Evaluation of the Potential Association Between 5α-reductase Inhibitors Prescription and Occurrence of High Grade Prostate Cancers (CANARI)

February 23, 2018 updated by: Rennes University Hospital
This is a multicenter, cohort study based on medico-administrative data from pathology laboratory registries and drug reimbursement files (CNAM-TS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Identification process will be retrospective and prospective using medico-administrative data from all pathology laboratory registries in Brittany and drug reimbursement files for patients living in Brittany, France.

An extraction from drug reimbursement files of French health reimbursement agency (CNAM-TS) for patients living in Brittany, France will be performed on the following request: reimbursement of any pharmacologic treatment patented for symptomatic benign hyperplasia between January 1st 2010 and December 31st 2011, and no diagnosis of prostate cancer before December 31st, 2011. This extraction has to be done in 2013 to catch data as far as 2010 and will encompass health reimbursement for prostate examination. A second extraction will be done in 2014 to complete data from the end of 2013.

Secondly, identification of patients will use pathology laboratory registries, based on code for prostate examination (prostate biopsy, prostatectomy or prostate resection); involvement of all pathology laboratories in Brittany ensures completeness of collection of prostate examination results for the study period (January 1st, 2012 to December 31st, 2013). A list of patients will be recorded at each pathology laboratory level with date of birth, date of prostate examination, type of exam, results with Gleason score along with a study number on electronic file.

By January 2014, link to reimbursement file (that is data on all reimbursement within 3 years: 2009 to 2011 previously extracted from the French health reimbursement agency) will be done thanks to three key variables (date of birth, date of prostate examination, identification of pathology laboratory) and all data from all centers will set up into one global file.

This design will allow evaluation of association between 5-ARI and either high grade prostate cancer or low grade prostate as opposite association could be observed. In addition this design focuses on the target population, i.e. patients with symptomatic benign prostate hyperplasia, identified through reimbursement of drugs patented for symptomatic benign prostate hyperplasia.

Study Type

Observational

Enrollment (Actual)

5154

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • Chu de Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Men treated for benign prostate hyperplasia

Description

Inclusion Criteria:

  • Men with a reimbursement of any pharmacologic treatment patented for symptomatic benign prostate hyperplasia between January 1st 2010 and December 31st 2011, affiliated to French health system and living in Brittany, France.

Exclusion Criteria:

  • Prostate cancer with a date of diagnosis before December 31st, 2011, patients enrolled in surveillance program with scheduled prostate biopsy, patients not affiliated to French health system.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
5 alpha reductase inhibitor
Other: Prostate biopsy, prostatectomy or prostate resection
Collection of prostate examination
Any other drug for benign prostate hyperplasia
Other: Prostate biopsy, prostatectomy or prostate resection
Collection of prostate examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
High grade (Gleason >= 7) prostate cancer
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Actual)

February 26, 2018

Last Update Submitted That Met QC Criteria

February 23, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC13_8911_CANARI

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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