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Impact of New Hormonotherapy Drugs in Prostatic Cancer on the Risk of Cardiovascular Events : a Pharmacoepidemiology Study Using the French Health Care Claims Database

NCT06902441 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 52000

Last updated 2025-07-04

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-07
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06902441 on ClinicalTrials.gov