Use of anti-androgen medicines in men with metastatic hormone-sensitive 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)

This project looks at prescription records to see how androgen receptor pathway inhibitor medicines are being used with hormone therapy in adult men in Australia who have metastatic hormone-sensitive prostate cancer.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Bayer (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Pymble, New South Wales)
• Trial ID: NCT07223372 on ClinicalTrials.gov

What this trial studies

This retrospective observational analysis uses de-identified prescription data from the Australian Pharmaceutical Benefits Scheme (PBS) and the NostraData retail pharmacy dataset to describe real-world treatment patterns for metastatic hormone-sensitive prostate cancer (mHSPC). The study identifies adult men who initiated an androgen receptor pathway inhibitor (darolutamide, enzalutamide, apalutamide, or abiraterone) during the patient identification period and requires at least 12 months of prior data and 3 months of follow-up for the primary analysis, with sensitivity analyses using 6-month windows. Researchers will report patient characteristics, proportions receiving doublet therapy (ARPI + ADT) or triplet therapy (ARPI + ADT + docetaxel), sequencing of therapies, and other prescription patterns over time. Patients with prior ARPI use or evidence of castration-resistant prostate cancer before the index date will be excluded to focus the cohort on hormone-sensitive disease.

Who should consider this trial

Good fit: Adult men in Australia with metastatic hormone-sensitive prostate cancer who started an ARPI (darolutamide, enzalutamide, apalutamide, or abiraterone) for the first time during the study period and who have sufficient prescription data available are the intended cohort.

Not a fit: Patients outside Australia, those with castration-resistant prostate cancer, those who began ARPI treatment before the study identification date, or those without adequate prescription history are unlikely to be represented or directly benefit from the study findings.

Why it matters

Potential benefit: If successful, the findings could help clinicians and policymakers understand real-world treatment use and identify gaps in care or access to ARPI combinations for men with mHSPC in Australia.

How similar studies have performed: Similar real-world prescribing analyses of ARPIs in other countries have described treatment patterns and outcomes, but Australian-specific, large-database analyses are limited, so this work builds on existing international literature.

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.

Where this trial is running

Pymble, New South Wales

• Bayer — Pymble, New South Wales, Australia (Recruiting)

Study contacts

• Study coordinator: Bayer Clinical Trials Contact

Conditions Metastatic Hormonesensitive Prostate Cancer