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

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Biological: Blood sample
* Other: Follow up questionnaire
* Diagnostic Test: Human reading of prostate MR images (PI-RADSv2.1).


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Prospective multicenter cohort<br>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). | Biological: Blood sample<br>* Measurement of PHI Index<br>Other: Follow up questionnaire<br>* 3 years after inclusion<br>Diagnostic Test: Human reading of prostate MR images (PI-RADSv2.1).<br>* The PI-RADSv2.1 score will be compared to systematic and targeted biopsy findings (primary objective) and 3-year follow-up (secondary objective)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, MRI, Artificial Intelligence, Computer-aided diagnosis system, Prostate biopsy