NCT02873117

Brief Summary

This is a multicenter, cohort study based on medico-administrative data from pathology laboratory registries and drug reimbursement files (CNAM-TS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,154

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

2.1 years

First QC Date

August 16, 2016

Last Update Submit

February 23, 2018

Conditions

Benign Prostate Hyperplasia

Keywords

Benign prostate hyperplasia5 alpha reductase inhibitorprostate cancerSymptomatictreated

Outcome Measures

Primary Outcomes (1)

  • High grade (Gleason >= 7) prostate cancer

    Day 1

Study Arms (2)

5 alpha reductase inhibitor

Other: Prostate biopsy, prostatectomy or prostate resection

Any other drug for benign prostate hyperplasia

Other: Prostate biopsy, prostatectomy or prostate resection

Interventions

Prostate biopsy, prostatectomy or prostate resectionOTHER

Collection of prostate examination

5 alpha reductase inhibitorAny other drug for benign prostate hyperplasia

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Men treated for benign prostate hyperplasia

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

Prostatic HyperplasiaProstatic Neoplasms

Interventions

Prostatectomy

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 19, 2016

Study Start

December 1, 2014

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

February 26, 2018

Record last verified: 2018-02

Locations

FR(1)