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RECRUITING
NCT04732156
NA

Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

Summary

Multiparametric MRI of the prostate is recommended before each prostate biopsy. It identifies suspicious areas which will then be the subject of targeted biopsies. However, MRI suffers from low specificity and moderate inter-reader reproducibility, including with the use of the PI-RADS version 2.1 score. We are developing, within the framework of RHU PERFUSE, a computer-aided diagnosis system (CAD) for the detection of ISUP ≥2 cancers. This system has been trained on a database of patients who had prostate MRI and prostatectomy at the Hospices Civils de Lyon and performed well on a database of patients who had prostate MRI before biopsy at the Hopices civils de Lyon. However, one of the weaknesses of artificial intelligence systems is their low robustness when tested on MRI images from different manufacturers or institutions. The goal of the CHANGE study is to build a prospective multicenter cohort of patients who underwent prostate multiparametric MRI followed by systematic and targeted prostate biopsies. The cohort will be used for the final external validation of the CAD developed in PERFUSE.

Key Details

Gender

MALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

420

Start Date

2021-04-14

Completion Date

2026-06-15

Last Updated

2024-02-28

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Blood sample

Measurement of PHI Index

OTHER

Follow up questionnaire

3 years after inclusion

DIAGNOSTIC_TEST

Human reading of prostate MR images (PI-RADSv2.1).

The PI-RADSv2.1 score will be compared to systematic and targeted biopsy findings (primary objective) and 3-year follow-up (secondary objective)

Locations (17)

Department of radiology and urology, CHU Pellegrin

Bordeaux, France

Department of urology and Radiology, CHU Grenoble Alpes

Grenoble, France

Department of radiology and urology, CHU de Lille

Lille, France

Department of radiology and urology, Hôpital Edouard Herriot

Lyon, France

Department of radiology and urology, Hôpital Saint Joseph Saint Luc

Lyon, France

Department of Radiology and Urology, Hopital Européen Marseille

Marseille, France

Department of Radiology and Urology, Institut Paoli-Calmettes Marseille

Marseille, France

Department of Urology, Clinique Beausoleil Montpellier

Montpellier, France

Department of urology and Radiology

Montpellier, France

Department Urology, Clinique urologique Nantes Atlantis

Nantes, France

Department of radiology and urology, Hôpital la Pitié Salpêtrière

Paris, France

Department of radiology, Hôpital Necker

Paris, France

Department of urology and radiology, CHLS

Pierre-Bénite, France

Department of Urology, Quint Fonsegrives

Quint-Fonsegrives, France

Department of urology, CHU de Saint-Étienne Hôpital Nord

Saint-Etienne, France

Department of Radiology and Urology, Nouvel Hôpital Civil - CHU de Strasbourg

Strasbourg, France

Department of Radiology adn Urology, Institut Universitaire du Cancer ,Toulouse

Toulouse, France