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临床试验/NCT07223372
NCT07223372招募中不适用

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

Bayer1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年10月10日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Number and proportion of patients taking each ARPI as a percentage of total study population.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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.

研究组 & 干预措施

Cohort 1

Patients who received darolutamide

Cohort 2

Patients who received enzalutamide

Cohort 3

Patients who received apalutamide

Cohort 4

Patients who received abiraterone/methylprednisolone

结局指标

主要结局

Number and proportion of patients taking each ARPI as a percentage of total study population.

时间窗: Retrospective analysis from December 2022 to June 2025

Demographic characteristics of mHSPC patients

时间窗: Retrospective analysis from December 2022 to June 2025

次要结局

  • Proportion of days covered (PDC) to understand adherence(Retrospective analysis from December 2022 to June 2025)
  • Starting dose and change in dose over time(Retrospective analysis from December 2022 to June 2025)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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