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Trial 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.

Acronym:

ACTRN/NCT /ethics:

NCT04464226

Scientific title:

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

Sponsor / Cooperative group:

Bayer

Trial & Patient Characteristics

Cancer TypeProstate
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexMale
Tumour Stream -
Cancer StageAll stages
Anticipated Start Date2020-10-30
Anticipated End Date2024-10-18

Participating Hospitals

HospitalAshford Cancer Centre Research
Clinical Trial CoordinatorSue Yeend
Emailsyeend@adelaidecancercentre.com.au
Phone08 8292 2240
Principal InvestigatorDr Francis Parnis
Recruitment StatusRecruiting