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.
- Conditions
- Prostate Cancer
- Interventions
- Procedure: systematic biopsiesProcedure: Targeted biopsies guided by a fusion of MRI and ultrasound- images
- Registration Number
- NCT02050542
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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 ®).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 108
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Targeted biopsies guided by a fusion of MRI and ultrasound systematic biopsies 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 Targeted biopsies guided by a fusion of MRI and ultrasound Targeted biopsies guided by a fusion of MRI and ultrasound- images 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 Systematic biopsies systematic biopsies The patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate Systematic biopsies Targeted biopsies guided by a fusion of MRI and ultrasound- images The patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate
- Primary Outcome Measures
Name Time Method Carcinomatous invasion on biopsies samples Day 15 The presence of carcinomatous invasion on biopsies samples
- Secondary Outcome Measures
Name Time Method Respective duration of each biopsy protocol Day 0 Biopsy Gleason score of the detected cancer Day 15 Maximal biopsy Gleason score of the detected cancer
Tissue length of biopsy invaded by the detected cancer Day 15 Maximal tissue length of biopsy invaded by the detected cancer
Trial Locations
- Locations (6)
CHU Cochin
🇫🇷Paris, France
CHU Grenoble
🇫🇷Grenoble, France
CHU Pitié salpêtrière
🇫🇷Paris, France
Chu Edouard Herriot
🇫🇷Lyon, France
CHU Toulouse Rangueil
🇫🇷Toulouse, France
Clinique Pasteur
🇫🇷Toulouse, France