Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

239

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

November 1, 2021

Study Completion Date

September 4, 2025

Conditions
Prostate Cancer
Interventions
DRUG

GnRH agonist

LHRH agonists are administered with a variety of techniques. The manufacturer's instructions should be followed. Begins within 6 weeks after registration (if not started prior) at same time as anti-androgen and TAK-700 (if applicable).

DRUG

Anti-androgen

Starts at same time as GnRH agonist, ends at end of radiation therapy. Either flutamide (orally 250 mg three times a day) or bicalutamide (orally 50 mg once a day).

DRUG

TAK-700

300 mg twice daily (BID) (600 mg per day) orally, continuously for 2 years starting with ADT.

RADIATION

Radiation therapy

Starts 8-10 weeks after initiation of ADT. Initially 45 Gy (1.8 Gy / fraction) to prostate and pelvic lymph nodes delivered with 3DCRT/IMRT, then a boost using intensity-modulated radiation therapy (IMRT), low dose rate (LDR) brachytherapy, or high dose rate (HDR) brachytherapy.

Trial Locations (172)

16505

The Regional Cancer Center, Erie

17325

Adams Cancer Center, Gettysburg

17331

Cherry Tree Cancer Center, Hanover

17405

WellSpan Health-York Hospital, York

19026

Delaware County Memorial Hospital, Drexel Hill

19096

Lankenau Hospital, Wynnewood

19107

Thomas Jefferson University Hospital, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

19140

Temple University Hospital, Philadelphia

19301

Paoli Memorial Hospital, Paoli

19611

Reading Hospital, West Reading

19713

Helen F Graham Cancer Center, Newark

19718

Christiana Care Health System-Christiana Hospital, Newark

21229

Saint Agnes Hospital, Baltimore

21801

Peninsula Regional Medical Center, Salisbury

23454

Sentara Virginia Beach General Hospital, Virginia Beach

23507

Sentara Hospitals, Norfolk

23666

Sentara Cancer Institute at Sentara CarePlex Hospital, Hampton

24014

Oncology and Hematology Associates of Southwest Virginia, Roanoke

29169

Lexington Medical Center, West Columbia

29303

Spartanburg Regional Medical Center, Spartanburg

29651

Gibbs Cancer Center-Pelham, Greer

30033

Atlanta VA Medical Center, Decatur

30303

Grady Health System, Atlanta

30309

Piedmont Hospital, Atlanta

30322

Emory University/Winship Cancer Institute, Atlanta

31405

Saint Joseph's-Candler Health System, Savannah

32803

Florida Hospital, Orlando

33136

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami

33442

University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach

35243

The Kirklin Clinic at Acton Road, Birmingham

35294

University of Alabama at Birmingham, Birmingham

40536

University of Kentucky, Lexington

43210

Ohio State University Medical Center, Columbus

43560

Flower Hospital, Sylvania

44024

Geaugra Hospital, Chardon

44035

Mercy Cancer Center-Elyria, Elyria

44060

Lake University Ireland Cancer Center, Mentor

44106

Case Western Reserve University, Cleveland

44122

UHHS-Chagrin Highlands Medical Center, Orange

44130

Southwest General Health Center Ireland Cancer Center, Middleburg Heights

44145

UHHS-Westlake Medical Center, Westlake

44195

Cleveland Clinic Foundation, Cleveland

44203

Summa Barberton Hospital, Barberton

44256

Summa Health Center at Lake Medina, Medina

44266

Robinson Radiation Oncology, Ravenna

44304

Summa Akron City Hospital/Cooper Cancer Center, Akron

44307

Akron General Medical Center, Akron

44870

Ireland Cancer Center at Firelands Regional Medical Center, Sandusky

45267

University of Cincinnati, Cincinnati

46804

Radiation Oncology Associates PC, Fort Wayne

46805

Parkview Hospital Randallia, Fort Wayne

48073

William Beaumont Hospital-Royal Oak, Royal Oak

48098

William Beaumont Hospital - Troy, Troy

48109

University of Michigan, Ann Arbor

48446

Great Lakes Cancer Institute-Lapeer Campus, Lapeer

48532

McLaren-Flint, Flint

48867

McLaren Cancer Institute-Owosso, Owosso

49007

West Michigan Cancer Center, Kalamazoo

49221

Bixby Medical Center, Adrian

49770

Northern Michigan Regional Hospital, Petoskey

52242

University of Iowa Hospitals and Clinics, Iowa City

53097

Columbia Saint Mary's Hospital - Ozaukee, Mequon

53211

Columbia Saint Mary's Water Tower Medical Commons, Milwaukee

53226

Froedtert and the Medical College of Wisconsin, Milwaukee

53295

Clement J. Zablocki VA Medical Center, Milwaukee

53405

Wheaton Franciscan Cancer Care - All Saints, Racine

54143

Bay Area Medical Center, Marinette

54301

Saint Vincent Hospital, Green Bay

54303

Saint Mary's Hospital, Green Bay

54601

Gundersen Lutheran, La Crosse

54911

Appleton Medical Center, Appleton

55101

Regions Hospital, Saint Paul

55805

Saint Luke's Hospital of Duluth, Duluth

56601

Sanford Clinic North-Bemidgi, Bemidji

57701

Rapid City Regional Hospital, Rapid City

58122

Sanford Medical Center-Fargo, Fargo

58501

Sanford Bismarck Medical Center, Bismarck

59405

Benefis Healthcare- Sletten Cancer Institute, Great Falls

60141

Hines Veterans Administration Hospital, Hines

60153

Loyola University Medical Center, Maywood

60640

Weiss Memorial Hospital, Chicago

61637

OSF Saint Francis Medical Center, Peoria

62526

Decatur Memorial Hospital, Decatur

63110

Washington University School of Medicine, St Louis

63129

Siteman Cancer Center-South County, St Louis

63131

Missouri Baptist Medical Center, St Louis

63141

Barnes-Jewish West County Hospital, St Louis

Saint John's Mercy Medical Center, St Louis

63376

Siteman Cancer Center - Saint Peters, City of Saint Peters

63703

Southeast Cancer Center, Cape Girardeau

64064

Kansas City Cancer Center-Lee's Summit, Lee's Summit

64131

Kansas City Cancer Center - South, Kansas City

64154

Kansas City Cancer Centers - North, Kansas City

65804

Mercy Hospital Springfield, Springfield

66160

University of Kansas Medical Center, Kansas City

66210

Kansas City Cancer Centers-Southwest, Overland Park

68114

Nebraska Methodist Hospital, Omaha

68198

The Nebraska Medical Center, Omaha

70115

Touro Infirmary, New Orleans

70121

Ochsner Medical Center Jefferson, New Orleans

70809

Mary Bird Perkins Cancer Center, Baton Rouge

73104

University of Oklahoma Health Sciences Center, Oklahoma City

74136

Natalie Warren Bryant Cancer Center at Saint Francis, Tulsa

75090

Texas Cancer Center-Sherman, Sherman

75390

University of Texas Southwestern Medical Center, Dallas

76022

Texas Oncology PA - Bedford, Bedford

76104

The Klabzuba Cancer Center, Fort Worth

77024

Memorial Hermann Memorial City Medical Center, Houston

77030

M D Anderson Cancer Center, Houston

77479

Texas Oncology Cancer Center Sugar Land, Sugar Land

77573

UTMB Cancer Center at Victory Lakes, League City

80045

University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora

80528

Poudre Valley Radiation Oncology, Fort Collins

83642

Idaho Urologic Institute PA, Meridian

83706

Saint Alphonsus Regional Medical Center, Boise

84106

Utah Cancer Specialists-Salt Lake City, Salt Lake City

84157

Intermountain Medical Center, Murray

84770

Dixie Medical Center Regional Cancer Center, St. George

85027

Arizona Oncology-Deer Valley Center, Phoenix

85260

Arizona Oncology Services Foundation, Scottsdale

90033

Los Angeles County-USC Medical Center, Los Angeles

University of Southern California/Norris Cancer Center, Los Angeles

90048

Cedars-Sinai Medical Center, Los Angeles

90822

Veterans Administration Long Beach Medical Center, Long Beach

91767

Pomona Valley Hospital Medical Center, Pomona

92103

University of California At San Diego, San Diego

94080

Kaiser Permanente Cancer Treatment Center, South San Francisco

94115

UCSF-Mount Zion, San Francisco

94305

Stanford University Hospitals and Clinics, Stanford

94589

Sutter Solano Medical Center, Vallejo

94928

Rohnert Park Cancer Center, Rohnert Park

95051

Kaiser Permanente Medical Center - Santa Clara, Santa Clara

95603

Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn

95608

Mercy San Juan Medical Center, Carmichael

95661

Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville

95682

Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park

95687

Sutter Cancer Centers Radiation Oncology Services-Vacaville, Vacaville

95816

Sutter General Hospital, Sacramento

96813

Queen's Medical Center, Honolulu

97504

Rogue Valley Medical Center, Medford

98003

Saint Francis Hospital, Federal Way

98101

Virginia Mason CCOP, Seattle

06102

Hartford Hospital, Hartford

06050

The Hospital of Central Connecticut, New Britain

06360

William Backus Hospital, Norwich

04074

Maine Medical Center- Scarborough Campus, Scarborough

02114

Massachusetts General Hospital Cancer Center, Boston

02115

Brigham and Women's Hospital, Boston

Dana-Farber Cancer Institute, Boston

02215

Beth Israel Deaconess Medical Center, Boston

02721

Saint Anne's Hospital, Fall River

01757

Dana-Farber/Brigham and Women's Cancer Center at Milford Regional, Milford

01960

North Shore Medical Center Cancer Center, Peabody

02190

Dana-Farber/Brigham and Women's Cancer Center at South Shore, South Weymouth

48106-0995

Saint Joseph Mercy Hospital, Ann Arbor

03301

Concord Hospital, Concord

03833

Exeter Hospital, Exeter

03756

Dartmouth Hitchcock Medical Center, Lebanon

03103

Elliot Hospital, Manchester

08103

Cooper Hospital University Medical Center, Camden

08901

Saint Peter's University Hospital, New Brunswick

08043

MD Anderson Cancer Center at Cooper-Voorhees, Voorhees Township

77555-0565

University of Texas Medical Branch at Galveston, Galveston

54235-1495

Door County Cancer Center, Sturgeon Bay

T2N 4N2

Tom Baker Cancer Centre, Calgary

V1Y 5L3

BCCA-Cancer Centre for the Southern Interior, Kelowna

N6A 4L6

London Regional Cancer Program, London

K1H 1C4

Ottawa Health Research Institute-General Division, Ottawa

H2L 4M1

CHUM - Hopital Notre-Dame, Montreal

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

NRG Oncology

OTHER

lead

Radiation Therapy Oncology Group

NETWORK