NCT03314324

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess patient preference between ODM-201 and enzalutamide by patient preference questionnaire

Conditions

• Metastatic Castrate-resistant Prostate (CRPC) Cancer

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2017-11-29
• Primary completion: 2022-01-31
• Completion: 2024-09-25
• First posted: 2017-10-19
• Last updated: 2025-04-17

Locations

1 site across 1 country: France