Use of anti-androgen medicines in men with metastatic hormone-sensitive prostate cancer in Australia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Bayer
  Pymble, New South Wales, Australia Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: (+)1-888-84 22937

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.