Clinical trial NCT04732156: Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System
Official title: Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
MRI
Artificial Intelligence
Computer-aided diagnosis system
Prostate biopsy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 420
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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

Primary outcomes:
measure: 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.
timeFrame: Through recruitment completion, an average of 2 years
Secondary outcomes:
measure: Comparison of the specificities of the CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers at per-patient, per-lobe and per-lesion analysis.
timeFrame: Through recruitment completion, an average of 2 years
measure: Comparison of the sensitivities of the CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers at per-patient, per-lobe and per-lesion analysis .
timeFrame: Through recruitment completion, an average of 2 years
measure: Comparison of the AUCs of the final CAD and of the PI-RADSv2.1 score for predicting the diagnosis of ISUP ≥2 cancer within 3 years, at per-patient analysis.
timeFrame: Through recruitment completion, an average of 2 years
measure: Comparison of the sensitivities and specificities of the final CAD and the PI-RADSv2.1 score for predicting the diagnosis of ISUP ≥2 cancer within 3 years, at per-patient analysis.
timeFrame: Through study completion, an average of 5 years
measure: Assessment of the impact of biopsy setting, magnetic field strength, human reader's experience, biopsy guidance technique and prostate volume on the AUC of the CAD and the PI-RADSv2.1 scores for the detection of ISUP cancers ≥2, at per-patient analysis.
timeFrame: Through recruitment completion, an average of 2 years
measure: Comparison of the AUC of the PHI index to that of the final CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers, at per-patient analysis.
timeFrame: Through recruitment completion, an average of 2 years
measure: Estimation of the number of biopsies avoided and the number of ISUP cancers ≥2 missed for the following diagnostic strategies:
timeFrame: Through recruitment completion, an average of 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Department of radiology and urology, CHU Pellegrin
city: Grenoble
country: France
facility: Department of urology and Radiology, CHU Grenoble Alpes
city: Lille
country: France
facility: Department of radiology and urology, CHU de Lille
city: Lyon
country: France
facility: Department of radiology and urology, Hôpital Edouard Herriot
city: Lyon
country: France
facility: Department of radiology and urology, Hôpital Saint Joseph Saint Luc
city: Marseille
country: France
facility: Department of Radiology and Urology, Hopital Européen Marseille
city: Marseille
country: France
facility: Department of Radiology and Urology, Institut Paoli-Calmettes Marseille
city: Montpellier
country: France
facility: Department of Urology, Clinique Beausoleil Montpellier
city: Montpellier
country: France
facility: Department of urology and Radiology
city: Nantes
country: France
facility: Department Urology, Clinique urologique Nantes Atlantis
city: Paris
country: France
facility: Department of radiology and urology, Hôpital la Pitié Salpêtrière
city: Paris
country: France
facility: Department of radiology, Hôpital Necker
city: Pierre-Bénite
country: France
facility: Department of urology and radiology, CHLS
city: Quint Fonsegrives
country: France
facility: Department of Urology, Quint Fonsegrives
city: Saint-Etienne
country: France
facility: Department of urology, CHU de Saint-Étienne Hôpital Nord
city: Strasbourg
country: France
facility: Department of Radiology and Urology, Nouvel Hôpital Civil - CHU de Strasbourg
city: Toulouse
country: France
facility: Department of Radiology adn Urology, Institut Universitaire du Cancer ,Toulouse
Study officials:
affiliation: Service d'imagerie, pavillon B Hôpital Edouard Herriot
name: Olivier ROUVIERE, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rouviere O, Souchon R, Lartizien C, Mansuy A, Magaud L, Colom M, Dubreuil-Chambardel M, Debeer S, Jaouen T, Duran A, Rippert P, Riche B, Monini C, Vlaeminck-Guillem V, Haesebaert J, Rabilloud M, Crouzet S. Detection of ISUP >/=2 prostate cancers using multiparametric MRI: prospective multicentre assessment of the non-inferiority of an artificial intelligence system as compared to the PI-RADS V.2.1 score (CHANGE study). BMJ Open. 2022 Feb 9;12(2):e051274. doi: 10.1136/bmjopen-2021-051274.