Actively Recruiting

Age: 18Years +
MALE
NCT07223372

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

Led by Bayer · Updated on 2026-04-15

1000

Participants Needed

1

Research Sites

59 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients with evidence of metastatic hormone-sensitive prostate cancer at any time during the study period
  • At least one dispensing of darolutamide, enzalutamide, apalutamide, or abiraterone acetate/methylprednisolone initiated for the first time during the patient identification period for mHSPC
  • Age 18 years or older at index date
  • At least 12 months of prescription data before the start of treatment
  • At least 3 months of prescription data after the start of treatment
Not Eligible

You will not qualify if you...

  • Prior use of any Androgen Receptor Pathway Inhibitor including darolutamide, enzalutamide, apalutamide, or abiraterone/methylprednisolone before the treatment start date
  • Evidence of castration resistant prostate cancer before or on the treatment start date

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Bayer

Pymble, New South Wales, Australia, 875

Actively Recruiting

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Research Team

B

Bayer Clinical Trials Contact

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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