An Observational Study to Learn More About How Medicines That Block Male Hormones Are Used in People With Prostate Cancer in Australia
Treatment Patterns and Characteristics of Patients Receiving Androgen Receptor Pathway Inhibitors in a Real-world Setting in -Australia: A Retrospective Prescriptions Data Study (TARA)
Sponsor: Bayer
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number and proportion of patients taking each ARPI as a percentage of total study population.
Time frame: Retrospective analysis from December 2022 to June 2025
Demographic characteristics of mHSPC patients
Time frame: Retrospective analysis from December 2022 to June 2025
Secondary Endpoints
Proportion of days covered (PDC) to understand adherence
Starting dose and change in dose over time
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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