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An Observational Study to Learn More About How Medicines That Block Male Hormones Are Used in People With Prostate Cancer in Australia

Recruitingn/aAges 18 Years - anyMaleBayer
NCT07223372 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 prostate cancer that has spread but still responds to hormone therapy. The main goal is to understand the treatment patterns, characteristics, and outcomes for patients who are receiving a class of drugs called Androgen Receptor Pathway Inhibitors (ARPIs), such as darolutamide, enzalutamide, apalutamide, or abiraterone. These drugs are often used in combination with standard Androgen Deprivation Therapy (ADT). The research will use two large, de-identified Australian prescription databases: the Pharmaceutical Benefits Scheme (PBS) and the NostraData retail pharmacy dataset. By analyzing this information, the study aims to describe how these treatments are being used over time, including what

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
Bayer
Pymble, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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