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

Part of paid clinical trials in Whippany, New Jersey.

Sponsor
Bayer
Study ID
NCT07672119
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • No intervention — OTHER
    Retrospective analysis using database without any intervention assigned in the study.

Study Details

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 Dates

Start date
Jun 4, 2026
Status verified
Jun 2026
Primary completion
Apr 29, 2027
Completion
Apr 29, 2027

Study Design

Enrollment
3,000 participants (estimated)

Arms

  • Arm: Advanced prostate cancer
    Participants will be assigned to mutually exclusive cohorts based on the index treatment of either enzalutamide or darolutamide and their diagnosis as mHSPC or nmCRPC.

Primary Outcome Measure

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
BayerWhippanyNew Jersey07981
Bayer US
[email protected]
888-842-2937

Find similar trials in Whippany, NJ

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Bayer· Whippany, NJ

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