CompletedNot Applicable

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.

France108 participantsStarted 2014-06

Plain-language 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.

Who can participate

Age range45 Years – 75 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Carcinomatous invasion on biopsies samples

Timeframe: Day 15

Trial details

NCT IDNCT02050542

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-01

View on ClinicalTrials.gov More Prostate Cancer trials