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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
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
Blood sample
Measurement of PHI Index
Follow up questionnaire
3 years after inclusion
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