Androgen-Deprivation Therapy and Cardiovascular Risk: A Nationwide Population-based Cohort Study (ADTCR)
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|ClinicalTrials.gov Identifier: NCT02895230|
Recruitment Status : Unknown
Verified April 2017 by Rennes University Hospital.
Recruitment status was: Recruiting
First Posted : September 9, 2016
Last Update Posted : April 11, 2017
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.
|Condition or disease||Intervention/treatment|
|Prostate Cancer Androgen-deprivation Therapy||Other: Standard care|
|Study Type :||Observational|
|Estimated Enrollment :||2700 participants|
|Official Title:||Androgen-Deprivation Therapy and Cardiovascular Risk: A Nationwide Population-based Cohort Study|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
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
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02895230
|Contact: Emmanuel OGER, MD, PhDfirstname.lastname@example.org|
|Contact: Anne HESPEL, PhDemail@example.com|
|CHU de Rennes||Recruiting|
|Rennes, France, 35033|
|Contact: Emmanuel Oger, MD, PhD 33 2 99 28 58 87 firstname.lastname@example.org|
|Study Director:||Emmanuel OGER, MD, PhD||CHU Rennes|