Status:
RECRUITING
Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
NA
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 specif...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2026
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT04732156
Start Date
April 14 2021
End Date
June 15 2026
Last Update
February 28 2024
Active Locations (17)
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1
Department of radiology and urology, CHU Pellegrin
Bordeaux, France, 33076
2
Department of urology and Radiology, CHU Grenoble Alpes
Grenoble, France, 38043
3
Department of radiology and urology, CHU de Lille
Lille, France, 59037
4
Department of radiology and urology, Hôpital Edouard Herriot
Lyon, France, 69003