NCT07223372 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bayer |
| Condition | Metastatic Hormonesensitive Prostate Cancer (mHSPC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-10-10 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-10-10 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07223372 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Metastatic Hormonesensitive Prostate Cancer (mHSPC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07223372 currently recruiting?
Yes, NCT07223372 is actively recruiting participants. Contact the research team at clinical-trials-contact@bayer.com for enrollment information.
Where is the NCT07223372 trial being conducted?
This trial is being conducted at Pymble, Australia.
Who is sponsoring the NCT07223372 clinical trial?
NCT07223372 is sponsored by Bayer. The trial plans to enroll 1,000 participants.
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