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

Last updated: February 27, 2024
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Prostate Disorders

Treatment

Blood sample

Follow up questionnaire

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

Clinical Study ID

NCT04732156
69HCL20_0769
  • Ages 18-80
  • Male

Study 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

Inclusion Criteria:

  • Men over 18 years of age
  • Patient with clinical suspicion of prostate cancer referred for a multiparametric MRIof the prostate before a first series of biopsies or before new biopsies after one ormore series of negative biopsies
  • PSA ≤ 30 ng / ml
  • Clinical stage ≤ T2c
  • Affiliation or beneficiary of a social security scheme

Exclusion

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 forthe 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 withan exclusion period still in progress
  • Misunderstanding of the French language

Study Design

Total Participants: 420
Treatment Group(s): 3
Primary Treatment: Blood sample
Phase:
Study Start date:
April 14, 2021
Estimated Completion Date:
June 15, 2026

Connect with a study center

  • Department of radiology and urology, CHU Pellegrin

    Bordeaux, 33076
    France

    Site Not Available

  • Department of urology and Radiology, CHU Grenoble Alpes

    Grenoble, 38043
    France

    Site Not Available

  • Department of radiology and urology, CHU de Lille

    Lille, 59037
    France

    Site Not Available

  • Department of radiology and urology, Hôpital Edouard Herriot

    Lyon, 69003
    France

    Active - Recruiting

  • Department of radiology and urology, Hôpital Saint Joseph Saint Luc

    Lyon, 69007
    France

    Site Not Available

  • Department of Radiology and Urology, Hopital Européen Marseille

    Marseille, 13003
    France

    Site Not Available

  • Department of Radiology and Urology, Institut Paoli-Calmettes Marseille

    Marseille, 13273
    France

    Site Not Available

  • Department of Urology, Clinique Beausoleil Montpellier

    Montpellier, 34070
    France

    Site Not Available

  • Department of urology and Radiology

    Montpellier, 34090
    France

    Site Not Available

  • Department Urology, Clinique urologique Nantes Atlantis

    Nantes, 44800
    France

    Site Not Available

  • Department of radiology and urology, Hôpital la Pitié Salpêtrière

    Paris, 75013
    France

    Site Not Available

  • Department of radiology, Hôpital Necker

    Paris, 75015
    France

    Site Not Available

  • Department of urology and radiology, CHLS

    Pierre-Bénite, 69310
    France

    Site Not Available

  • Department of Urology, Quint Fonsegrives

    Quint Fonsegrives, 31130
    France

    Site Not Available

  • Department of urology, CHU de Saint-Étienne Hôpital Nord

    Saint-Etienne, 42055
    France

    Site Not Available

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

    Strasbourg, 67000
    France

    Site Not Available

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

    Toulouse, 231059
    France

    Site Not Available

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