Androgen-Deprivation Therapy and Cardiovascular Risk: A Nationwide Population-based Cohort Study

Completed

• Conditions: Prostate Cancer; Androgen-deprivation Therapy
• Interventions: Other: Standard care

• Registration Number: NCT02895230
• Lead Sponsor: Rennes University Hospital

Brief Summary

The research focuses on the safety profile of androgen-deprivation therapy (ADT). The hypothesis is that safety issue, as regards to cardiovascular risk, is not homogenous across the spectrum of androgen-deprivation therapy modalities. Our study will encompass all ADT modalities including intermittent ADT.

ADT is a cornerstone therapy in prostate cancer management. Decisions about ADT should weigh improvements in cancer-specific outcomes against potential increased risks for cardiovascular diseases. The potential for harm from ADT should be more precisely defined according to the type of ADT. Those potential risks underscore the importance of better understanding benefits of ADT, especially in contexts where data are still lacking.ADT is also indicated in sexually deviant behavior.

Detailed Description

Our study is a nationwide population-based prospective cohort on 4 years thanks to the French Health Reimbursement Agency database (Système National d'Information Inter-Régimes de l'Assurance Maladie, SNIIRAM) and French hospital discharge database (Programme de Médicalisation des Systèmes d'Information; PMSI). A unique civil registration number has been assigned to all French residents and this number unambiguously links those two databases.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-03-21
• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-09
• Study Completion: 2022-05-17
• Status Verified: 2022-12
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 38690

Inclusion Criteria

• Adults men, age greater 18 years,
• Affiliation to French Health System,
• Diagnosis of prostate cancer
• At least one dispensation (leading to a reimbursement claim) in a 1.5 year period of an androgen-deprivation therapy or a hospitalization for orchiectomy.

Exclusion Criteria

• Orchiectomy for another reason that prostate cancer.
• Patients treated with both Gonadotropin Releasing Hormone agonists and bilateral orchiectomy will be excluded from analyses.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Men with prostate cancer with androgen-deprivation therapy	Standard care	Using the French Health Reimbursement Agency database and French hospital discharge database, the investigators will identify all men with prostate cancer who had either, at least one dispensation in a 1.5-year period (1st July 2010 to 31st December 2011) of an androgen-deprivation therapy or a hospitalization for orchiectomy. The French Health Insurance System covers the entire French population (65.3 million inhabitants in 2012).

Primary Outcome Measures

Name	Time	Method
Association between androgen-deprivation therapy and vascular stroke	2 years after the beginning of androgen-deprivation therapy	To investigate the association between different modalities of androgen-deprivation therapy (continuous or intermittent use of Gonadotropin Releasing Hormone (GnRH) agonists, GnRH antagonists, oral antiandrogens, or orchiectomy) and myocardial infarction or ischemic stroke in French men with prostate cancer.

Trial Locations

Locations (1)

CHU de Rennes; 🇫🇷 Rennes, France