250
Participants
Start Date
November 29, 2017
Primary Completion Date
January 31, 2022
Study Completion Date
September 25, 2024
ODM-201
ODM-201: 600 mg (2 x 300 mg tablets) twice daily with food equivalent to a total daily dose of 1200 mg. ODM-201 should be taken at similar times day, approximately 12 hours between doses.
Enzalutamide
Enzalutamide: 160 mg/day (4 x 40 mg tablets) taken once a day preferably with food, preferably in the evening (Enzalutamide can generally be given with or without food, but in the present trial, it is preferable that it is given with food, to be consistent with ODM-201 intake).
Gustave Roussy, Villejuif
Gustave Roussy, Cancer Campus, Grand Paris
OTHER