NCT02050542

Brief Summary

The purpose of the study is to show that 3 targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system, will get no lower rate of cancer detection than those obtained by 12 systematic transrectal ultrasound-guided biopsies of the prostate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

6 active sites

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

First Submitted

Initial submission to the registry

January 29, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

January 29, 2014

Last Update Submit

November 17, 2025

Conditions

Prostate Cancer

Keywords

cancerprostatePSAbiopsiesultrasoundMRIfusion of images

Outcome Measures

Primary Outcomes (1)

  • Carcinomatous invasion on biopsies samples

    The presence of carcinomatous invasion on biopsies samples

    Day 15

Secondary Outcomes (3)

  • Tissue length of biopsy invaded by the detected cancer

    Day 15

  • Biopsy Gleason score of the detected cancer

    Day 15

  • Respective duration of each biopsy protocol

    Day 0

Study Arms (2)

Targeted biopsies guided by a fusion of MRI and ultrasound

OTHER

After the 12 systematic biopsies, the same patients will have to undergo 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system

Procedure: systematic biopsiesProcedure: Targeted biopsies guided by a fusion of MRI and ultrasound- images

Systematic biopsies

OTHER

The patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate

Procedure: systematic biopsiesProcedure: Targeted biopsies guided by a fusion of MRI and ultrasound- images

Interventions

systematic biopsiesPROCEDURE

90 patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate

Also known as: Ultrasound-guided biopsies of the prostate
Systematic biopsiesTargeted biopsies guided by a fusion of MRI and ultrasound
Targeted biopsies guided by a fusion of MRI and ultrasound- imagesPROCEDURE

Immediately after the 12 systematic biopsies, the same patients will have to undergo 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system

Also known as: Biopsies of the prostate by fusion of MRI and ultrasound- images with the Koelis ® system
Systematic biopsiesTargeted biopsies guided by a fusion of MRI and ultrasound

Eligibility Criteria

Age45 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient from 45 to 75 years old;
  • Serum level of PSA \> 4,0 ng / mL;
  • No opposition of the patient notified in the medical record
  • patient member in a national insurance scheme.

You may not qualify if:

  • Previous prostate biopsy;
  • suspicious digital rectal examination;
  • serum PSA \> 20,0 ng / mL;
  • treatment with 5 alpha reductase inhibitor during the last 3 months;
  • untreated urinary infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU Grenoble

Grenoble, 38043, France

Location

Chu Edouard Herriot

Lyon, 69437, France

Location

CHU Pitié salpêtrière

Paris, 75013, France

Location

CHU Cochin

Paris, 75014, France

Location

CHU Toulouse Rangueil

Toulouse, 31076, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Related Publications (1)

  • Delongchamps NB, Portalez D, Bruguiere E, Rouviere O, Malavaud B, Mozer P, Fiard G, Cornud F; MURIELLE Study Group. Are Magnetic Resonance Imaging-Transrectal Ultrasound Guided Targeted Biopsies Noninferior to Transrectal Ultrasound Guided Systematic Biopsies for the Detection of Prostate Cancer? J Urol. 2016 Oct;196(4):1069-75. doi: 10.1016/j.juro.2016.04.003. Epub 2016 Apr 12.

    PMID: 27079582RESULT

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • François Cornud, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2014

First Posted

January 30, 2014

Study Start

June 1, 2014

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

November 20, 2025

Record last verified: 2025-11

Locations

FR(6)