68
Participants
Start Date
March 7, 2014
Primary Completion Date
July 15, 2016
Study Completion Date
June 26, 2018
Radium-223 dichloride (Xofigo, BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg (55 kBq/kg after implementation of NIST \[National Institute of Standards and Technology\] update) every 4 weeks x 6 doses intravenous slow bolus
Abiraterone acetate
Abiraterone acetate 1000 mg (4 x 250 mg tablets) taken orally once daily for up to two years following last dose of radium-223 dichloride
Prednisone
Prednisone 5 mg capsule taken orally twice daily for up to two years following last dose of radium-223 dichloride
Enzalutamide
Enzalutamide 160 mg (four 40 mg capsules) taken orally once daily for up to two years following last dose of radium-223 dichloride
Syracuse
Newark
Washington D.C.
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Plantation
Indianapolis
Detroit
St Louis
Omaha
New Orleans
Shreveport
Houston
Scottsdale
Tucson
Los Angeles
Springfield
Seattle
New Haven
The Bronx
Lead Sponsor
Bayer
INDUSTRY