Open Label Phase Two Trial of Radium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in Symptomatic Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Bone Metastasis

PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Prostate Cancer
Interventions
DRUG

Concurrent use of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone

Radium Ra 223 dichloride - A targeted alpha particle-emitting pharmaceutical (a radiopharmaceutical drug) is a ready-to-use solution for intravenous injection containing the drug substance radium dichloride. The active moiety is the alpha particle emitting nuclide Ra-223, present as a divalent cation (223Ra2+) and Abiraterone Acetate - A CYP17 inhibitor, indicated in combination with prednisone for the treatment of subjects with metastatic castration-resistant prostate cancer. Administration of Abiraterone Acetate may result in mineralocorticoid-related adverse events (AEs), due to CYP17 inhibition. Therefore, Abiraterone Acetate is administered in combination with Prednisone to reduce the frequency of these AEs.

Trial Locations (5)

13210

Associated Medical Professionals, Syracuse

21204

Chesapeake urology Research Associates, Towson

29572

Carolina Urologic Research Center, Myrtle Beach

68130

Urology Cancer Center and GU Research Network, Omaha

97477

Oregon Urology Institute, Springfield

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Carolina Research Professionals, LLC

OTHER