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

Recruitingn/aAges 55 Years - anyMaleBayer
NCT07672119 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 patien

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📋 Eligibility rules (as published)
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
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What it tests

  • No intervention
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Where

1 site
Bayer
Whippany, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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