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

About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate cancer, MRI, Artificial Intelligence, Computer-aided diagnosis system, Prostate biopsy
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
Sites / 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 HerriotRecruiting
- 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
Arms of the Study
Arm 1
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).