Clinical trial NCT02050542: 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.
Official title: Comparison of Prostate Cancer Detection Rates Obtained With Multiparametric MRI Targeted Transrectal Ultrasound Biopsies and Systematic Transrectal Ultrasound Biopsies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: cancer
prostate
PSA
biopsies
ultrasound
MRI
fusion of images
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 108
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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 ®).

Eligibility criteria: 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

Primary outcomes:
measure: Carcinomatous invasion on biopsies samples
timeFrame: Day 15
Secondary outcomes:
measure: Tissue length of biopsy invaded by the detected cancer
timeFrame: Day 15
measure: Biopsy Gleason score of the detected cancer
timeFrame: Day 15
measure: Respective duration of each biopsy protocol
timeFrame: Day 0
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble
city: Lyon
country: France
facility: Chu Edouard Herriot
city: Paris
country: France
facility: CHU Pitié salpêtrière
city: Paris
country: France
facility: CHU Cochin
city: Toulouse
country: France
facility: CHU Toulouse Rangueil
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: François Cornud, MD, PhD
role: STUDY_CHAIR
References: