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.

Study Overview
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Brief Summary
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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
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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 ®).

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: systematic biopsies
* Procedure: Targeted biopsies guided by a fusion of MRI and ultrasound- images


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Targeted biopsies guided by a fusion of MRI and ultrasound<br>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 | Procedure: systematic biopsies<br>* 90 patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate<br>* Other names: Ultrasound-guided biopsies of the prostate;Procedure: Targeted biopsies guided by a fusion of MRI and ultrasound- images<br>* 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<br>* Other names: Biopsies of the prostate by fusion of MRI and ultrasound- images with the Koelis ® system;|
| Other: Systematic biopsies<br>The patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate | Procedure: systematic biopsies<br>* 90 patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate<br>* Other names: Ultrasound-guided biopsies of the prostate;Procedure: Targeted biopsies guided by a fusion of MRI and ultrasound- images<br>* 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<br>* Other names: Biopsies of the prostate by fusion of MRI and ultrasound- images with the Koelis ® system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carcinomatous invasion on biopsies samples | The presence of carcinomatous invasion on biopsies samples | Day 15 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, prostate, PSA, biopsies, ultrasound, MRI, fusion of images