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 | Completed

• 1 other identifier: 20250318
• Study Type: observational
• Target: 52,000
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Keywords

Prostate cancer; Androgen Receptor Signaling Inhibitors; Cardiovascular toxicity; Hormonotherapy; Pharmacoepidemiology

Outcome Measures

Primary Outcomes (1)

• Risk of hospitalization for cardiovascular cause

  The primary objective of this study was to compare the risk of hospitalization for cardiovascular reasons among the different Androgen Receptor Signaling Inhibitors (ARSI). This outcome was evaluated by the occurrence of a hospitalization for one of these reasons as the principal diagnosis.

  From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome

Secondary Outcomes (7)

• Risk of hospitalization for hearth failure

  From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome

• Risk of hospitalization for atrial fibrillation

  From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome

• Risk of hospitalization for ischemic heart disease

  From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome

• Risk of hospitalization for hypertensive disease

  From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome

• Risk of hospitalization for successfully resuscitated cardiac arrest

  From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome

Study Arms (3)

Apalutamide

Data collected about patients treated with Apalutamide

Abiraterone Acetate

Data collected about patients treated with Abiraterone Acetate

Enzalutamide

Data collected about patients treated with Enzalutamide

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with prostatic cancer treated with an ARSI amoung Abiraterone Acetate, Enzalutamide or Apalutamide.

You may qualify if:

• Patients had to begin a treatment with Enzalutamide, Abiraterone or Apalutamide between the 01-01-2018 and the 31-12-2022
• Patients must have a unique ID in the database, to be able to link the data

You may not qualify if:

• Previous treatment with another novel androgen receptor signaling inhibitors
• Patients were excluded if they began a chemotherapy treatment in the 6 weeks following the beginning of Androgen Receptor Signaling Inhibitors (ARSI)

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU Caen

Caen, Normandy, 14000, France

Location

Related Publications (5)

• Baser O, Samayoa G, Dwivedi A, AlSaleh S, Cigdem B, Kizilkaya E. Cardiovascular events among patients with prostate cancer treated with abiraterone and enzalutamide. Acta Oncol. 2024 Apr 9;63:137-146. doi: 10.2340/1651-226X.2024.20337.

  PMID: 38591349 BACKGROUND

• Lu-Yao G, Nikita N, Keith SW, Nightingale G, Gandhi K, Hegarty SE, Rebbeck TR, Chapman A, Kantoff PW, Cullen J, Gomella L, Kelly WK. Mortality and Hospitalization Risk Following Oral Androgen Signaling Inhibitors Among Men with Advanced Prostate Cancer by Pre-existing Cardiovascular Comorbidities. Eur Urol. 2020 Feb;77(2):158-166. doi: 10.1016/j.eururo.2019.07.031. Epub 2019 Aug 13.

  PMID: 31420248 BACKGROUND

• El-Taji O, Taktak S, Jones C, Brown M, Clarke N, Sachdeva A. Cardiovascular Events and Androgen Receptor Signaling Inhibitors in Advanced Prostate Cancer: A Systematic Review and Meta-Analysis. JAMA Oncol. 2024 Jul 1;10(7):874-884. doi: 10.1001/jamaoncol.2024.1549.

  PMID: 38842801 BACKGROUND

• Ye Y, Zheng Y, Miao Q, Ruan H, Zhang X. Causes of Death Among Prostate Cancer Patients Aged 40 Years and Older in the United States. Front Oncol. 2022 Jul 1;12:914875. doi: 10.3389/fonc.2022.914875. eCollection 2022.

  PMID: 35847902 BACKGROUND

• Ploussard G, Baboudjian M, Barret E, Brureau L, Fiard G, Fromont G, Olivier J, Dariane C, Mathieu R, Rozet F, Peyrottes A, Roubaud G, Renard-Penna R, Sargos P, Supiot S, Turpin L, Roupret M; Comite de Cancerologie de l'Association Francaise d'Urologie, Groupe Prostate, Maison de l'Urologie. French AFU Cancer Committee Guidelines - Update 2024-2026: Prostate cancer - Diagnosis and management of localised disease. Fr J Urol. 2024 Nov;34(12):102717. doi: 10.1016/j.fjurol.2024.102717.

  PMID: 39581668 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: January 7, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-03

Locations

FR (1)