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)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Prostate Cancer

Treatments

Procedure: systematic biopsies

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02050542

SC 3065 (Other Identifier)

2013-A00514-41

Details and patient eligibility

About

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.

Full 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 ®).

Enrollment

108 patients

Sex

Male

Ages

45 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

108 participants in 2 patient groups

Targeted biopsies guided by a fusion of MRI and ultrasound

Other group

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

Treatment:

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

Procedure: systematic biopsies

Systematic biopsies

Other group

Description:

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

Treatment:

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

Procedure: systematic biopsies