Recruiting

Advanced prostate cancer

Bayer Identifier:

23348

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available

An Observational Study to Learn about Heart-Related Risks in Elderly Men with Advanced Prostate Cancer Treated with Enzalutamide or Darolutamide

Trial purpose

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 Participants Requirements

Sex

Male

Age

55 - N/A (No Limit)

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
• ≥12 months of continuous medical and pharmacy enrollment before and ≥2 months of
continuous medical and pharmacy enrollment after the index date unless dead.

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.

Trial summary

Enrollment Goal

3000

Trial Dates

June 2026 - April 2027

Phase

Phase IV

Could I Receive a placebo

Products

Darolutamide, BAY 1841788

Accepts Healthy Volunteer

Primary Outcome

Incidence proportion and incidence rate (per 100 person-years) of 3-point MACE (myocardial infarction [MI], stroke, or cardiovascular [CV] death) among patients treated with darolutamide or enzalutamide for advanced prostate cancer
Risk will be estimated as the time from the index date to the first 3-point MACE event. A 3-point MACE event is defined as a diagnosis claim with an acute MI, acute stroke, or CV death ICD-10-CM diagnosis code listed in the first position, whichever occurs first. CV death will be defined as death within 30 days following a significant CV-related event. MACE: major cardiovasvular event
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 factors associated with 3-point MACE
MACE: major cardiovascular event (MI, stroke or CV death)
Time Frame:
Retrospective analysis from 01-Aug-2018 up to 31-Dec-2025 (or the most recent available data at the time of analysis)

Secondary Outcome

Incidence proportion and incidence rate (per 100 Person-years) of MACE-3m among patients treated with darolutamide or enzalutamide for advanced prostate cancer
Risk will be estimated as the time from the index date to the first modified 3-point MACE (MACE-3m) event. A MACE-3m event is defined as a diagnosis claim with an acute MI, acute stroke, or all-cause death ICD-10-CM diagnosis code listed in the first position, whichever occurs first.
Time Frame:
Retrospective analysis from 01-Aug-2018 up to 31-Dec-2025 (or the most recent available data at the time of analysis)
Incidence proportion and incidence rate (per 100 person-years) of 4-point MACE among patients treated with darolutamide or enzalutamide for advanced prostate cancer
Risk will be estimated as the time from the index date to the first 4-point MACE event. A 4-point MACE event is defined as a diagnosis claim with an acute MI, acute stroke, CV death, or unstable angina/revascularization (UA/R) ICD-10-CM diagnosis code listed in the first position, whichever occurs first.
Time Frame:
Retrospective analysis from 01-Aug-2018 up to 31-Dec-2025 (or the most recent available data at the time of analysis)

Trial design

MACED: Major adverse cardiovascular events among elderly patients treated with enzalutamide or darolutamide among patients with advanced prostate cancer

Trial Type

Observational

Intervention Type

Other

Trial Purpose

N/A

Allocation

N/A

Blinding

Open Label

Assignment

N/A

Trial Arms

N/A