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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)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
systematic biopsies
Targeted biopsies guided by a fusion of MRI and ultrasound- images
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prostate Cancer focused on measuring cancer, prostate, PSA, biopsies, ultrasound, MRI, fusion of images

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Grenoble
  • Chu Edouard Herriot
  • CHU Pitié salpêtrière
  • CHU Cochin
  • CHU Toulouse Rangueil
  • Clinique Pasteur

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Targeted biopsies guided by a fusion of MRI and ultrasound

Systematic biopsies

Arm Description

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

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

Outcomes

Primary Outcome Measures

Carcinomatous invasion on biopsies samples
The presence of carcinomatous invasion on biopsies samples

Secondary Outcome Measures

Tissue length of biopsy invaded by the detected cancer
Maximal tissue length of biopsy invaded by the detected cancer
Biopsy Gleason score of the detected cancer
Maximal biopsy Gleason score of the detected cancer
Respective duration of each biopsy protocol

Full Information

First Posted
January 29, 2014
Last Updated
March 13, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02050542
Brief Title
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.
Acronym
MURIELLE
Official Title
Comparison of Prostate Cancer Detection Rates Obtained With Multiparametric MRI Targeted Transrectal Ultrasound Biopsies and Systematic Transrectal Ultrasound Biopsies.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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 ®).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
cancer, prostate, PSA, biopsies, ultrasound, MRI, fusion of images

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Targeted biopsies guided by a fusion of MRI and ultrasound
Arm Type
Other
Arm Description
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
Arm Title
Systematic biopsies
Arm Type
Other
Arm Description
The patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate
Intervention Type
Procedure
Intervention Name(s)
systematic biopsies
Other Intervention Name(s)
Ultrasound-guided biopsies of the prostate
Intervention Description
90 patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate
Intervention Type
Procedure
Intervention Name(s)
Targeted biopsies guided by a fusion of MRI and ultrasound- images
Other Intervention Name(s)
Biopsies of the prostate by fusion of MRI and ultrasound- images with the Koelis ® system
Intervention Description
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
Primary Outcome Measure Information:
Title
Carcinomatous invasion on biopsies samples
Description
The presence of carcinomatous invasion on biopsies samples
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Tissue length of biopsy invaded by the detected cancer
Description
Maximal tissue length of biopsy invaded by the detected cancer
Time Frame
Day 15
Title
Biopsy Gleason score of the detected cancer
Description
Maximal biopsy Gleason score of the detected cancer
Time Frame
Day 15
Title
Respective duration of each biopsy protocol
Time Frame
Day 0

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Cornud, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Chu Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
CHU Pitié salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
CHU Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CHU Toulouse Rangueil
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France

12. IPD Sharing Statement

Learn more about this trial

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.

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