Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System
CHANGE
1 other identifier
interventional
420
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Apr 2021
Typical duration for not_applicable prostate-cancer
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2021
CompletedFirst Posted
Study publicly available on registry
February 1, 2021
CompletedStudy Start
First participant enrolled
April 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 15, 2026
February 28, 2024
February 1, 2024
5.2 years
January 18, 2021
February 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
AUC of the final CAD and of the PI-RADS version 2.1 score for the detection of ISUP ≥2 cancers on systematic and targeted biopsies performed after MRI, at per-patient analysis. A priori-defined non-inferiority margin: 5 percentage points.
Through recruitment completion, an average of 2 years
Secondary Outcomes (7)
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.
Through recruitment completion, an average of 2 years
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 .
Through recruitment completion, an average of 2 years
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.
Through recruitment completion, an average of 2 years
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.
Through study completion, an average of 5 years
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.
Through recruitment completion, an average of 2 years
- +2 more secondary outcomes
Study Arms (1)
Prospective multicenter cohort
OTHERConstitution 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).
Interventions
The PI-RADSv2.1 score will be compared to systematic and targeted biopsy findings (primary objective) and 3-year follow-up (secondary objective)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Misunderstanding of the French language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Department of radiology and urology, CHU Pellegrin
Bordeaux, 33076, France
Department of urology and Radiology, CHU Grenoble Alpes
Grenoble, 38043, France
Department of radiology and urology, CHU de Lille
Lille, 59037, France
Department of radiology and urology, Hôpital Edouard Herriot
Lyon, 69003, France
Department of radiology and urology, Hôpital Saint Joseph Saint Luc
Lyon, 69007, France
Department of Radiology and Urology, Hopital Européen Marseille
Marseille, 13003, France
Department of Radiology and Urology, Institut Paoli-Calmettes Marseille
Marseille, 13273, France
Department of Urology, Clinique Beausoleil Montpellier
Montpellier, 34070, France
Department of urology and Radiology
Montpellier, 34090, France
Department Urology, Clinique urologique Nantes Atlantis
Nantes, 44800, France
Department of radiology and urology, Hôpital la Pitié Salpêtrière
Paris, 75013, France
Department of radiology, Hôpital Necker
Paris, 75015, France
Department of urology and radiology, CHLS
Pierre-Bénite, 69310, France
Department of Urology, Quint Fonsegrives
Quint-Fonsegrives, 31130, France
Department of urology, CHU de Saint-Étienne Hôpital Nord
Saint-Etienne, 42055, France
Department of Radiology and Urology, Nouvel Hôpital Civil - CHU de Strasbourg
Strasbourg, 67000, France
Department of Radiology adn Urology, Institut Universitaire du Cancer ,Toulouse
Toulouse, 231059, France
Related Publications (1)
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.
PMID: 35140147DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier ROUVIERE, Pr
Service d'imagerie, pavillon B Hôpital Edouard Herriot
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2021
First Posted
February 1, 2021
Study Start
April 14, 2021
Primary Completion (Estimated)
June 15, 2026
Study Completion (Estimated)
June 15, 2026
Last Updated
February 28, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
After publication of the results of the trial, the CHANGE cohort will be made partially accessible to other investigators wishing to test a CAD system aimed at detecting/localizing prostate cancer on MR images while respecting patient information. Request for access to pseudonymized data will be reviewed by the Trial Steering Committee that will grant access or not. To gain access, requestors will be required to sign a data access agreement. Of note, investigators will have access only to the MR images and not to the histological findings. After analysis of the CHANGE MR images by their CAD system, the investigator will be requested to send the results to the Hospices Civils de Lyon. The comparison between the CAD findings and the targeted and systematic biopsy findings will be made by the Hospices Civils de Lyon that will then inform the investigator of the CAD diagnostic performance.