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

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ClinicalTrials.gov Identifier: NCT02895230
Recruitment Status : Recruiting
First Posted : September 9, 2016
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.


Condition or disease Intervention/treatment
Prostate Cancer Androgen-deprivation Therapy Other: Standard care

Detailed 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.

Study Type : Observational
Estimated Enrollment : 2700 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Emmanuel OGER, MD, PhD emmanuel.oger@chu-rennes.fr
Contact: Anne HESPEL, PhD anne.hespel@chu-rennes.fr

Locations
France
CHU de Rennes Recruiting
Rennes, France, 35033
Contact: Emmanuel Oger, MD, PhD    33 2 99 28 58 87    emmanuel.oger@univ-rennes1.fr   
Sponsors and Collaborators
Rennes University Hospital
Investigators
Study Director: Emmanuel OGER, MD, PhD CHU Rennes

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02895230     History of Changes
Other Study ID Numbers: 35RC13_8812
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rennes University Hospital:
Androgen-deprivation therapy
Prostate cancer
Nationwide population-based cohort
Myocardial infarction
Ischemic stroke

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs