Prostate Cancer
Conditions
Brief summary
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
OTHERNo intervention
Retrospective analysis using database without any intervention assigned in the study.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence proportion and incidence rate (per 100 person-years) of 3-point major cardiovascular event (MACE) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence proportion and incidence rate (per 100 person-years) of modified 3-point MACE (MACE-3m) | 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. |
| Incidence proportion and incidence rate (per 100 person-years) of 4-point MACE | 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. |
Countries
United States
Contacts
CONTACTBayer Clinical Trials Contact
Outcome results
None listed