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.

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02050542

Acronym

MURIELLE

Enrollment

108

Registered

2014-01-30

Start date

2014-06-30

Completion date

2015-02-28

Last updated

2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

cancer, prostate, PSA, biopsies, ultrasound, MRI, fusion of images

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 ®).

Interventions

PROCEDUREsystematic biopsies

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

PROCEDURETargeted 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

45 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Carcinomatous invasion on biopsies samples	Day 15	The presence of carcinomatous invasion on biopsies samples

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026