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

Prostate Cancer Clinical Trial

— CHANGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04732156
• Other study ID #: 69HCL20_0769
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: June 15, 2026

Study information

• Verified date: February 2024
• Source: Hospices Civils de Lyon
• Contact: Olivier ROUVIERE, Pr
• Phone: 4 72 11 61 70
• Email: olivier.rouviere[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: June 15, 2026
• Est. primary completion date: June 15, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• Blood sample
Measurement of PHI Index

Other:
• Follow up questionnaire
3 years after inclusion

Diagnostic Test:
• Human reading of prostate MR images (PI-RADSv2.1).
The PI-RADSv2.1 score will be compared to systematic and targeted biopsy findings (primary objective) and 3-year follow-up (secondary objective)

Locations

Country	Name	City	State
France	Department of radiology and urology, CHU Pellegrin	Bordeaux
France	Department of urology and Radiology, CHU Grenoble Alpes	Grenoble
France	Department of radiology and urology, CHU de Lille	Lille
France	Department of radiology and urology, Hôpital Edouard Herriot	Lyon
France	Department of radiology and urology, Hôpital Saint Joseph Saint Luc	Lyon
France	Department of Radiology and Urology, Hopital Européen Marseille	Marseille
France	Department of Radiology and Urology, Institut Paoli-Calmettes Marseille	Marseille
France	Department of urology and Radiology	Montpellier
France	Department of Urology, Clinique Beausoleil Montpellier	Montpellier
France	Department Urology, Clinique urologique Nantes Atlantis	Nantes
France	Department of radiology and urology, Hôpital la Pitié Salpêtrière	Paris
France	Department of radiology, Hôpital Necker	Paris
France	Department of urology and radiology, CHLS	Pierre-Bénite
France	Department of Urology, Quint Fonsegrives	Quint Fonsegrives
France	Department of urology, CHU de Saint-Étienne Hôpital Nord	Saint-Etienne
France	Department of Radiology and Urology, Nouvel Hôpital Civil - CHU de Strasbourg	Strasbourg
France	Department of Radiology adn Urology, Institut Universitaire du Cancer ,Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Specificity of the final CAD and of the PI-RADSv2.1 score for the detection of ISUP =2 cancers on systematic and targeted biopsies performed after MRI (per-patient, per-lobe and per-lesion analysis).	Through recruitment completion, an average of 2 years
Secondary	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 .	Sensitivity of the final CAD and of the PI-RADSv2.1 score for the detection of ISUP =2 cancers on systematic and targeted biopsies performed after MRI (per-patient, per-lobe and per-lesion analysis)	Through recruitment completion, an average of 2 years
Secondary	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.	AUC of the final CAD and the PI-RADSv2.1 score for predicting the diagnosis of ISUP =2 cancer within 3 years of follow-up, at per-patient analysis.	Through recruitment completion, an average of 2 years
Secondary	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.	Sensitivity and specificity of the final CAD and the PI-RADSv2.1 score for predicting the diagnosis of ISUP =2 cancer within 3 years of follow-up, at per-patient analysis.	Through study completion, an average of 5 years
Secondary	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.	Analysis of the effect of biopsy setting, magnetic field strength, reader's experience, biopsy guidance technique and prostate volume on the AUC of the final CAD and the PI-RADv2.1, at per-patient analysis.	Through recruitment completion, an average of 2 years
Secondary	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.	AUC of the PHI index for the detection of cancers ISUP =2 on systematic and targeted biopsies performed after MRI, at per-patient analysis.	Through recruitment completion, an average of 2 years
Secondary	Estimation of the number of biopsies avoided and the number of ISUP cancers =2 missed for the following diagnostic strategies:	Number of biopsies avoided and number of ISUP cancers =2 missed according to the strategies described below: PHI index then, if positive, MRI and biopsies regardless of the MRI result (MRI used only to guide targeted biopsies).; PHI index then, if positive, MRI then, if positive, targeted biopsies.; Biopsy only if MRI positive; no PHI index.; MRI then, if positive, PHI index then, if positive, targeted biopsies.; MRI then, if negative, PHI index; biopsy for patients with a positive MRI or with a negative MRI but a positive PHI index; PHI index and MRI for all patients; biopsy if positive PHI index AND positive MRI.; PHI index and MRI for all patients; biopsy if positive PHI OR positive MRI.	Through recruitment completion, an average of 2 years