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

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Diagnostic test, Biological, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Men over 18 years of age

• Patient with clinical suspicion of prostate cancer referred for a multiparametric MRI of the prostate before a first series of biopsies or before new biopsies after one or more series of negative biopsies

• PSA ≤ 30 ng / ml

• Clinical stage ≤ T2c

• Affiliation or beneficiary of a social security scheme

Locations
Other Locations
France
Department of radiology and urology, CHU Pellegrin
NOT_YET_RECRUITING
Bordeaux
Department of urology and Radiology, CHU Grenoble Alpes
NOT_YET_RECRUITING
Grenoble
Department of radiology and urology, CHU de Lille
NOT_YET_RECRUITING
Lille
Department of radiology and urology, Hôpital Edouard Herriot
RECRUITING
Lyon
Department of radiology and urology, Hôpital Saint Joseph Saint Luc
NOT_YET_RECRUITING
Lyon
Department of Radiology and Urology, Hopital Européen Marseille
NOT_YET_RECRUITING
Marseille
Department of Radiology and Urology, Institut Paoli-Calmettes Marseille
NOT_YET_RECRUITING
Marseille
Department of urology and Radiology
NOT_YET_RECRUITING
Montpellier
Department of Urology, Clinique Beausoleil Montpellier
NOT_YET_RECRUITING
Montpellier
Department Urology, Clinique urologique Nantes Atlantis
NOT_YET_RECRUITING
Nantes
Department of radiology and urology, Hôpital la Pitié Salpêtrière
NOT_YET_RECRUITING
Paris
Department of radiology, Hôpital Necker
NOT_YET_RECRUITING
Paris
Department of urology and radiology, CHLS
NOT_YET_RECRUITING
Pierre-bénite
Department of Urology, Quint Fonsegrives
NOT_YET_RECRUITING
Quint-fonsegrives
Department of urology, CHU de Saint-Étienne Hôpital Nord
NOT_YET_RECRUITING
Saint-etienne
Department of Radiology and Urology, Nouvel Hôpital Civil - CHU de Strasbourg
NOT_YET_RECRUITING
Strasbourg
Department of Radiology adn Urology, Institut Universitaire du Cancer ,Toulouse
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Olivier ROUVIERE, Pr
olivier.rouviere@chu-lyon.fr
4 72 11 61 70
Backup
Adeline MANSUY, PhD
adeline.mansuy@chu-lyon.fr
4 72 11 51 70
Time Frame
Start Date: 2021-04-14
Estimated Completion Date: 2026-06-15
Participants
Target number of participants: 420
Treatments
Other: Prospective multicenter cohort
Constitution of a prospective multicenter cohort of 420 patients with suspected prostate cancer that will undergo prostate multiparametric MRI followed by systematic and targeted biopsy.~When available (i.e., at the end of the RHU PERFUSE program, November 2022), the final version of the CAD will be used retrospectively to assess the risk that the prostate/targeted lesions harbor ISUP ≥2 cancer.~In addition, a blood sample will be taken in all patients before the biopsy to assess the performance of the PHI index in predicting the presence of ISUP ≥2 cancer at systematic and targeted biopsy (ancillary study, secondary objective).
Related Therapeutic Areas
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov