A Study of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer (ODENZA)
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|ClinicalTrials.gov Identifier: NCT03314324|
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : February 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Castrate-resistant Prostate (CRPC) Cancer||Drug: ODM-201 Drug: Enzalutamide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Prospective, randomized, open-label, multicenter, cross-over phase II trial|
|Masking:||None (Open Label)|
|Official Title:||A Study of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer|
|Actual Study Start Date :||November 29, 2017|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
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.
|Active Comparator: 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).
- Patient preference [ Time Frame: up to 24 months ]Patient preference (assessed by a single question) between ODM-201 and enzalutamide after completion of the second period of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314324
|Contact: Karim FIZAZI, MD, PhD||0142114317 ext +email@example.com|
|Contact: Geraldine MARTINEAU, MD||0142115607 ext +firstname.lastname@example.org|
|Villejuif, Val De Marne, France, 94805|
|Contact: Karim FIZAZI, MD 0142114317 ext +33 email@example.com|
|Contact: Geraldine MARTINEAU, MD 0142115607 ext +33 firstname.lastname@example.org|
|Principal Investigator: Karim FIZAZI, MD|
|Study Chair:||Karim FIZAZI, MD||Gustave ROUSSY|