Study to Continue Darolutamide Treatment for Patients from Previous Bayer Studies

Sponsor: Bayer

Sponsor score: 60

ClinicalTrials ID:NCT04464226

This study allows patients who were part of earlier Bayer-supported darolutamide studies to continue their treatment if their doctor believes it is beneficial. Patients will keep taking the same dose and visit their study centers as before.

Patient Parameters

Program Overview

The purpose of this study is to allow patients who were part of a previous Bayer-supported study with darolutamide to continue their treatment if their doctor thinks it is helpful. Patients will continue taking darolutamide at the same dose and will visit their study centers for check-ups as often as they did in the previous study.

Eligibility Criteria

Inclusion Criteria

  • Able to give informed consent and agree to follow the study's requirements.
  • Currently participating in a Bayer-sponsored darolutamide study and benefiting from the treatment.
  • Have not met any conditions that would stop treatment in the previous study.
  • Willing to continue using acceptable birth control methods during the study.

Exclusion Criteria

  • Unable to follow the study's requirements.
  • Doctor determines that the risks outweigh the benefits.
  • Meet any conditions that would stop treatment in the previous study.

Locations

FACILITYZIPCITYSTATE
Urology Centers of Alabama, PC35209HomewoodAlabama
Ironwood Physicians P.C. DBA Ironwood Cancer & Res. Ctr.85224ChandlerArizona
City of Hope National Medical Center91010DuarteCalifornia
San Diego Clinical Trials91942La MesaCalifornia
Tower Urology, Inc90048Los AngelesCalifornia
VA Greater Los Angeles Healthcare System90073-1003Los AngelesCalifornia
Stanford Health Care94305StanfordCalifornia
TOI Clinical Research90603WhittierCalifornia
VA Eastern Colorado Health Care System80045AuroraColorado
The Urology Center Of Colorado80211DenverColorado

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