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

NCT02895230 | Completed

• 1 other identifier: 35RC13_8812
• Study Type: observational
• Target: 38,690
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Androgen-deprivation Therapy

Keywords

Androgen-deprivation therapy; Prostate cancer; Nationwide population-based cohort; Myocardial infarction; Ischemic stroke

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Men with prostate cancer with androgen-deprivation therapy

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).

Other: Standard care

Interventions

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.

Men with prostate cancer with androgen-deprivation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 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).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

Related 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 study based on 2010-2013 French Health Insurance data. Eur J Cancer. 2017 May;77:99-108. doi: 10.1016/j.ejca.2017.03.002. Epub 2017 Apr 5.

  PMID: 28390298 RESULT

• 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.

  PMID: 28756060 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms; Myocardial Infarction; Ischemic Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Emmanuel OGER, MD, PhD

  CHU Rennes

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 9, 2016
• Study Start: January 1, 2016
• Primary Completion: March 21, 2016
• Study Completion: May 17, 2022
• Last Updated: August 1, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)