A Study of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

November 29, 2017

Primary Completion Date

January 31, 2022

Study Completion Date

September 25, 2024

Conditions
Metastatic Castrate-resistant Prostate (CRPC) Cancer
Interventions
DRUG

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.

DRUG

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).

Trial Locations (1)

94805

Gustave Roussy, Villejuif

All Listed Sponsors
lead

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

NCT03314324 - A Study of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer | Biotech Hunter | Biotech Hunter