23
Participants
Start Date
June 30, 2020
Primary Completion Date
March 7, 2022
Study Completion Date
March 7, 2022
Enzalutamide during Lead-in Period
Participants will receive 12 weeks open-label lead-in ARB (enzalutamide) that will continue after double-blind randomization to radium-223 or placebo.
Lead-in Enzalutamide followed by Radium-223/Enzalutamide
After a 12-week lead-in period of open-label enzalutamide, participants will be randomized to double-blind radium-223 or placebo. Participants will continue on their randomized, open-label enzalutamide.
Lead-in Enzalutamide followed by Placebo/Enzalutamide
After a 12-week lead-in period of open-label enzalutamide, participants will be randomized to double-blind radium-223 or placebo. Participants will continue on their randomized, open-label enzalutamide.
Darolutamide during Lead-in Period
Participants will receive 12 weeks open-label lead-in darolutamide that will continue after double-blind randomization to radium-223 or placebo.
Lead-in Darolutamide followed by Radium-223/Darolutamide
After a 12-week lead-in period of open-label darolutamide, participants will be randomized to double-blind radium-223 or placebo. Participants will continue on their randomized, open-label darolutamide.
Lead-in Darolutamide followed by Placebo/Darolutamide
After a 12-week lead-in period of open-label darolutamide, participants will be randomized to double-blind radium-223 or placebo. Participants will continue on their randomized, open-label darolutamide.
Research Site, Myrtle Beach
Collaborators (2)
Bayer
INDUSTRY
Carolina Urologic Research Center
OTHER
Tulane University
OTHER
Barbara Ann Karmanos Cancer Institute
OTHER
MANA RBM
OTHER