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

Recruiting now

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT07672119

Run by

Bayer

People needed

3000

Starts

2026-06-04

Expected to finish

2027-04-29

Last updated by the study team

2026-06-26

Who can join

Age: 55 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Bayer — Whippany, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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