Summary

The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study.

Age: 18 Years and older

Gender: Male

Start Date: 10/20/2020

Primary Completion Date (Estimated): 06/26/2028

Study Completion Date (Estimated): 06/26/2028

Accepts Healthy Volunteers: No

Trial Purpose and Description

Eligibility Criteria

Age: 18 Years and older

Gender: Male

Accepts Healthy Volunteers: No

Inclusion criteria:

* 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.

* 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.

* Participants who have not met any treatment discontinuation criteria in the feeder study protocol.

* Willingness to continue practicing acceptable methods of birth control during the study.

Exclusion criteria:

* Participant is unable to comply with the requirements of the study.

* Negative benefit/ risk ratio as determined by the investigator.

* Meet any criteria for treatment discontinuation of the feeder study the participant is coming from.