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.

Prostate Cancer Clinical Trial

— MURIELLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050542
• Other study ID #: 2013-A00514-41
• Secondary ID: SC 3065
• Status: Completed
• Phase: N/A
• First received: January 29, 2014
• Last updated: March 13, 2018
• Start date: June 2014
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• systematic biopsies
90 patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate
• Targeted biopsies guided by a fusion of MRI and ultrasound- images
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

Locations

Country	Name	City	State
France	CHU Grenoble	Grenoble
France	Chu Edouard Herriot	Lyon
France	CHU Cochin	Paris
France	CHU Pitié salpêtrière	Paris
France	CHU Toulouse Rangueil	Toulouse
France	Clinique Pasteur	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carcinomatous invasion on biopsies samples	The presence of carcinomatous invasion on biopsies samples	Day 15
Secondary	Tissue length of biopsy invaded by the detected cancer	Maximal tissue length of biopsy invaded by the detected cancer	Day 15
Secondary	Biopsy Gleason score of the detected cancer	Maximal biopsy Gleason score of the detected cancer	Day 15
Secondary	Respective duration of each biopsy protocol		Day 0