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

NCT ID: NCT07223372

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-07
• Study Completion Date: 2026-11-30

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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cohort 1

Patients who received darolutamide

No interventions assigned to this group

Cohort 2

Patients who received enzalutamide

No interventions assigned to this group

Cohort 3

Patients who received apalutamide

No interventions assigned to this group

Cohort 4

Patients who received abiraterone/methylprednisolone

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Bayer Clinical Trials Contact

Role: CONTACT

Phone: (+)1-888-84 22937

Email: clinical-trials-contact@bayer.com

Other Identifiers

23084

Identifier Type: -

Identifier Source: org_study_id