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.
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
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
108
90 patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate
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
CHU Grenoble
Grenoble, France
Chu Edouard Herriot
Lyon, France
CHU Pitié salpêtrière
Paris, France
CHU Cochin
Paris, France
CHU Toulouse Rangueil
Carcinomatous invasion on biopsies samples
The presence of carcinomatous invasion on biopsies samples
Time frame: Day 15
Tissue length of biopsy invaded by the detected cancer
Maximal tissue length of biopsy invaded by the detected cancer
Time frame: Day 15
Biopsy Gleason score of the detected cancer
Maximal biopsy Gleason score of the detected cancer
Time frame: Day 15
Respective duration of each biopsy protocol
Time frame: Day 0
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Toulouse, France
Clinique Pasteur
Toulouse, France