NCT04692207

Brief Summary

Our objective is to search for clinical, biological and imaging element that would better define the patient population that could benefit from targeted prostate biopsies only (from a cohort of patients who had targeted and non-targeted prostate biopsies).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

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

June 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

2.9 years

First QC Date

December 28, 2020

Last Update Submit

December 31, 2020

Conditions

Prostate Cancer

Keywords

Targeted prostate biopsyNon-targeted prostate biopsyMRIprostatebiopsy

Outcome Measures

Primary Outcomes (1)

  • Non-targeted biopsy not finding cancer of finding cancer of a grade lower than or egal to that found on targeted biopsies

    Non-targeted biopsy not finding cancer of finding cancer of a grade lower than or egal to that found on targeted biopsies

    1 month

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who had a prostate MRI between June 2017 and March 2020 for suspected cancer, followed by targeted and non-targeted prostate biopsies (12) at the Montpellier University Hospital

You may qualify if:

  • Age \> or = at 18 years old
  • Prostatic MRI performed at the Montpellier University Hospital
  • Realization of targeted prostate biopsies (by fusion of MRI - ultrasound images) and non-targeted biopsies

You may not qualify if:

  • Pre-biopsy MRI performed outside of the Montpellier University Hospital
  • MRI with artefacts
  • Not performing 12 non-targeted prostate biopsies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Ingrid Millet, PUPH

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 28, 2020

First Posted

December 31, 2020

Study Start

June 1, 2017

Primary Completion

May 1, 2020

Study Completion

October 30, 2020

Last Updated

January 5, 2021

Record last verified: 2020-12

Locations

FR(1)