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

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.

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Key information

Conditions

Prostate Cancer Androgen-deprivation Therapy Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Heart Diseases Infarction Ischemia Ischemic Stroke Male Urogenital Diseases Myocardial Infarction Myocardial Ischemia Necrosis Neoplasms Neoplasms by Site Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Stroke Urogenital Diseases Urogenital Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

CHU de Rennes

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard care

Other

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.

Primary outcomes

Association between androgen-deprivation therapy and vascular stroke

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: ADTCR

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2022
First posted: Sep 9, 2016
Registry last updated: Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed