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

Civil Hospices of Lyon

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Other: Follow up questionnaire; Diagnostic Test: Human reading of prostate MR images (PI-RADSv2.1).; Biological: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT04732156

69HCL20_0769

Details and patient eligibility

About

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.

Enrollment: 420 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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420 participants in 1 patient group

Prospective multicenter cohort

Other group

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).

Treatment:

Biological: Blood sample

Diagnostic Test: Human reading of prostate MR images (PI-RADSv2.1).

Other: Follow up questionnaire