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

PHASE3CompletedINTERVENTIONAL
Enrollment

840

Participants

Timeline

Start Date

February 28, 1998

Primary Completion Date

August 31, 2015

Study Completion Date

May 20, 2022

Conditions
Prostate Cancer
Interventions
DRUG

bicalutamide

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

RADIATION

radiation therapy

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.

DRUG

placebo

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

Trial Locations (240)

10032

Herbert Irving Comprehensive Cancer Center, New York

10701

Riverhill Radiation Oncology, Yonkers

11030

CCOP - North Shore University Hospital, Manhasset

11203

State University of New York Health Science Center at Brooklyn, Brooklyn

11215

New York Methodist Hospital, Brooklyn

12208

Cancer Center of Albany Medical Center, Albany

12601

Vassar Brothers Medical Center, Poughkeepsie

12901

Champlain Valley Physicians Hospital Medical Center, Plattsburgh

13217

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

14432

Finger Lakes Radiation Oncology Center, Clifton Springs

14642

James P. Wilmot Cancer Center, Rochester

15219

Mercy Hospital of Pittsburgh, Pittsburgh

15224

Western Pennsylvania Hospital, Pittsburgh

17315

York Hospital, York

18015

St. Luke's Hospital Cancer Center, Bethlehem

18105

Lehigh Valley Hospital, Allentown

18301

Pocono Cancer Center, East Stroudsburg

18501

Mercy Hospital Cancer Center - Scranton, Scranton

18764

Wilkes Barre General Hospital, Wilkes-Barre

19023

Mercy Fitzgerald Hospital, Darby

19026

Delaware County Memorial Hospital, Drexel Hill

19104

Veterans Affairs Medical Center - Philadelphia, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

19899

CCOP - Christiana Care Health Services, Wilmington

21201

Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore

21204

Greater Baltimore Medical Center and Cancer Center, Baltimore

21215

Sinai Hospital of Baltimore, Baltimore

21401

Anne Arundel Oncology Center, Annapolis

21801

Peninsula Regional Medical Center, Salisbury

22801

RMH Regional Cancer Center, Harrisonburg

22908

Cancer Center at the University of Virginia, Charlottesville

23226

Bon-Secours - St. Mary's Hospital, Richmond

26003

Schiffler Cancer Center, Wheeling

28025

Northeast Medical Center, Concord

29303

CCOP - Upstate Carolina, Spartanburg

29615

CCOP - Greenville, Greenville

30165

Regional Radiation Oncology Center at Rome, Rome

30322

Emory University Hospital - Atlanta, Atlanta

31901

Medical Center/John B. Amos Community Cancer Center, Columbus

32207

Florida Radiation Oncology Group, Jacksonville

32308

Tallahassee Memorial Healthcare, Tallahassee

32401

Bay Medical Center, Panama City

32806

MD Anderson Cancer Center Orlando, Orlando

33125

Veterans Affairs Medical Center - Miami, Miami

33136

Sylvester Cancer Center, University of Miami, Miami

33140

CCOP - Mount Sinai Medical Center, Miami Beach

34233

Sarasota Radiation and Medical Oncology Center, Sarasota

35401

Radiation Oncology Associates of West Alabama, Tuscaloosa

35801

Comprehensive Cancer Institute of Huntsville, Huntsville

35807

Huntsville Hospital System, Huntsville

36688

MBCCOP - Gulf Coast, Mobile

38103

University of Tennessee Cancer Institute, Memphis

40202

James Graham Brown Cancer Center, Louisville

40215

Louisville Radiation Oncology, Louisville

40503

Central Baptist Hospital, Lexington

40504

Cancer Center at Lexington Clinic, Lexington

42431

Merle M. Mahr Cancer Center, Madisonville

43206

CCOP - Columbus, Columbus

44106

University Hospitals of Cleveland, Cleveland

44195

Cleveland Clinic Taussig Cancer Center, Cleveland

44302

Akron General Medical Center, Akron

44304

Akron City Hospital, Akron

45219

Christ Hospital, Cincinnati

45429

CCOP - Dayton, Kettering

46016

St. John's Medical Center, Anderson

46202

Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis

46219

Regional Cancer Center, Indianapolis

46601

CCOP - Northern Indiana CR Consortium, South Bend

47402

Bloomington Hospital, Bloomington

48073

William Beaumont Hospital, Royal Oak

48098

William Beaumont Hospital - Troy, Troy

48106

CCOP - Ann Arbor Regional, Ann Arbor

48202

Henry Ford Hospital, Detroit

48503

Hurley Medical Center, Flint

48670

MidMichigan Medical Center - Midland, Midland

49855

Marquette General Hospital, Marquette

52001

Wendt Regional Cancer Center of Finley Hospital, Dubuque

53051

Community Memorial Hospital, Menomonee Falls

53188

Waukesha Memorial Hospital, Waukesha

53211

Columbia Hospital, Milwaukee

53215

St. Luke's Medical Center, Milwaukee

53226

Medical College of Wisconsin, Milwaukee

53295

Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee

53405

All Saints Cancer Center, Racine

53713

Southern Wisconsin Radiotherapy Center, Madison

53792

University of Wisconsin Comprehensive Cancer Center, Madison

54301

CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay

54449

Marshfield Clinic, Marshfield

54601

Gundersen Lutheran Medical Foundation, La Crosse

55416

CCOP - Metro-Minnesota, Saint Louis Park

55905

Mayo Clinic Cancer Center, Rochester

57709

Rapid City Regional Hospital, Rapid City

58701

Trinity Cancer Care Center, Minot

59101

CCOP - Montana Cancer Consortium, Billings

60005

Northwest Community Hospital, Arlington Heights

60068

Lutheran General Cancer Care Center, Park Ridge

60153

Loyola University Medical Center, Maywood

60426

Ingalls Memorial Hospital, Harvey

60611

Northwestern Memorial Hospital, Chicago

61636

Methodist Medical Center of Illinois, Peoria

62526

CCOP - Central Illinois, Decatur

63108

Mallinckrodt Institute of Radiology, St Louis

64131

CCOP - Kansas City, Kansas City

65203

Ellis Fischel Cancer Center - Columbia, Columbia

65807

Cancer Research for the Ozarks, Springfield

CCOP - Cancer Research for the Ozarks, Springfield

68106

CCOP - Missouri Valley Cancer Consortium, Omaha

68114

Methodist Cancer Center - Omaha, Omaha

70112

MBCCOP - LSU Health Sciences Center, New Orleans

70121

CCOP - Ochsner, New Orleans

70809

Mary Bird Perkins Cancer Center, Baton Rouge

73101

St. Anthony Hospital, Oklahoma City

73104

University of Oklahoma Health Sciences Center, Oklahoma City

74104

St. John Health System, Tulsa

74136

CCOP - Oklahoma, Tulsa

77504

Bayshore Medical Center, Pasadena

79106

Harrington Cancer Center, Amarillo

80010

University of Colorado Cancer Center, Denver

80909

Memorial Hospital Cancer Center, Colorado Springs

84132

University of Utah Health Sciences Center, Salt Lake City

84143

Latter Day Saints Hospital, Salt Lake City

84770

Dixie Regional Medical Center, St. George

85013

Foundation for Cancer Research and Education, Phoenix

87109

Radiation Oncology Associates of Albuquerque, Albuquerque

89106

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas

90822

Veterans Affairs Medical Center - Long Beach, Long Beach

91105

Huntington Cancer Center, Pasadena

91767

Cancer Care Center, Pomona

92101

Radiation Medical Group, Inc., San Diego

92354

Loma Linda University Medical Center, Loma Linda

93720

Saint Agnes Cancer Center, Fresno

94535

David Grant Medical Center, Travis Air Force Base

94904

Sutter Health West Cancer Research Group, Greenbrae

95128

O'Connor Hospital, San Jose

95403

CCOP - Santa Rosa Memorial Hospital, Santa Rosa

95816

Radiation Oncology Center - Sacramento, Sacramento

96813

MBCCOP - Hawaii, Honolulu

97225

CCOP - Columbia River Program, Portland

98111

Virginia Mason Medical Center, Seattle

98902

Yakima Valley Memorial Hospital, Yakima

35294-3300

University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham

36106-3657

Alabama Oncology, LLC, Montgomery

94524-4110

Mount Diablo Medical Center, Concord

91010-3000

City of Hope Comprehensive Cancer Center, Duarte

93729-5100

California Cancer Center, Fresno

90025-1781

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles

90033-0804

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles

94609-3305

CCOP - Bay Area Tumor Institute, Oakland

94143-0128

UCSF Cancer Center and Cancer Research Institute, San Francisco

81502-1628

Saint Mary's Hospital and Medical Center, Grand Junction

06511

Hospital of St. Raphael, New Haven

32610-0385

University of Florida Health Science Center, Gainesville

32901-3276

Health First Holmes Regional Medical Center, Melbourne

33256-2110

Baptist Hospital of Miami, Miami

32405-4587

Gulf Coast Cancer Treatment Center, Panama City

33612-9497

H. Lee Moffitt Cancer Center and Research Institute, Tampa

30342-1701

CCOP - Atlanta Regional, Atlanta

46206-1367

Clarian Health Partners Inc., Indianapolis

47303-3499

Ball Memorial Hospital, Muncie

40536-0084

Albert B. Chandler Medical Center, University of Kentucky, Lexington

70112-2699

Tulane University School of Medicine, New Orleans

04102

Maine Medical Center, Portland

21215-1290

Harbor Hospital Center, Baltimore

21231-2410

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

02114

Massachusetts General Hospital Cancer Center, Boston

02115

Dana-Farber Cancer Institute, Boston

02601

Cape Cod Hospital, Hyannis

02130

Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain

48109-0752

University of Michigan Comprehensive Cancer Center, Ann Arbor

48201-1379

Barbara Ann Karmanos Cancer Institute, Detroit

48532-3685

McLaren Regional Cancer Center, Flint

49007-3731

CCOP - Kalamazoo, Kalamazoo

48073-6769

CCOP - Beaumont, Royal Oak

63110-0250

St. Louis University Health Sciences Center, St Louis

68198-7460

Nebraska Health System, Omaha

03756-0002

Norris Cotton Cancer Center, Lebanon

03103

Elliot Regional Cancer Center, Manchester

01803

Cooper Cancer Institute, Camden

07019

Veterans Affairs Medical Center - East Orange, East Orange

08818

John F. Kennedy Medical Center, Edison

07201

Trinitas Hospital - Jersey Street Campus, Elizabeth

07740-6395

Monmouth Medical Center, Long Branch

08332

South Jersey Regional Cancer Center, Millville

08060

Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County, Mount Holly

38103-2807

Cancer Institute of New Jersey, New Brunswick

07112

Newark Beth Israel Medical Center, Newark

08240

Atlantic City Medical Center, Pomona

07450

Valley Hospital, Ridgewood

08876

Somerset Medical Center, Somerville

08755

Community Medical Center, Toms River

08618

Capital Health System at Mercer, Trenton

08629

St. Francis Medical Center, Trenton

07059

Associated Radiologists, P.A., Warren Township

14263-0001

Roswell Park Cancer Institute, Buffalo

27599-7295

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill

27858-4354

East Carolina University School of Medicine, Greenville

27104-4241

CCOP - Southeast Cancer Control Consortium, Winston-Salem

27157-1082

Comprehensive Cancer Center at Wake Forest University, Winston-Salem

45267-0502

Barrett Cancer Center, Cincinnati

44106-5065

Ireland Cancer Center, Cleveland

43210-1240

Arthur G. James Cancer Hospital - Ohio State University, Columbus

17822-2001

Geisinger Medical Center, Danville

17033-0850

Milton S. Hershey Medical Center, Hershey

19104-4283

University of Pennsylvania Cancer Center, Philadelphia

19107-5541

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia

19141-3098

Albert Einstein Cancer Center, Philadelphia

15213-3489

University of Pittsburgh Cancer Institute, Pittsburgh

19612-6052

Reading Hospital and Medical Center, Reading

02908-4735

Roger Williams Medical Center/BUSM, Providence

38301-3956

Jackson-Madison County General Hospital, Jackson

37232-5671

Vanderbilt-Ingram Cancer Center, Nashville

77555-0209

University of Texas Medical Branch, Galveston

77030-4009

University of Texas - MD Anderson Cancer Center, Houston

78236-5300

Wilford Hall Medical Center, Lackland Air Force Base

79410-1894

Joe Arrington Cancer Research and Treatment Center, Lubbock

05201

Green Mountain Oncology Group, Bennington

05401

Vermont Cancer Center, Burlington

23708-2197

Naval Medical Center, Portsmouth, Portsmouth

23298-0037

Massey Cancer Center, Richmond

99210-0248

Deaconess Medical Center, Spokane

54307-3508

St. Vincent Hospital, Green Bay

T2N 4N2

Tom Baker Cancer Center - Calgary, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

E2L 4L2

Saint John Regional Hospital, Saint John

A1B 3V6

Newfoundland Cancer Treatment and Research Foundation, St. John's

B3H 1V7

Nova Scotia Cancer Centre, Halifax

P3E 5J1

Northeastern Ontario Regional Cancer Centre, Sudbury, Greater Sudbury

L8V 5C2

Cancer Care Ontario-Hamilton Regional Cancer Centre, Hamilton

K7L 5P9

Kingston Regional Cancer Centre, Kingston

N6A 4L6

Cancer Care Ontario-London Regional Cancer Centre, London

K1H 1C4

Ottawa Regional Cancer Centre, Ottawa

P7A 7T1

Northwestern Ontario Regional Cancer Centre, Thunder Bay, Thunder Bay

M4N 3M5

Toronto Sunnybrook Regional Cancer Centre, Toronto

M5G 2M9

Princess Margaret Hospital, Toronto

J1H 5N4

CHUS-Hopital Fleurimont, Fleurimont

H2L 4MI

Centre Hospitalier de l'Universite de Montreal, Montreal

H2W 1S6

McGill University, Montreal

G1R 2J6

Centre Hospitalier Universitaire de Quebec, Québec

S4T 7T1

Allan Blair Cancer Centre, Regina

S7N 4H4

Saskatoon Cancer Centre, Saskatoon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

SWOG Cancer Research Network

NETWORK

collaborator

NRG Oncology

OTHER

lead

Radiation Therapy Oncology Group

NETWORK