Spots Global Cancer Trial Database for Androgen-Deprivation Therapy and Cardiovascular Risk: A Nationwide Population-based Cohort Study

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Trial Identification

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

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

Study ID: NCT02895230

Conditions

Prostate Cancer

Androgen-deprivation Therapy

Interventions

Standard care

Study Description

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.