Heart-risk in older men with advanced prostate cancer treated with enzalutamide or darolutamide

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study that compares the frequency of serious heart-related events among older men with advanced prostate cancer who are treated with two approved anti-androgen medications. Participants are men aged 55 and older with metastatic hormone-sensitive or non-metastatic castration-resistant disease who have evidence of ARPI treatment with enzalutamide or darolutamide. The study uses existing prescription and medical data to identify outcomes without assigning any treatments. No intervention is performed as part of the study. The goal is to see if one medication is associated with more cardiovascular events than the other and to identify patient factors that may influence risk.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male diagnosed with prostate cancer
* Evidence of ≥2 prescription claims for enzalutamide or darolutamide during the identification period with the first occurrence of ARPI treatment defined as the index date
* Male patients with a diagnosis of mHSPC or nmCRPC before or on the index date
* Aged ≥55 years on the index date

Exclusion Criteria:

* Use of any of the ARPIs (abiraterone, apalutamide, enzalutamide, and darolutamide), Evidence of CRPC prior to the index date for mHSPC
* Evidence of metastasis before index date + 30 days for nmCRPC

Where it's running

• Bayer
  Whippany, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: 18888422937

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.