Androgen Deprivation Therapy +/- Radium-223 Dichloride in Metastatic Prostate Cancer With Bone Metastases

PHASE2TerminatedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

September 14, 2017

Study Completion Date

September 14, 2017

Conditions
Prostate CancerBone MetastasesProstate Neoplasms
Interventions
DRUG

LHRH agonist/antagonist

Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle.

DRUG

Bicalutamide

Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle.

RADIATION

Radium-223 dichloride

Radium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight intravenous (IV bolus) every 28 days for 6 injections

Trial Locations (12)

11042

Integrated Medical Professionals, PLLC, Lake Success

46202

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

46219

IU Health Central Indiana Cancer Centers, Indianapolis

48109

University of Michigan Health System, Ann Arbor

48202

Henry Ford Hospital, Detroit

49519

Metro Health Cancer Center, Wyoming

52242

University of Iowa Hopital and Clinics, Iowa City

53295

Clement J. Zablocki VA Medical Center, Milwaukee

61615

Illinois CancerCare, P. C., Peoria

68130

GU Research Network, LLC, Omaha

77555

University of Texas Medical Branch at Galveston, Galveston

85004

University of Arizona Cancer Center at Dignity Health St. Joseph's, Phoenix

Sponsors
All Listed Sponsors
collaborator

Hoosier Cancer Research Network

OTHER

collaborator

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

INDUSTRY

lead

Ajjai Alva, MD

OTHER