Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System
Trial ID: NCT04732156
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2021-04-14
Completion date: 2026-06-15
Sponsor: Hospices Civils de Lyon
Conditions: Prostate Cancer
Interventions: Blood sample; Follow up questionnaire; Human reading of prostate MR images (PI-RADSv2.1).
Locations: Department of radiology and urology, CHU Pellegrin; Department of urology and Radiology, CHU Grenoble Alpes; Department of radiology and urology, CHU de Lille; Department of radiology and urology, Hôpital Edouard Herriot; Department of radiology and urology, Hôpital Saint Joseph Saint Luc; Department of Radiology and Urology, Hopital Européen Marseille; Department of Radiology and Urology, Institut Paoli-Calmettes Marseille; Department of Urology, Clinique Beausoleil Montpellier; Department of urology and Radiology; Department Urology, Clinique urologique Nantes Atlantis; Department of radiology and urology, Hôpital la Pitié Salpêtrière; Department of radiology, Hôpital Necker; Department of urology and radiology, CHLS; Department of Urology, Quint Fonsegrives; Department of urology, CHU de Saint-Étienne Hôpital Nord; Department of Radiology and Urology, Nouvel Hôpital Civil - CHU de Strasbourg; Department of Radiology adn Urology, Institut Universitaire du Cancer ,Toulouse
Countries: France; France; France; France; France; France; France; France; France; France; France; France; France; France; France; France; France
Enrollment: 420
Age range: 18 Years - 80 Years
Sex: MALE

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 criteria:
Inclusion Criteria:

* 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

Exclusion Criteria:

* Men over 80 years of age
* PSA\> 30 ng / ml
* Stage T3 or T4 on digital rectal examination
* Previous prostate biopsy performed within 12 months
* History of prostate cancer diagnosed by biopsy or endourethral resection.
* History of pelvic radiotherapy regardless of the cause.
* History of total or focal treatment for prostate cancer.
* History of hormone therapy
* MRI performed more than 3 months before biopsy
* Prostate MRI performed on a machine other than the center's machines accredited for the study.
* Presence of a hip prosthesis
* Contraindication to performing an MRI
* Contraindication to performing prostate biopsy
* Patient subject to a legal protection measure or deprived of liberty
* Subject participating or having participated in interventional medical research with an exclusion period still in progress
* Misunderstanding of the French language

Outcomes:
Evaluation of the non-inferiority of the AUC of the final CAD developed in the PERFUSE program for the detection of ISUP ≥2 cancers, as compared to that of the PI-RADSv2.1 score (human reading), at per-patient analysis.