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Continuation of darolutamide treatment for previous participants

An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies

Phase 3 Interventional Bayer · NCT04464226

This study is testing if patients who have previously benefited from darolutamide can keep taking it to maintain their health and well-being.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment402 (estimated)
Ages18 Years and up
SexMale
SponsorBayer Industry-sponsored
Locations376 sites (Homewood, Alabama and 375 other locations)
Trial IDNCT04464226 on ClinicalTrials.gov

What this trial studies

This study aims to provide ongoing treatment with darolutamide for patients who have previously participated in studies involving this medication and are deemed to benefit from continued therapy by their doctors. Participants will receive darolutamide at the same dosage as before and will return to study centers for regular check-ups, maintaining the same schedule as in their prior studies. The study is designed to ensure that patients who have shown clinical benefit from darolutamide can continue their treatment without interruption.

Who should consider this trial

Good fit: Ideal candidates are patients who have previously participated in darolutamide studies and are currently experiencing clinical benefits from the treatment.

Not a fit: Patients who have not shown clinical benefit from darolutamide or who meet treatment discontinuation criteria from previous studies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help maintain the therapeutic benefits of darolutamide for patients with cancer who have responded well to the treatment.

How similar studies have performed: Other studies involving darolutamide have shown positive outcomes, indicating that this continuation approach is based on previously successful treatment protocols.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Homewood, Alabama and 375 other locations

+326 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
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Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.