A Study to Learn About Heart-Related Risks in Elderly Men With Advanced Prostate Cancer Treated With Enzalutamide or Darolutamide

NCT07672119 · tracked via the Priya Life Science USA tracker

Sponsor

Bayer

Phase

Observational

Started

2026-06-04

Last updated

2026-06-26

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

No intervention

No intervention: Retrospective analysis using database without any intervention assigned in the study.

Study summary

This observational study aims to better understand the risk of serious heart-related problems in older men with advanced prostate cancer who are treated with certain commonly used medicines.

Prostate cancer is the most commonly diagnosed malignancy in United States (US) men and a leading cause of cancer mortality, with disease progression spanning multiple clinical states, including non-metastatic castrate resident prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC).

Men with advanced prostate cancer are often treated with medicines such as darolutamide or enzalutamide. While these treatments can help control cancer, they may also increase the risk of heart-related side effects, such as heart attack, stroke, or death related to heart and blood vessel disease. However, it is not yet clear whether these risks differ between the two treatments or which patients may be more likely to experience them.

The main goal of the study is to compare how often serious heart-related events (such as heart attack, stroke, or death due to heart problems) occur in patients treated with these two medicines. The study will also explore other heart-related conditions and identify factors that may increase this risk.

In this study, researchers will use existing healthcare data from the United States to look at men aged 55 years and older with advanced prostate cancer who have already been treated with either darolutamide or enzalutamide in routine clinical practice. No new treatments will be given as part of this research. Because this is a retrospective database study, there are no extra study visits, no extra blood tests, and no extra health check-ups required for participants.

Eligibility

Sex

MALE

Min age

55 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Incidence proportion and incidence rate (per 100 person-years) of 3-point major cardiovascular event (MACE) — Retrospective analysis from 01-Aug-2018 up to 31-Dec-2025 (or the most recent available data at the time of analysis)
Risk will be estimated as the time from the index date to the first 3-point MACE event. MACE: major cardiovascular event (composite of myocardial infarction \[MI\], stroke, or cardiovascular \[CV\] death)).
Estimation of the association of risk factors with 3-point MACE — Retrospective analysis from 01-Aug-2018 up to 31-Dec-2025 (or the most recent available data at the time of analysis)
A multivariable Cox regression model will be performed to estimate the hazard ratio associated with each risk factor. MACE: major cardiovascular event (MI, stroke or CV death).

Trial sites (1)

Facility	City	Region	Status
Bayer	Whippany	New Jersey	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07672119 on ClinicalTrials.gov ↗ ← All trials in the USA