CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 52,000 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT06902441
NCT06902441N/ACompleted

Impact of Androgen Receptor Signaling Inhibitors on Cardiovascular Events in Prostate Cancer: a Pharmacoepidemiology Study Using the French Health Care Claims Database

University Hospital, Caen·observational·Posted Mar 30, 2025·Updated Jul 4, 2025

In Brief

An observational study for Prostate Cancer. Completed, enrolled 52,000 participants across 1 site.

Detailed Summary

In prostate cancer, whether advanced or localized, hormone therapy is a key treatment. These therapies work by lowering male hormone levels to slow the growth of cancer. More recently, a new group of medications called Androgen Receptor Signaling Inhibitors (ARSIs) has been introduced. These drugs are used alongside standard hormone therapy and are now prescribed for both advanced and high-risk localized prostate cancer. There are two main types of ARSIs: abiraterone acetate, which blocks the body from making androgens, and enzalutamide, apalutamide, and darolutamide, which stop cancer cells from using these hormones. Doctors choose among them based on individual patient needs, as no one drug has been clearly shown to be better than the others. These treatments have significantly improved survival for many patients. However, research shows that 30% of men with prostate cancer die from heart-related issues-a higher rate than in the general population. It's important to better understand how these treatments might be linked to heart risks. One study found that all ARSIs increase the risk of serious heart problems. However, it did not take into account whether patients already had heart conditions, even though previous heart issues are known to increase the risk with certain drugs like abiraterone and enzalutamide. That's why we're conducting a study using a large real-world database to compare the heart risks of abiraterone, enzalutamide, and apalutamide. We will take into account both patients' existing heart conditions and how long they were on treatment.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
20252026
First PostedMar 30, 2025
Enrollment StartJan 7, 2025
Primary CompletionJun 30, 2025
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 1.3 years ago