Clinical trial · Interventional
Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Biological | — | UNRESOLVED |
| Follow up questionnaire | Other | — | UNRESOLVED |
| Human reading of prostate MR images (PI-RADSv2.1). | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Prospective multicenter cohort
- description
- 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).
- interventionNames
- Biological: Blood sample
- Other: Follow up questionnaire
- Diagnostic Test: Human reading of prostate MR images (PI-RADSv2.1).
Primary outcomes (1)
- 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
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRouviere 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 35140147