Actively Recruiting
Heart-Related Risks in Older Men with Advanced Prostate Cancer Treated with Enzalutamide or Darolutamide An Observational Study
Led by Bayer · Updated on 2026-06-26
3000
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating the risk of serious heart-related problems in older men with advanced prostate cancer who have been treated with the medicines darolutamide or enzalutamide. Prostate cancer is a common and serious illness in men, and while these medicines help control the disease, they may also increase the chance of heart attacks, strokes, or death from heart and blood vessel disease. The study aims to compare how often these serious heart events occur between the two treatments and to identify which patients may be at higher risk. This observational study uses existing healthcare data from men aged 55 years and older in the United States who have already received either darolutamide or enzalutamide as part of their routine care for advanced prostate cancer. Participants are grouped based on their treatment and diagnosis of metastatic hormone-sensitive prostate cancer or non-metastatic castrate resistant prostate cancer. Since this is a retrospective database study, no new treatments, extra visits, blood tests, or health check-ups are required. Participants are not required to attend any study visits as the research analyzes past medical records. Researchers will measure the rates of major cardiovascular events such as heart attacks and strokes, and assess risk factors for these events using data collected from August 2018 through December 2025 or the most recent available. The study is supported by Bayer and aims to improve understanding of heart-related risks associated with these prostate cancer treatments.
CONDITIONS
Brief Title
A Study to Learn About Heart-Related Risks in Elderly Men With Advanced Prostate Cancer Treated With Enzalutamide or Darolutamide
Research Team
B
Bayer Clinical Trials Contact
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