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)
November 17, 2025 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
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
-
-
-
Grenoble, France, 38043
- CHU Grenoble
-
Lyon, France, 69437
- Chu Edouard Herriot
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Paris, France, 75014
- CHU Cochin
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Paris, France, 75013
- CHU Pitie Salpetriere
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Toulouse, France, 31076
- Clinique Pasteur
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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
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
|
90 patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate
Other Names:
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:
|
|
Other: Systematic biopsies
The patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate
|
90 patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate
Other Names:
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:
|
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.
Collaborators
Investigators
- Study Chair: François Cornud, MD, PhD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Estimated)
January 30, 2014
Study Record Updates
Last Update Posted (Actual)
November 20, 2025
Last Update Submitted That Met QC Criteria
November 17, 2025
Last Verified
November 1, 2025
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.