- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02895230
Androgen-Deprivation Therapy and Cardiovascular Risk: A Nationwide Population-based Cohort Study (ADTCR)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Rennes, France, 35033
- Chu de Rennes
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Association between androgen-deprivation therapy and vascular stroke
Time Frame: 2 years after the beginning of androgen-deprivation therapy
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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.
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2 years after the beginning of androgen-deprivation therapy
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Emmanuel OGER, MD, PhD, CHU Rennes
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC13_8812
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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