Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy

NCT00002874 | Completed Phase 3 Results DMC

• 3 other identifiers: RTOG-9601CDR0000065158RTOG-R9601
• Study Type: interventional
• Target: 840
• Locations: 2 countries
• Sites: 240

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.

Conditions

Prostate Cancer

Keywords

stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (12-year Rates Reported)

  Overall survival rates were estimated by the Kaplan-Meier method, with failure defined as death by any cause. Four-year follow-up was required of all patients, twelve-year rates are reported. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.

  From date of randomization to 12 years.

Secondary Outcomes (8)

• Non-Prostate Cancer Death (12-year Rates Reported)

  From date of randomization to 12 years.

• Second PSA Recurrence (12-year Rates Reported)

  From date of randomization to 12 years.

• Third PSA Recurrence (12-year Rates Reported)

  From start of salvage hormone therapy to 12 years.

• PSA Complete Response at End of Protocol Treatment

  End of protocol treatment, which is planned to last for two years

• Distant Failure (12-year Rates Reported)

  From date of randomization to 12 years.

Study Arms (2)

Bicalutamide

EXPERIMENTAL

Radiation therapy + bicalutamide

Drug: bicalutamide; Radiation: radiation therapy

Placebo

PLACEBO COMPARATOR

Radiation therapy + placebo

Radiation: radiation therapy; Drug: placebo

Interventions

bicalutamide DRUG

One (150 mg) tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.

Also known as: Casodex

Bicalutamide

radiation therapy RADIATION

64.8 Gy in 36 fractions (1.8 Gy in 5 daily sessions per week) to the original prostate volume, the tumor resection bed, and the proximal membranous urethra.

Bicalutamide; Placebo

placebo DRUG

One tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.

Placebo

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Conditions for Patient Eligibility: * The patient on entry will have no clinical evidence of disease by physical exam or by imaging studies. A positive ProstaScint scan alone without a confirmatory biopsy must not be used to exclude a patient. Eligible patients will be those who have undergone a radical prostatectomy (either retropubic or perineal) and pelvic lymphadenectomy (either open or laparoscopic) for carcinoma of the prostate, pathologic stage T3N0, or pT2 pN0 with positive inked resection margin, at least 12 weeks prior to study entry. * Pathological T2 patients without positive margins, who are also pathologic N0 with prostatic fossa/anastamosis biopsy at the time of rising PSA documenting recurrent cancer, are eligible. * At entry, the PSA must be between 0.2 and 4.0ng/ml, inclusive. * A post-prostatectomy radioisotopic bone scan which was done within 16 weeks prior to entry must reveal no evidence of metastatic disease. * Patient must be evaluated by both the radiation oncologist and the urologist prior to entry and judged to be a suitable candidate for radiation and hormonal therapy. * Patient must have Karnofsky performance status \>= 80. * Patients must have a life expectancy in excess of 10 years. * Patients must have, within 6 weeks prior to entry, a hemoglobin (Hgb) of \>=10 gm, a white blood cell (WBC) count of \>= 4000 cells/ml3, a platelet count of \>= 100,000 cells/ml3, a serum bilirubin \<= the institutional upper limit of normal, a serum serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) of \<= 2.5 times the institutional upper limit of normal, and a serum creatinine of \<= 2.0 times the institutional upper limit of normal. * A post-prostatectomy pelvic computerized tomography (CT) scan, within 16 weeks prior to randomization, must reveal no evidence of metastatic disease. * Patients must sign a study-specific informed consent form. * Patients with prior invasive cancers are eligible if disease free for at least 5 years; prior or concurrent basal or squamous cell skin cancer is eligible. Conditions for Patient Ineligibility: * Pathologic stage T2 (without positive inked resection margin) or less except as stated in Section 3.1.1.1. * Pathologic lymph node stage of pN1 or greater. * An entry serum PSA of \> 4.0ng/ml. * Patients with persistant urinary extravasation after prostatectomy. * Patients who have been previously treated with any hormonal therapy after prostatectomy. * Patients who have previously been treated with radiation therapy or biologic therapy for prostate cancer. * Karnofsky performance status \< 80. * Treatment start \> 4 weeks after randomization. * Prior chemotherapy for any reason.

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
• SWOG Cancer Research Network: collaborator
• NRG Oncology: collaborator

Study Sites (240)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

Comprehensive Cancer Institute of Huntsville

Huntsville, Alabama, 35801, United States

Location

Huntsville Hospital System

Huntsville, Alabama, 35807, United States

Location

MBCCOP - Gulf Coast

Mobile, Alabama, 36688, United States

Location

Alabama Oncology, LLC

Montgomery, Alabama, 36106-3657, United States

Location

Radiation Oncology Associates of West Alabama

Tuscaloosa, Alabama, 35401, United States

Location

Foundation for Cancer Research and Education

Phoenix, Arizona, 85013, United States

Location

Mount Diablo Medical Center

Concord, California, 94524-4110, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Saint Agnes Cancer Center

Fresno, California, 93720, United States

Location

California Cancer Center

Fresno, California, 93729-5100, United States

Location

Sutter Health West Cancer Research Group

Greenbrae, California, 94904, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Veterans Affairs Medical Center - Long Beach

Long Beach, California, 90822, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90025-1781, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609-3305, United States

Location

Huntington Cancer Center

Pasadena, California, 91105, United States

Location

Cancer Care Center

Pomona, California, 91767, United States

Location

Radiation Oncology Center - Sacramento

Sacramento, California, 95816, United States

Location

Radiation Medical Group, Inc.

San Diego, California, 92101, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

O'Connor Hospital

San Jose, California, 95128, United States

Location

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, 95403, United States

Location

David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

Memorial Hospital Cancer Center

Colorado Springs, Colorado, 80909, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80010, United States

Location

Saint Mary's Hospital and Medical Center

Grand Junction, Colorado, 81502-1628, United States

Location

Hospital of St. Raphael

New Haven, Connecticut, 06511, United States

Location

CCOP - Christiana Care Health Services

Wilmington, Delaware, 19899, United States

Location

University of Florida Health Science Center

Gainesville, Florida, 32610-0385, United States

Location

Florida Radiation Oncology Group

Jacksonville, Florida, 32207, United States

Location

Health First Holmes Regional Medical Center

Melbourne, Florida, 32901-3276, United States

Location

Veterans Affairs Medical Center - Miami

Miami, Florida, 33125, United States

Location

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33256-2110, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

MD Anderson Cancer Center Orlando

Orlando, Florida, 32806, United States

Location

Bay Medical Center

Panama City, Florida, 32401, United States

Location

Gulf Coast Cancer Treatment Center

Panama City, Florida, 32405-4587, United States

Location

Sarasota Radiation and Medical Oncology Center

Sarasota, Florida, 34233, United States

Location

Tallahassee Memorial Healthcare

Tallahassee, Florida, 32308, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

Medical Center/John B. Amos Community Cancer Center

Columbus, Georgia, 31901, United States

Location

Regional Radiation Oncology Center at Rome

Rome, Georgia, 30165, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

Northwest Community Hospital

Arlington Heights, Illinois, 60005, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

St. John's Medical Center

Anderson, Indiana, 46016, United States

Location

Bloomington Hospital

Bloomington, Indiana, 47402, United States

Location

Veterans Affairs Medical Center - Indianapolis (Roudebush)

Indianapolis, Indiana, 46202, United States

Location

Clarian Health Partners Inc.

Indianapolis, Indiana, 46206-1367, United States

Location

Regional Cancer Center

Indianapolis, Indiana, 46219, United States

Location

Ball Memorial Hospital

Muncie, Indiana, 47303-3499, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Wendt Regional Cancer Center of Finley Hospital

Dubuque, Iowa, 52001, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Cancer Center at Lexington Clinic

Lexington, Kentucky, 40504, United States

Location

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0084, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Louisville Radiation Oncology

Louisville, Kentucky, 40215, United States

Location

Merle M. Mahr Cancer Center

Madisonville, Kentucky, 42431, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112-2699, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Anne Arundel Oncology Center

Annapolis, Maryland, 21401, United States

Location

Marlene and Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Greater Baltimore Medical Center and Cancer Center

Baltimore, Maryland, 21204, United States

Location

Harbor Hospital Center

Baltimore, Maryland, 21215-1290, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Peninsula Regional Medical Center

Salisbury, Maryland, 21801, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Cape Cod Hospital

Hyannis, Massachusetts, 02601, United States

Location

Veterans Affairs Medical Center - Boston (Jamaica Plain)

Jamaica Plain, Massachusetts, 02130, United States

Location

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

McLaren Regional Cancer Center

Flint, Michigan, 48532-3685, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

Marquette General Hospital

Marquette, Michigan, 49855, United States

Location

MidMichigan Medical Center - Midland

Midland, Michigan, 48670, United States

Location

CCOP - Beaumont

Royal Oak, Michigan, 48073-6769, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital - Troy

Troy, Michigan, 48098, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Ellis Fischel Cancer Center - Columbia

Columbia, Missouri, 65203, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

Mallinckrodt Institute of Radiology

St Louis, Missouri, 63108, United States

Location

St. Louis University Health Sciences Center

St Louis, Missouri, 63110-0250, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Methodist Cancer Center - Omaha

Omaha, Nebraska, 68114, United States

Location

Nebraska Health System

Omaha, Nebraska, 68198-7460, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Elliot Regional Cancer Center

Manchester, New Hampshire, 03103, United States

Location

Cooper Cancer Institute

Camden, New Jersey, 01803, United States

Location

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, 07019, United States

Location

John F. Kennedy Medical Center

Edison, New Jersey, 08818, United States

Location

Trinitas Hospital - Jersey Street Campus

Elizabeth, New Jersey, 07201, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740-6395, United States

Location

South Jersey Regional Cancer Center

Millville, New Jersey, 08332, United States

Location

Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County

Mount Holly, New Jersey, 08060, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 38103-2807, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Atlantic City Medical Center

Pomona, New Jersey, 08240, United States

Location

Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Somerset Medical Center

Somerville, New Jersey, 08876, United States

Location

Community Medical Center

Toms River, New Jersey, 08755, United States

Location

Capital Health System at Mercer

Trenton, New Jersey, 08618, United States

Location

St. Francis Medical Center

Trenton, New Jersey, 08629, United States

Location

Associated Radiologists, P.A.

Warren Township, New Jersey, 07059, United States

Location

Radiation Oncology Associates of Albuquerque

Albuquerque, New Mexico, 87109, United States

Location

Cancer Center of Albany Medical Center

Albany, New York, 12208, United States

Location

State University of New York Health Science Center at Brooklyn

Brooklyn, New York, 11203, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Finger Lakes Radiation Oncology Center

Clifton Springs, New York, 14432, United States

Location

CCOP - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Champlain Valley Physicians Hospital Medical Center

Plattsburgh, New York, 12901, United States

Location

Vassar Brothers Medical Center

Poughkeepsie, New York, 12601, United States

Location

James P. Wilmot Cancer Center

Rochester, New York, 14642, United States

Location

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

Syracuse, New York, 13217, United States

Location

Riverhill Radiation Oncology

Yonkers, New York, 10701, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Northeast Medical Center

Concord, North Carolina, 28025, United States

Location

East Carolina University School of Medicine

Greenville, North Carolina, 27858-4354, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Trinity Cancer Care Center

Minot, North Dakota, 58701, United States

Location

Akron General Medical Center

Akron, Ohio, 44302, United States

Location

Akron City Hospital

Akron, Ohio, 44304, United States

Location

Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Barrett Cancer Center

Cincinnati, Ohio, 45267-0502, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

CCOP - Dayton

Kettering, Ohio, 45429, United States

Location

St. Anthony Hospital

Oklahoma City, Oklahoma, 73101, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

St. John Health System

Tulsa, Oklahoma, 74104, United States

Location

CCOP - Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

CCOP - Columbia River Program

Portland, Oregon, 97225, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18105, United States

Location

St. Luke's Hospital Cancer Center

Bethlehem, Pennsylvania, 18015, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Mercy Fitzgerald Hospital

Darby, Pennsylvania, 19023, United States

Location

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026, United States

Location

Pocono Cancer Center

East Stroudsburg, Pennsylvania, 18301, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Veterans Affairs Medical Center - Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141-3098, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489, United States

Location

Mercy Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Mercy Hospital Cancer Center - Scranton

Scranton, Pennsylvania, 18501, United States

Location

Wilkes Barre General Hospital

Wilkes-Barre, Pennsylvania, 18764, United States

Location

York Hospital

York, Pennsylvania, 17315, United States

Location

Roger Williams Medical Center/BUSM

Providence, Rhode Island, 02908-4735, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

Jackson-Madison County General Hospital

Jackson, Tennessee, 38301-3956, United States

Location

University of Tennessee Cancer Institute

Memphis, Tennessee, 38103, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-5671, United States

Location

Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0209, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236-5300, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410-1894, United States

Location

Bayshore Medical Center

Pasadena, Texas, 77504, United States

Location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

Latter Day Saints Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Regional Medical Center

St. George, Utah, 84770, United States

Location

Green Mountain Oncology Group

Bennington, Vermont, 05201, United States

Location

Vermont Cancer Center

Burlington, Vermont, 05401, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

RMH Regional Cancer Center

Harrisonburg, Virginia, 22801, United States

Location

Naval Medical Center, Portsmouth

Portsmouth, Virginia, 23708-2197, United States

Location

Bon-Secours - St. Mary's Hospital

Richmond, Virginia, 23226, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98111, United States

Location

Deaconess Medical Center

Spokane, Washington, 99210-0248, United States

Location

Yakima Valley Memorial Hospital

Yakima, Washington, 98902, United States

Location

Schiffler Cancer Center

Wheeling, West Virginia, 26003, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

St. Vincent Hospital

Green Bay, Wisconsin, 54307-3508, United States

Location

Gundersen Lutheran Medical Foundation

La Crosse, Wisconsin, 54601, United States

Location

Southern Wisconsin Radiotherapy Center

Madison, Wisconsin, 53713, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

Community Memorial Hospital

Menomonee Falls, Wisconsin, 53051, United States

Location

Columbia Hospital

Milwaukee, Wisconsin, 53211, United States

Location

St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, 53295, United States

Location

All Saints Cancer Center

Racine, Wisconsin, 53405, United States

Location

Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188, United States

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Newfoundland Cancer Treatment and Research Foundation

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Northeastern Ontario Regional Cancer Centre, Sudbury

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Kingston Regional Cancer Centre

Kingston, Ontario, K7L 5P9, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Northwestern Ontario Regional Cancer Centre, Thunder Bay

Thunder Bay, Ontario, P7A 7T1, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CHUS-Hopital Fleurimont

Fleurimont, Quebec, J1H 5N4, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2L 4MI, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (6)

• Shipley WU, Seiferheld W, Lukka HR, Major PP, Heney NM, Grignon DJ, Sartor O, Patel MP, Bahary JP, Zietman AL, Pisansky TM, Zeitzer KL, Lawton CA, Feng FY, Lovett RD, Balogh AG, Souhami L, Rosenthal SA, Kerlin KJ, Dignam JJ, Pugh SL, Sandler HM; NRG Oncology RTOG. Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer. N Engl J Med. 2017 Feb 2;376(5):417-428. doi: 10.1056/NEJMoa1607529.

  PMID: 28146658 RESULT

• Brodowsky EC, Sood A, Butaney M, Majdalany SE, Stephens A, Corsi N, Piontkowski AJ, Rakic I, Jamil M, Dalela D, Peabody JO, Rogers CG, Abdollah F. Time to second biochemical recurrence as a prognostic indicator in postprostatectomy patients who undergo salvage radiation therapy: An RTOG 9601 based post hoc analysis. Prostate. 2023 Jan;83(1):64-70. doi: 10.1002/pros.24436. Epub 2022 Sep 19.

  PMID: 36120850 DERIVED

• Modonutti D, Majdalany SE, Corsi N, Li P, Sood A, Dalela D, Jamil ML, Hwang C, Menon M, Rogers CG, Trinh QD, Novara G, Abdollah F. A novel prognostic model predicting overall survival in patients with metastatic castration-resistant prostate cancer receiving standard chemotherapy: A multi-trial cohort analysis. Prostate. 2022 Sep;82(13):1293-1303. doi: 10.1002/pros.24403. Epub 2022 Jul 5.

  PMID: 35790016 DERIVED

• Jackson WC, Tang M, Schipper MJ, Sandler HM, Zumsteg ZS, Efstathiou JA, Shipley WU, Seiferheld W, Lukka HR, Bahary JP, Zietman AL, Pisansky TM, Zeitzer KL, Hall WA, Dess RT, Lovett RD, Balogh AG, Feng FY, Spratt DE. Biochemical Failure Is Not a Surrogate End Point for Overall Survival in Recurrent Prostate Cancer: Analysis of NRG Oncology/RTOG 9601. J Clin Oncol. 2022 Sep 20;40(27):3172-3179. doi: 10.1200/JCO.21.02741. Epub 2022 Jun 23.

  PMID: 35737923 DERIVED

• Feng FY, Huang HC, Spratt DE, Zhao SG, Sandler HM, Simko JP, Davicioni E, Nguyen PL, Pollack A, Efstathiou JA, Dicker AP, Todorovic T, Margrave J, Liu YS, Dabbas B, Thompson DJS, Das R, Dignam JJ, Sweeney C, Attard G, Bahary JP, Lukka HR, Hall WA, Pisansky TM, Shah AB, Pugh SL, Shipley WU, Tran PT. Validation of a 22-Gene Genomic Classifier in Patients With Recurrent Prostate Cancer: An Ancillary Study of the NRG/RTOG 9601 Randomized Clinical Trial. JAMA Oncol. 2021 Apr 1;7(4):544-552. doi: 10.1001/jamaoncol.2020.7671.

  PMID: 33570548 DERIVED

• Dess RT, Sun Y, Jackson WC, Jairath NK, Kishan AU, Wallington DG, Mahal BA, Stish BJ, Zumsteg ZS, Den RB, Hall WA, Gharzai LA, Jaworski EM, Reichert ZR, Morgan TM, Mehra R, Schaeffer EM, Sartor O, Nguyen PL, Lee WR, Rosenthal SA, Michalski JM, Schipper MJ, Dignam JJ, Pisansky TM, Zietman AL, Sandler HM, Efstathiou JA, Feng FY, Shipley WU, Spratt DE. Association of Presalvage Radiotherapy PSA Levels After Prostatectomy With Outcomes of Long-term Antiandrogen Therapy in Men With Prostate Cancer. JAMA Oncol. 2020 May 1;6(5):735-743. doi: 10.1001/jamaoncol.2020.0109.

  PMID: 32215583 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; Radiotherapy

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)

Therapeutics

Results Point of Contact

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

seiferheldw@nrgoncology.org

Study Officials

• William U. Shipley, MD

  Massachusetts General Hospital and Harvard Medical School, Boston

  PRINCIPAL INVESTIGATOR

• Himanshu R Lukka, MD

  Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON

  STUDY CHAIR

• Pierre P Major, MD

  Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON

  STUDY CHAIR

• Niall M Heney, MD

  Massachusetts General Hospital and Harvard Medical School, Boston

  STUDY CHAIR

• David J Grignon, MD

  Indiana University, Indianapolis

  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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: February 1, 1998
• Primary Completion: August 1, 2015
• Study Completion: May 20, 2022
• Last Updated: June 15, 2022
• Results First Posted: August 18, 2017

Record last verified: 2022-05

Locations

US (221); CA (19)