NCT07672119 · Bayer
A Study to Learn About Heart-Related Risks in Elderly Men With Advanced Prostate Cancer Treated With Enzalutamide or Darolutamide
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
No intervention
Retrospective analysis using database without any intervention assigned in the study.
Primary outcome measures
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)).
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Whippany, New Jersey
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations