NCT02895230

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 38,690 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Androgen-deprivation Therapy

Interventions

Type	Name	Description
OTHER	Standard care	An extraction from French Health Reimbursement Agency database and French hospital discharge database will be performed using a simplified request based on inclusion criteria but the extraction will encompass a 4-year period to ensure sufficient follow-up.

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-03-21
• Completion: 2022-05-17
• First posted: 2016-09-09
• Last updated: 2023-08-01

Locations

1 site across 1 country: France