Prostate Biopsies With Target Lesion on MRI

Prostate Biopsies With Target Lesion on MRI : When Can Non-targeted Biopsies be Dispensed With

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).

Study Overview

• Status: Completed
• Conditions: Prostate Cancer

• Study Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability 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

Description

Inclusion criteria:

• 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

Exclusion criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Ingrid Millet, PUPH, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 31, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: MRI; prostate; biopsy; Targeted prostate biopsy; Non-targeted prostate biopsy
• Additional Relevant MeSH Terms: Skin Diseases; Erythema; Skin Diseases, Vesiculobullous; Erythema Multiforme
• Other Study ID Numbers: RECHMPL20_0684

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No