Status:
NOT_YET_RECRUITING
An Observational Study to Learn More About How Medicines That Block Male Hormones Are Used in People With Prostate Cancer in Australia
Lead Sponsor:
Bayer
Conditions:
Metastatic Hormonesensitive Prostate Cancer (mHSPC)
Eligibility:
MALE
18+ years
Brief Summary
This is a retrospective, observational study looking at real-world prescription data in Australia. The study focuses on adult men with metastatic hormone-sensitive prostate cancer (mHSPC), a type of p...
Eligibility Criteria
Inclusion
- Male patients with evidence of mHSPC at any point during the study period.
- At least one dispensing of darolutamide or enzalutamide or apalutamide or abiraterone acetate/methylprednisolone, initiated for the first time during the patient identification period for mHSPC
- Age ≥18 years at index date.
- At least 12 months of data prior to index date (a sensitivity analysis will also be conducted using 6 months pre-index period)
- At least 3 months of data after index date (a sensitivity analysis will also be conducted using 6 months post-index period)
Exclusion
- Evidence of prior use of ARPI, including darolutamide, enzalutamide, apalutamide, or abiraterone/methylprednisolone, before the index date
- Evidence of castration resistant prostate cancer (CRPC), either metastatic or nonmetastatic, before or on the index date, proxied by timing of medications in use.
Key Trial Info
Start Date :
November 7 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT07223372
Start Date
November 7 2025
End Date
November 30 2026
Last Update
October 31 2025
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