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NCT Number: NCT07672119

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

55 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Retrospective analysis using database without any intervention assigned in the study.

Primary outcomes

  1. Incidence proportion and incidence rate (per 100 person-years) of 3-point major cardiovascular event (MACE)

    Time frame: 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)).

  2. Estimation of the association of risk factors with 3-point MACE

    Time frame: 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).

Secondary outcomes

  1. Incidence proportion and incidence rate (per 100 person-years) of modified 3-point MACE (MACE-3m)

    Time frame: 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 MACE-3m event. MACE-3m: composite of acute MI, acute stroke, or all-cause death.

  2. Incidence proportion and incidence rate (per 100 person-years) of 4-point MACE

    Time frame: 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 4-point MACE event. 4-point MACE: composite of acute MI, acute stroke, CV death, or unstable angina/revascularization.

Study contacts

Contact information is provided by the study sponsor or research team.

Bayer Clinical Trials Contact

CONTACT

[email protected]

18888422937

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

MACED: Major Adverse Cardiovascular Events Among Elderly Patients Treated With Enzalutamide or Darolutamide Among Patients With Advanced Prostate Cancer

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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