Study of Current Practice Which Compare the Rate of Prostate Cancer by Using 2 Kind of Transrectal Biopsies: 3 by IRM-echography Image Fusion and 12 Systematized Guided Echographies. (MURIELLE)

March 13, 2018 updated by: Assistance Publique - Hôpitaux de Paris

Comparison of Prostate Cancer Detection Rates Obtained With Multiparametric MRI Targeted Transrectal Ultrasound Biopsies and Systematic Transrectal Ultrasound Biopsies.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The act of current practice evaluated by this research is the act of prostate biopsies : the patient will have to undergo 12 systematized transrectal echography guided biopsies of the prostate and 3 additional biopsies targeted on the suspicious lesion detected with MRI, which are both done in current practice.

  • A first operator is not informed of the location of the target. He will perform a series of 12 systematic transrectal ultrasound-guided biopsies of the prostate.
  • Immediately after the second operator will perform 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system

Act added by the research: Using a fusion of MRI - ultrasound images software system (Koelis ®).

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

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
      • Grenoble, France, 38043
        • CHU Grenoble
      • Lyon, France, 69437
        • Chu Edouard Herriot
      • Paris, France, 75014
        • CHU Cochin
      • Paris, France, 75013
        • CHU Pitié Salpétrière
      • Toulouse, France, 31076
        • Clinique Pasteur
      • Toulouse, France, 31076
        • CHU Toulouse Rangueil

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

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • patient from 45 to 75 years old;
  • Serum level of PSA > 4,0 ng / mL;
  • Multiparametric prostate IRM, performed before inclusion and which confirm the diagnosis of suspected target;
  • No opposition of the patient notified in the medical record
  • patient member in a national insurance scheme.

Exclusion Criteria:

  • 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

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

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Targeted biopsies guided by a fusion of MRI and ultrasound
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 biopsies
90 patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate
Other Names:
  • Ultrasound-guided biopsies of the prostate
Procedure: Targeted biopsies guided by a fusion of MRI and ultrasound- images
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
Other Names:
  • Biopsies of the prostate by fusion of MRI and ultrasound- images with the Koelis ® system
Other: Systematic biopsies
The patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate
Procedure: systematic biopsies
90 patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate
Other Names:
  • Ultrasound-guided biopsies of the prostate
Procedure: Targeted biopsies guided by a fusion of MRI and ultrasound- images
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
Other Names:
  • Biopsies of the prostate by fusion of MRI and ultrasound- images with the Koelis ® system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carcinomatous invasion on biopsies samples
Time Frame: Day 15
The presence of carcinomatous invasion on biopsies samples
Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue length of biopsy invaded by the detected cancer
Time Frame: Day 15
Maximal tissue length of biopsy invaded by the detected cancer
Day 15
Biopsy Gleason score of the detected cancer
Time Frame: Day 15
Maximal biopsy Gleason score of the detected cancer
Day 15
Respective duration of each biopsy protocol
Time Frame: Day 0
Day 0

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Chair: François Cornud, MD, PhD, Assistance Publique - Hôpitaux de Paris

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

June 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

January 29, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Actual)

March 15, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A00514-41
  • SC 3065 (Other Identifier: CPP)

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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