Bayer
Pymble, New South Wales, 875, Australia
Location status: Recruiting
NCT Number: NCT07223372
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.
Interested in participating?
Request Info18 year and older
Male
Observational
Pymble, New South Wales, 875, Australia
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Retrospective analysis from December 2022 to June 2025
Time frame: Retrospective analysis from December 2022 to June 2025
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
Time frame: Retrospective analysis from December 2022 to June 2025
Contact information is provided by the study sponsor or research team.
Bayer
Industry
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
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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.