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

PHASE3CompletedINTERVENTIONAL
Enrollment

612

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

April 30, 2014

Study Completion Date

May 20, 2022

Conditions
Prostate Cancer
Interventions
DRUG

Dexamethasone

Premedication of dexamethasone prior to docetaxel, per institutional standards.

DRUG

Prednisone

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

DRUG

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.

DRUG

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

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.

DRUG

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.

Trial Locations (254)

12206

New York Oncology Hematology, PC at Albany Regional Cancer Care, Albany

13210

SUNY Upstate Medical University Hospital, Syracuse

Veterans Affairs Medical Center - Syracuse, Syracuse

13326

Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital, Cooperstown

14642

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

15009

UPMC Cancer Center at Beaver Medical Center, Beaver

15025

UPMC Cancer Center at Jefferson Regional Medical Center, Clairton

15065

UPMC Cancer Center - Natrona Heights, Natrona Heights

15108

UPMC - Moon, Moon Township

15132

UPMC Cancer Center at UPMC McKeesport, McKeesport

15213

UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh

UPMC Cancer Center at UPMC Presbyterian, Pittsburgh

15215

UPMC Cancer Center at UPMC St. Margaret, Pittsburgh

15237

UPMC Cancer Center at UPMC Passavant, Pittsburgh

15243

UPMC Cancer Center - Upper St. Clair, Pittsburgh

15301

Washington Hospital Cancer Center, Washington

15401

UPMC Cancer Center - Uniontown, Uniontown

15601

UPMC Cancer Center - Arnold Palmer Pavilion, Greensburg

15901

UPMC Cancer Center at the John P. Murtha Pavilion, Johnstown

16105

Jameson Memorial Hospital - North Campus, New Castle

16214

Cancer Center at Clarion Hospital, Clarion

16346

UPMC Cancer Center at UPMC Northwest, Seneca

17405

York Cancer Center at Apple Hill Medical Center, York

18512

Northeast Radiation Oncology Center, Dunmore

18840

Guthrie Cancer Center at Guthrie Clinic Sayre, Sayre

18960

Grand View Hospital, Sellersville

19001

Rosenfeld Cancer Center at Abington Memorial Hospital, Abington

19023

Mercy Fitzgerald Hospital, Darby

19026

Delaware County Regional Cancer Center at Delaware County Memorial Hospital, Drexel Hill

19096

CCOP - Main Line Health, Wynnewood

Lankenau Cancer Center at Lankenau Hospital, Wynnewood

19713

CCOP - Christiana Care Health Services, Newark

20814

Suburban Hospital, Bethesda

21229

St. Agnes Hospital Cancer Center, Baltimore

21401

DeCesaris Cancer Institute at Anne Arundel Medical Center, Annapolis

23249

Veterans Affairs Medical Center - Richmond, Richmond

25304

West Virginia University Health Sciences Center - Charleston, Charleston

27103

Forsyth Regional Cancer Center at Forsyth Medical Center, Winston-Salem

27261

High Point Regional Hospital, High Point

27710

Duke Comprehensive Cancer Center, Durham

27834

Leo W. Jenkins Cancer Center at ECU Medical School, Greenville

28053

CaroMont Cancer Center at Gaston Memorial Hospital, Gastonia

28401

New Hanover Radiation Oncology, PA, Wilmington

29303

CCOP - Upstate Carolina, Spartanburg

29425

Hollings Cancer Center at Medical University of South Carolina, Charleston

29615

CCOP - Greenville, Greenville

30303

Georgia Cancer Center for Excellence at Grady Memorial Hospital, Atlanta

30322

Winship Cancer Institute of Emory University, Atlanta

30501

Northeast Georgia Medical Center, Gainesville

31904

John B. Amos Cancer Center, Columbus

32401

Bay Medical, Panama City

35294

UAB Comprehensive Cancer Center, Birmingham

37916

Thompson Cancer Survival Center, Knoxville

39581

Regional Cancer Center at Singing River Hospital, Pascagoula

40207

Norton Suburban Hospital, Louisville

43560

Flower Hospital Cancer Center, Sylvania

43608

St. Vincent Mercy Medical Center, Toledo

43614

Medical University of Ohio Cancer Center, Toledo

43616

St. Charles Mercy Hospital, Oregon

43617

CCOP - Toledo Community Hospital, Toledo

44111

Cleveland Clinic Cancer Center at Fairview Hospital, Cleveland

44124

Hillcrest Cancer Center at Hillcrest Hospital, Mayfield Heights

44131

Cleveland Clinic Cancer Center, Independence

44195

Cleveland Clinic Taussig Cancer Center, Cleveland

44203

Barberton Citizens Hospital, Barberton

44460

Cancer Care Center, Incorporated, Salem

44691

Cancer Treatment Center, Wooster

Cleveland Clinic - Wooster, Wooster

45267

Charles M. Barrett Cancer Center at University Hospital, Cincinnati

45385

Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia

45405

Grandview Hospital, Dayton

45406

Good Samaritan Hospital, Dayton

45409

David L. Rike Cancer Center at Miami Valley Hospital, Dayton

45415

Samaritan North Cancer Care Center, Dayton

45428

Veterans Affairs Medical Center - Dayton, Dayton

45429

Charles F. Kettering Memorial Hospital, Kettering

45804

Lima Memorial Hospital, Lima

46016

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

46202

Veterans Affairs Medical Center - Indianapolis, Indianapolis

46219

Central Indiana Cancer Centers - East, Indianapolis

46804

Radiation Oncology Associates Southwest, Fort Wayne

46805

Parkview Regional Cancer Center at Parkview Health, Fort Wayne

48073

William Beaumont Hospital - Royal Oak Campus, Royal Oak

48202

Josephine Ford Cancer Center at Henry Ford Hospital, Detroit

48910

Breslin Cancer Center at Ingham Regional Medical Center, Lansing

49221

Hickman Cancer Center at Bixby Medical Center, Adrian

50010

McFarland Clinic, PC, Ames

53051

Community Memorial Hospital Cancer Care Center, Menomonee Falls

53081

Vince Lombardi Cancer Clinic - Sheboygan, Sheboygan

53097

Columbia Saint Mary's Hospital - Ozaukee, Mequon

53211

Columbia-Saint Mary's Cancer Care Center, Milwaukee

53226

Medical College of Wisconsin Cancer Center, Milwaukee

53295

Veterans Affairs Medical Center - Milwaukee, Milwaukee

54143

Bay Area Cancer Care Center at Bay Area Medical Center, Marinette

54401

University of Wisconcin Cancer Center at Aspirus Wausau Hospital, Wausau

54601

Gundersen Lutheran Center for Cancer and Blood, La Crosse

54911

Theda Care Cancer Institute, Appleton

55102

United Hospital, Saint Paul

55109

Minnesota Oncology Hematology, PA - Maplewood, Maplewood

55337

Fairview Ridges Hospital, Burnsville

55387

Ridgeview Medical Center, Waconia

55407

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis

55416

CCOP - Metro-Minnesota, Saint Louis Park

55432

Mercy and Unity Cancer Center at Unity Hospital, Fridley

55433

Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids

55435

Fairview Southdale Hospital, Edina

55805

St. Luke's Hospital Cancer Care Center, Duluth

59101

CCOP - Montana Cancer Consortium, Billings

59405

Great Falls Clinic - Main Facility, Great Falls

Sletten Cancer Institute at Benefis Healthcare, Great Falls

60005

Northwest Community Hospital, Arlington Heights

60126

Elmhurst Memorial Hospital, Elmhurst

61108

Center for Cancer Care at OSF Saint Anthony Medical Center, Rockford

62526

Decatur Memorial Hospital Cancer Care Institute, Decatur

62702

Cancer Institute at St. John's Hospital, Springfield

63110

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, St Louis

63141

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

63703

Cancer Institute of Cape Girardeau, LLC, Cape Girardeau

64131

Kansas City Cancer Centers - South, Kansas City

64154

Kansas City Cancer Centers - North, Kansas City

64804

St. John's Regional Medical Center, Joplin

65804

St. John's Regional Health Center, Springfield

65807

Hulston Cancer Center at Cox Medical Center South, Springfield

66210

Kansas City Cancer Centers - Southwest, Overland Park

68106

CCOP - Missouri Valley Cancer Consortium, Omaha

68114

Methodist Estabrook Cancer Center, Omaha

68122

Immanuel Medical Center, Omaha

68124

Alegant Health Cancer Center at Bergan Mercy Medical Center, Omaha

70121

CCOP - Ochsner, New Orleans

73104

Oklahoma University Cancer Institute, Oklahoma City

74136

Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa

75090

Texas Oncology, PA at Texas Cancer Center - Sherman, Sherman

75230

Medical City Dallas Hospital, Dallas

75237

Texas Oncology, PA at Texas Cancer Center Dallas Southwest, Dallas

76022

Texas Oncology, PA at Harris Center HEB, Bedford

76104

Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital, Fort Worth

77479

Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land, Sugar Land

77802

St. Joseph Regional Cancer Center, Bryan

80012

Rocky Mountain Cancer Centers - Aurora, Aurora

80033

Exempla Lutheran Medical Center, Wheat Ridge

80045

University of Colorado Cancer Center at UC Health Sciences Center, Aurora

80110

Swedish Medical Center, Englewood

80528

Poudre Valley Radiation Oncology, Fort Collins

80539

McKee Medical Center, Loveland

80631

North Colorado Medical Center, Greeley

81502

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

83706

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center, Boise

84112

Huntsman Cancer Institute at University of Utah, Salt Lake City

84157

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray

84403

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

84770

Dixie Regional Medical Center - East Campus, St. George

85013

Arizona Oncology Services Foundation, Phoenix

85704

Arizona Oncology - Tucson, Tucson

87102

Lovelace Medical Center - Downtown, Albuquerque

87109

New Mexico Cancer Center, Albuquerque

Radiation Oncology Associates, PA, Albuquerque

87505

Cancer Institute of New Mexico, Santa Fe

89106

CCOP - Nevada Cancer Research Foundation, Las Vegas

89135

Nevada Cancer Institute, Las Vegas

90509

Torrance Memorial Medical Center, Torrance

91505

Providence Saint Joseph Medical Center - Burbank, Burbank

92270

Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center, Rancho Mirage

94118

California Pacific Medical Center - California Campus, San Francisco

94538

Washington Township Hospital, Fremont

94598

John Muir/Mt. Diablo Comprehensive Cancer Center, Walnut Creek

94609

CCOP - Bay Area Tumor Institute, Oakland

95355

Memorial Medical Center, Modesto

95603

Auburn Radiation Oncology, Auburn

95608

Mercy Cancer Center at Mercy San Juan Medical Center, Carmichael

95661

Radiation Oncology Center - Roseville, Roseville

95682

Radiation Oncology Centers - Cameron Park, Cameron Park

95687

Solano Radiation Oncology Center, Vacaville

95815

Radiological Associates of Sacramento Medical Group, Incorporated, Sacramento

95817

University of California Davis Cancer Center, Sacramento

95819

Mercy General Hospital, Sacramento

95926

Enloe Cancer Center at Enloe Medical Center, Chico

95945

Sierra Nevada Cancer Center at Sierra Nevada Memorial Hospital, Grass Valley

96813

Cancer Research Center of Hawaii, Honolulu

97058

Celilo Cancer Center at Mid-Columbia Medical Center, The Dalles

97401

Willamette Valley Cancer Center - Eugene, Eugene

98405

CCOP - Northwest, Tacoma

98431

Madigan Army Medical Center - Tacoma, Tacoma

99204

Providence Cancer Center at Sacred Heart Medical Center, Spokane

99508

Providence Cancer Center, Anchorage

94524-4110

Cancer Care Center at John Muir Health - Concord Campus, Concord

92093-0658

Rebecca and John Moores UCSD Cancer Center, La Jolla

06606

St. Vincent's Medical Center, Bridgeport

06610

Bridgeport Hospital, Bridgeport

06511

Hospital of Saint Raphael, New Haven

06520-8028

Yale Cancer Center, New Haven

06360

Eastern Connecticut Hematology and Oncology Associates, Norwich

William W. Backus Hospital, Norwich

32610-0232

University of Florida Shands Cancer Center, Gainesville

31403-3089

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

60068-1174

Advocate Lutheran General Cancer Care Center, Park Ridge

62781-0001

Regional Cancer Center at Memorial Medical Center, Springfield

52242-1002

Holden Comprehensive Cancer Center at University of Iowa, Iowa City

66160-7357

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

71315-3198

Tulane Cancer Center Office of Clinical Research, Alexandria

04074

Maine Center for Cancer Medicine and Blood Disorders - Scarborough, Scarborough

02114

Massachusetts General Hospital, Boston

02721

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

02048

Shields Radiation Oncology Center - Mansfield, Mansfield

01960

NSMC Cancer Center - Peabody, Peabody

02169

South Suburban Oncology Center, Quincy

48109-0942

University of Michigan Comprehensive Cancer Center, Ann Arbor

48201-1379

Barbara Ann Karmanos Cancer Institute, Detroit

49007-3731

West Michigan Cancer Center, Kalamazoo

55422-2900

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale

68131-2197

Creighton University Medical Center, Omaha

03301

Dartmouth - Hitchcock Concord, Concord

03820

Seacoast Cancer Center at Wentworth - Douglass Hospital, Dover

03833

Center for Cancer Care at Exeter Hospital, Exeter

03431

Kingsbury Center for Cancer Care at Cheshire Medical Center, Keene

03756-0002

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon

03103

Elliot Regional Cancer Center at Elliot Hospital, Manchester

08103

Cancer Institute of New Jersey at Cooper University Hospital - Camden, Camden

07728

CentraState Medical Center, Freehold

08053

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton

08901

Saint Peter's University Hospital, New Brunswick

08903

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

08043

Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees Township

87131-5636

University of New Mexico Cancer Center, Albuquerque

28232-2861

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte

28233-3549

Presbyterian Cancer Center at Presbyterian Hospital, Charlotte

27157-1096

Wake Forest University Comprehensive Cancer Center, Winston-Salem

44309-2090

Summa Center for Cancer Care at Akron City Hospital, Akron

45005-1066

Middletown Regional Hospital, Franklin

43537-1839

Northwest Ohio Oncology Center, Maumee

45373-1300

UVMC Cancer Care Center at Upper Valley Medical Center, Troy

97239-3098

Knight Cancer Institute at Oregon Health and Science University, Portland

97309-5014

Salem Hospital Regional Cancer Care Services, Salem

17033-0850

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey

19301-1792

Cancer Center of Paoli Memorial Hospital, Paoli

19107-5541

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia

19111-2497

Fox Chase Cancer Center - Philadelphia, Philadelphia

15213-2582

UPMC - Shadyside, Pittsburgh

19612-6052

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center, Reading

77030-4009

M. D. Anderson Cancer Center at University of Texas, Houston

05401

Fletcher Allen Health Care - University Health Center Campus, Burlington

05701

Community Cancer Center at Rutland Regional Medical Center, Rutland

23708-2197

Naval Medical Center - Portsmouth, Portsmouth

23298-0037

Virginia Commonwealth University Massey Cancer Center, Richmond

54301-3526

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

54307-3508

St. Vincent Hospital Regional Cancer Center, Green Bay

T2N 4N2

Tom Baker Cancer Centre - Calgary, Calgary

T6G 1Z2

Cross Cancer Institute at University of Alberta, Edmonton

L8V 5C2

Margaret and Charles Juravinski Cancer Centre, Hamilton

N6A 4L6

London Regional Cancer Program at London Health Sciences Centre, London

K1Y 4K7

Ottawa Hospital Regional Cancer Centre - General Campus, Ottawa

H2L 4M1

Hopital Notre-Dame du CHUM, Montreal

H2W 1S6

McGill Cancer Centre at McGill University, Montreal

G1R 2J6

Centre Hospitalier Universitaire de Quebec, Québec

S4T 7T1

Allan Blair Cancer Centre at Pasqua Hospital, Regina

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

NRG Oncology

OTHER

lead

Radiation Therapy Oncology Group

NETWORK