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Recruiting

NCT Number: NCT07223372

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

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 proportion of patients receive doublet therapy (ARPI + ADT) or triplet therapy (ARPI + ADT + docetaxel chemotherapy). It will also describe the characteristics of the patients receiving these therapies, such as their age and location. Secondary goals include understanding how well patients adhere to their prescribed ARPI treatment and tracking any changes in medication dosage over time. Since the study uses existing, anonymized data, there is no direct contact with patients and individual patient consent is not required. The findings will provide valuable real-world insights into the use of ARPIs in Australia, which can help inform clinical practice and improve care for men with mHSPC.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Bayer

Pymble, New South Wales, 875, Australia

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. Demographic characteristics of mHSPC patients

    Time frame: Retrospective analysis from December 2022 to June 2025

Secondary outcomes

  1. Proportion of days covered (PDC) to understand adherence

    Time frame: Retrospective analysis from December 2022 to June 2025

    Evaluation of treatment adherence from treatment initiation using a proportion of days covered (PDC) analysis. PDC is calculated as the number of days with medication available divided by the total number of days in the observations period, starting from ARPI (Andorgen receptor pathway inhibitor) initiation

  2. Starting dose and change in dose over time

    Time frame: Retrospective analysis from December 2022 to June 2025

Study contacts

Contact information is provided by the study sponsor or research team.

Bayer Clinical Trials Contact

CONTACT

[email protected]

(+)1-888-84 22937

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Treatment Patterns and Characteristics of Patients Receiving Androgen Receptor Pathway Inhibitors in a Real-world Setting in -Australia: A Retrospective Prescriptions Data Study (TARA)

Acronym: TARA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 31, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.