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

NCT07223372 | Recruiting

• 1 other identifier: 23084
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Hormonesensitive Prostate Cancer (mHSPC)

Outcome Measures

Primary Outcomes (2)

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

  Retrospective analysis from December 2022 to June 2025

• Demographic characteristics of mHSPC patients

  Retrospective analysis from December 2022 to June 2025

Secondary Outcomes (2)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is a retrospective, observational analysis of prescription data collected in Australia from real-world data sources: the Pharmaceutical Benefits Scheme (PBS) 10% sample data and NostraData. Target population were adult male mHSPC patients who initiated ARPI therapy within the study period, either in doublet or triplet therapy with ADT and/or docetaxel.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Bayer

Pymble, New South Wales, 875, Australia

RECRUITING

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

(+)1-888-84 22937; clinical-trials-contact@bayer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2025
• First Posted: October 31, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)