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

Prostate Cancer Clinical Trial

— ADTCR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895230
• Other study ID #: 35RC13_8812
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: May 17, 2022

Study information

• Verified date: December 2022
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38690
• Est. completion date: May 17, 2022
• Est. primary completion date: March 21, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Androgen-deprivation Therapy
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (2)

Scailteux LM, Vincendeau S, Balusson F, Leclercq C, Happe A, Le Nautout B, Polard E, Nowak E, Oger E. Androgen deprivation therapy and cardiovascular risk: No meaningful difference between GnRH antagonist and agonists-a nationwide population-based cohort — View Citation

Scailteux LM. Response to letter - Androgen deprivation therapy and cardiovascular risk: No meaningful difference between GnRH antagonist and agonists. Eur J Cancer. 2017 Dec;87:204. doi: 10.1016/j.ejca.2017.06.042. Epub 2017 Jul 26. No abstract available — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between androgen-deprivation therapy and vascular stroke	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.	2 years after the beginning of androgen-deprivation therapy