hormone-sensitive Prostate cancer
Conditions
Interventions
Darolutamide
Twice daily 600 mg (2 x 300 mg tablets), total daily dose 1200 mg
Orally taken with food
In addition to standard of care.
Sponsors
Bayer
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol 2. Participants enrolled in any Bayer-sponsored darolutamide feeder study at the time of study closure or primary completion, who are currently receiving darolutamide and are experiencing clinical benefit from treatment. 3. Participants who have not met any treatment discontinuation criteria outlined in the feeder study protocol. 4. Willingness to continue practicing acceptable methods of birth control during the study.
Exclusion criteria
Exclusion criteria: 1. Participant is unable to comply with the requirements of the study. 2. Negative benefit/ risk ratio as determined by the investigator. 3. Meet any criteria for treatment discontinuation of the feeder study the participant is coming from.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Incidence of Treatment-emergent adverse events (TEAEs) - Incidence of Treatment-emergent serious adverse events (TESAEs) - Incidence of drug-related TEAEs and TESAEs | — |
Secondary
| Measure | Time frame |
|---|---|
| - Frequency of dose modifications | — |
Countries
Netherlands
Outcome results
None listed