana, 71315-3198, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

Maine Center for Cancer Medicine and Blood Disorders - Scarborough

Scarborough, Maine, 04074, United States

Location

DeCesaris Cancer Institute at Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

St. Agnes Hospital Cancer Center

Baltimore, Maryland, 21229, United States

Location

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Hudner Oncology Center at Saint Anne's Hospital - Fall River

Fall River, Massachusetts, 02721, United States

Location

Shields Radiation Oncology Center - Mansfield

Mansfield, Massachusetts, 02048, United States

Location

NSMC Cancer Center - Peabody

Peabody, Massachusetts, 01960, United States

Location

South Suburban Oncology Center

Quincy, Massachusetts, 02169, United States

Location

Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, 49221, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

Breslin Cancer Center at Ingham Regional Medical Center

Lansing, Michigan, 48910, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

St. Luke's Hospital Cancer Care Center

Duluth, Minnesota, 55805, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Minnesota Oncology Hematology, PA - Maplewood

Maplewood, Minnesota, 55109, United States

Location

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

Robbinsdale, Minnesota, 55422-2900, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, 39581, United States

Location

Cancer Institute of Cape Girardeau, LLC

Cape Girardeau, Missouri, 63703, United States

Location

St. John's Regional Medical Center

Joplin, Missouri, 64804, United States

Location

Kansas City Cancer Centers - South

Kansas City, Missouri, 64131, United States

Location

Kansas City Cancer Centers - North

Kansas City, Missouri, 64154, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

David C. Pratt Cancer Center at St. John's Mercy

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Great Falls Clinic - Main Facility

Great Falls, Montana, 59405, United States

Location

Sletten Cancer Institute at Benefis Healthcare

Great Falls, Montana, 59405, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Methodist Estabrook Cancer Center

Omaha, Nebraska, 68114, United States

Location

Immanuel Medical Center

Omaha, Nebraska, 68122, United States

Location

Alegant Health Cancer Center at Bergan Mercy Medical Center

Omaha, Nebraska, 68124, United States

Location

Creighton University Medical Center

Omaha, Nebraska, 68131-2197, United States

Location

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

Dartmouth - Hitchcock Concord

Concord, New Hampshire, 03301, United States

Location

Seacoast Cancer Center at Wentworth - Douglass Hospital

Dover, New Hampshire, 03820, United States

Location

Center for Cancer Care at Exeter Hospital

Exeter, New Hampshire, 03833, United States

Location

Kingsbury Center for Cancer Care at Cheshire Medical Center

Keene, New Hampshire, 03431, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Elliot Regional Cancer Center at Elliot Hospital

Manchester, New Hampshire, 03103, United States

Location

Cancer Institute of New Jersey at Cooper University Hospital - Camden

Camden, New Jersey, 08103, United States

Location

CentraState Medical Center

Freehold, New Jersey, 07728, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

Marlton, New Jersey, 08053, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Lovelace Medical Center - Downtown

Albuquerque, New Mexico, 87102, United States

Location

New Mexico Cancer Center

Albuquerque, New Mexico, 87109, United States

Location

Radiation Oncology Associates, PA

Albuquerque, New Mexico, 87109, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131-5636, United States

Location

Cancer Institute of New Mexico

Santa Fe, New Mexico, 87505, United States

Location

New York Oncology Hematology, PC at Albany Regional Cancer Care

Albany, New York, 12206, United States

Location

Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital

Cooperstown, New York, 13326, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Veterans Affairs Medical Center - Syracuse

Syracuse, New York, 13210, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233-3549, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

CaroMont Cancer Center at Gaston Memorial Hospital

Gastonia, North Carolina, 28053, United States

Location

Leo W. Jenkins Cancer Center at ECU Medical School

Greenville, North Carolina, 27834, United States

Location

High Point Regional Hospital

High Point, North Carolina, 27261, United States

Location

New Hanover Radiation Oncology, PA

Wilmington, North Carolina, 28401, United States

Location

Forsyth Regional Cancer Center at Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Summa Center for Cancer Care at Akron City Hospital

Akron, Ohio, 44309-2090, United States

Location

Barberton Citizens Hospital

Barberton, Ohio, 44203, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic Cancer Center at Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45406, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Cancer Care Center

Dayton, Ohio, 45415, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

Location

Cleveland Clinic Cancer Center

Independence, Ohio, 44131, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

Lima Memorial Hospital

Lima, Ohio, 45804, United States

Location

Northwest Ohio Oncology Center

Maumee, Ohio, 43537-1839, United States

Location

Hillcrest Cancer Center at Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States

Location

St. Charles Mercy Hospital

Oregon, Ohio, 43616, United States

Location

Cancer Care Center, Incorporated

Salem, Ohio, 44460, United States

Location

Flower Hospital Cancer Center

Sylvania, Ohio, 43560, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

Medical University of Ohio Cancer Center

Toledo, Ohio, 43614, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43617, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373-1300, United States

Location

Cancer Treatment Center

Wooster, Ohio, 44691, United States

Location

Cleveland Clinic - Wooster

Wooster, Ohio, 44691, United States

Location

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, 74136, United States

Location

Willamette Valley Cancer Center - Eugene

Eugene, Oregon, 97401, United States

Location

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Salem Hospital Regional Cancer Care Services

Salem, Oregon, 97309-5014, United States

Location

Celilo Cancer Center at Mid-Columbia Medical Center

The Dalles, Oregon, 97058, United States

Location

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

UPMC Cancer Center at Beaver Medical Center

Beaver, Pennsylvania, 15009, United States

Location

UPMC Cancer Center at Jefferson Regional Medical Center

Clairton, Pennsylvania, 15025, United States

Location

Cancer Center at Clarion Hospital

Clarion, Pennsylvania, 16214, United States

Location

Mercy Fitzgerald Hospital

Darby, Pennsylvania, 19023, United States

Location

Delaware County Regional Cancer Center at Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026, United States

Location

Northeast Radiation Oncology Center

Dunmore, Pennsylvania, 18512, United States

Location

UPMC Cancer Center - Arnold Palmer Pavilion

Greensburg, Pennsylvania, 15601, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

UPMC Cancer Center at the John P. Murtha Pavilion

Johnstown, Pennsylvania, 15901, United States

Location

UPMC Cancer Center at UPMC McKeesport

McKeesport, Pennsylvania, 15132, United States

Location

UPMC - Moon

Moon Township, Pennsylvania, 15108, United States

Location

UPMC Cancer Center - Natrona Heights

Natrona Heights, Pennsylvania, 15065, United States

Location

Jameson Memorial Hospital - North Campus

New Castle, Pennsylvania, 16105, United States

Location

Cancer Center of Paoli Memorial Hospital

Paoli, Pennsylvania, 19301-1792, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

UPMC - Shadyside

Pittsburgh, Pennsylvania, 15213-2582, United States

Location

UPMC Cancer Center at Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Cancer Center at UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Cancer Center at UPMC St. Margaret

Pittsburgh, Pennsylvania, 15215, United States

Location

UPMC Cancer Center at UPMC Passavant

Pittsburgh, Pennsylvania, 15237, United States

Location

UPMC Cancer Center - Upper St. Clair

Pittsburgh, Pennsylvania, 15243, United States

Location

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Guthrie Cancer Center at Guthrie Clinic Sayre

Sayre, Pennsylvania, 18840, United States

Location

Grand View Hospital

Sellersville, Pennsylvania, 18960, United States

Location

UPMC Cancer Center at UPMC Northwest

Seneca, Pennsylvania, 16346, United States

Location

UPMC Cancer Center - Uniontown

Uniontown, Pennsylvania, 15401, United States

Location

Washington Hospital Cancer Center

Washington, Pennsylvania, 15301, United States

Location

CCOP - Main Line Health

Wynnewood, Pennsylvania, 19096, United States

Location

Lankenau Cancer Center at Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

York Cancer Center at Apple Hill Medical Center

York, Pennsylvania, 17405, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Thompson Cancer Survival Center

Knoxville, Tennessee, 37916, United States

Location

Texas Oncology, PA at Harris Center HEB

Bedford, Texas, 76022, United States

Location

St. Joseph Regional Cancer Center

Bryan, Texas, 77802, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Texas Oncology, PA at Texas Cancer Center Dallas Southwest

Dallas, Texas, 75237, United States

Location

Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital

Fort Worth, Texas, 76104, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Texas Oncology, PA at Texas Cancer Center - Sherman

Sherman, Texas, 75090, United States

Location

Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land

Sugar Land, Texas, 77479, United States

Location

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

Murray, Utah, 84157, United States

Location

Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

Dixie Regional Medical Center - East Campus

St. George, Utah, 84770, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05401, United States

Location

Community Cancer Center at Rutland Regional Medical Center

Rutland, Vermont, 05701, United States

Location

Naval Medical Center - Portsmouth

Portsmouth, Virginia, 23708-2197, United States

Location

Veterans Affairs Medical Center - Richmond

Richmond, Virginia, 23249, United States

Location

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Providence Cancer Center at Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405, United States

Location

Madigan Army Medical Center - Tacoma

Tacoma, Washington, 98431, United States

Location

West Virginia University Health Sciences Center - Charleston

Charleston, West Virginia, 25304, United States

Location

Theda Care Cancer Institute

Appleton, Wisconsin, 54911, United States

Location

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54301-3526, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-3508, United States

Location

Gundersen Lutheran Center for Cancer and Blood

La Crosse, Wisconsin, 54601, United States

Location

Bay Area Cancer Care Center at Bay Area Medical Center

Marinette, Wisconsin, 54143, United States

Location

Community Memorial Hospital Cancer Care Center

Menomonee Falls, Wisconsin, 53051, United States

Location

Columbia Saint Mary's Hospital - Ozaukee

Mequon, Wisconsin, 53097, United States

Location

Columbia-Saint Mary's Cancer Care Center

Milwaukee, Wisconsin, 53211, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Veterans Affairs Medical Center - Milwaukee

Milwaukee, Wisconsin, 53295, United States

Location

Vince Lombardi Cancer Clinic - Sheboygan

Sheboygan, Wisconsin, 53081, United States

Location

University of Wisconcin Cancer Center at Aspirus Wausau Hospital

Wausau, Wisconsin, 54401, United States

Location

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, T6G 1Z2, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, K1Y 4K7, Canada

Location

Hopital Notre-Dame du CHUM

Montreal, Quebec, H2L 4M1, Canada

Location

McGill Cancer Centre at McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (3)

• 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.

  PMID: 16425991 RESULT

• 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.

  PMID: 40675873 DERIVED

• 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.

  PMID: 39660731 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dexamethasone; Prednisone; Docetaxel; Androgen Antagonists; Radiotherapy; Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated; Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pregnadienediols; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutics; Radiotherapy, Computer-Assisted; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Limitations and Caveats

Due to insufficient number of events, local control analysis was not conducted.

Results Point of Contact

• Title: Wendy Seiferheld, M.S.
• Organization: NRG Oncology

seiferheldw@nrgoncology.org

Study Officials

• Howard M. Sandler, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

• Seth Rosenthal, MD

  Radiological Associates of Sacramento Medical Group at Sutter Cancer Center

  STUDY CHAIR

• Mahul Amin, MD

  Cedars-Sinai Medical Center

  STUDY CHAIR

• Leonard G. Gomella, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  STUDY CHAIR

• James Purdy, PhD

  University of California, Davis

  STUDY CHAIR

• Jeff Michalski, MD

  Washington University School of Medicine

  STUDY CHAIR

• Mark Garzotto, MD

  Portland VA Medical Center

  STUDY CHAIR

• Oliver Sartor, MD

  Tulane School of Medicine

  STUDY CHAIR

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: February 6, 2006
• First Posted: February 7, 2006
• Study Start: December 1, 2005
• Primary Completion: April 1, 2014
• Study Completion: May 20, 2022
• Last Updated: June 21, 2022
• Results First Posted: January 23, 2017

Record last verified: 2022-05

Locations

US (245); CA (9)