Clinical trial · Observational
Androgen-Deprivation Therapy and Cardiovascular Risk: A Nationwide Population-based Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Androgen-deprivation Therapy | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Men with prostate cancer with androgen-deprivation therapy
- description
- 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).
- interventionNames
- Other: Standard care
Primary outcomes (1)
- measure
- Association between androgen-deprivation therapy and vascular stroke
- timeFrame
- 2 years after the beginning of androgen-deprivation therapy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTScailteux 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
- RESULTScailteux 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