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Completed

NCT Number: NCT02050542

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.

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.

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Key information

Age range

45 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CHU Grenoble, Grenoble, France

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About this study

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 ®).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

systematic biopsies

Procedure

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

Other names: Ultrasound-guided biopsies of the prostate

Targeted biopsies guided by a fusion of MRI and ultrasound- images

Procedure

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

Primary outcomes

  1. Carcinomatous invasion on biopsies samples

    Time frame: Day 15

    The presence of carcinomatous invasion on biopsies samples

Secondary outcomes

  1. Tissue length of biopsy invaded by the detected cancer

    Time frame: Day 15

    Maximal tissue length of biopsy invaded by the detected cancer

  2. Biopsy Gleason score of the detected cancer

    Time frame: Day 15

    Maximal biopsy Gleason score of the detected cancer

  3. Respective duration of each biopsy protocol

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: MURIELLE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 30, 2014
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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