Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy

PHASE2CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

December 31, 2013

Study Completion Date

May 14, 2018

Conditions
Prostate Cancer
Interventions
DRUG

bicalutamide

50 mg (one tablet) daily orally for 6 months, starting within 6 months after registration

DRUG

docetaxel

75 mg/m2 IV over 1 hour on day 1 of each cycle q21 days for 6 cycles, starting 3-6 weeks after completion of radiation therapy

DRUG

flutamide

250 mg (two 125-mg capsules) three times daily (total 750 mg) orally for 6 months, starting within 6 months after registration

DRUG

LHRH agonist

LHRH agonist (such as leuprolide, goserelin, buserelin, or triptorelin) for 6 months, starting within 6 weeks after registration

RADIATION

3-dimensional conformal radiation therapy

RADIATION

radiation therapy

66.6 Gy (1.8 Gy per fraction, 5 days per week) to the prostate bed (IMRT or 3DCRT), starting 8 weeks after start of hormones

Trial Locations (70)

18015

St. Luke's Cancer Network at St. Luke's Hospital, Bethlehem

18925

Fox Chase Cancer Center Buckingham, Furlong

19013

Crozer-Chester Medical Center, Upland

19026

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

19140

Fox Chase Cancer Center CCOP Research Base, Philadelphia

19713

CCOP - Christiana Care Health Services, Newark

21201

Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore

27103

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

27534

Wayne Radiation Oncology, Goldsboro

27607

Cancer Centers of North Carolina - Raleigh, Raleigh

28791

Pardee Memorial Hospital, Hendersonville

28801

Mission Hospitals - Memorial Campus, Asheville

29303

CCOP - Upstate Carolina, Spartanburg

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg

39581

Regional Cancer Center at Singing River Hospital, Pascagoula

40207

Norton Suburban Hospital, Louisville

44203

Barberton Citizens Hospital, Barberton

44460

Cancer Care Center, Incorporated, Salem

44691

Cancer Treatment Center, Wooster

45069

Precision Radiotherapy at University Pointe, West Chester

45267

Charles M. Barrett Cancer Center at University Hospital, Cincinnati

48202

Josephine Ford Cancer Center at Henry Ford Hospital, Detroit

53051

Community Memorial Hospital Cancer Care Center, Menomonee Falls

53226

Medical College of Wisconsin Cancer Center, Milwaukee

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

56303

CentraCare Clinic - River Campus, Saint Cloud

57701

Rapid City Regional Hospital, Rapid City

61801

CCOP - Carle Cancer Center, Urbana

62702

Cancer Institute at St. John's Hospital, Springfield

63110

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

63703

Cancer Institute of Cape Girardeau, LLC, Cape Girardeau

70112

MBCCOP - LSU Health Sciences Center, New Orleans

70121

CCOP - Ochsner, New Orleans

70809

Mary Bird Perkins Cancer Center - Baton Rouge, Baton Rouge

73104

Oklahoma University Cancer Institute, Oklahoma City

73112

Integris Oncology Services, Oklahoma City

80211

Urology Center of Colorado, Denver

80528

Poudre Valley Radiation Oncology, Fort Collins

84157

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

85013

Arizona Oncology Services Foundation, Phoenix

89135

Nevada Cancer Institute, Las Vegas

94115

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco

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

95819

Mercy General Hospital, Sacramento

98101

CCOP - Virginia Mason Research Center, Seattle

71315-3198

Tulane Cancer Center Office of Clinical Research, Alexandria

02114

Massachusetts General Hospital, Boston

02721

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

55422-2900

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

08053

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

07112

Newark Beth Israel Medical Center, Newark

08540-3298

University Medical Center at Princeton, Princeton

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

19111-2497

Fox Chase Cancer Center - Philadelphia, Philadelphia

H2W 1S6

McGill Cancer Centre at McGill University, Montreal

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

NRG Oncology

OTHER

lead

Radiation Therapy Oncology Group

NETWORK