Actively Recruiting
Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System
Led by Hospices Civils de Lyon · Updated on 2024-02-28
420
Participants Needed
17
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men over 18 years of age
- Clinical suspicion of prostate cancer referred for multiparametric MRI before first or repeat biopsies
- PSA level 30 ng/ml or lower
- Clinical stage T2c or lower
- Affiliated with or beneficiary of a social security scheme
You will not qualify if you...
- Men over 80 years of age
- PSA level above 30 ng/ml
- Clinical stage T3 or T4 on digital rectal examination
- Prostate biopsy performed within the previous 12 months
- History of prostate cancer diagnosed by biopsy or endourethral resection
- History of pelvic radiotherapy
- 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 non-accredited machine
- Presence of a hip prosthesis
- Contraindications to MRI or prostate biopsy
- Subject under legal protection or deprived of liberty
- Participation in other interventional medical research with ongoing exclusion period
- Inability to understand the French language
AI-Screening
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Trial Site Locations
Total: 17 locations
1
Department of radiology and urology, CHU Pellegrin
Bordeaux, France, 33076
Not Yet Recruiting
2
Department of urology and Radiology, CHU Grenoble Alpes
Grenoble, France, 38043
Not Yet Recruiting
3
Department of radiology and urology, CHU de Lille
Lille, France, 59037
Not Yet Recruiting
4
Department of radiology and urology, Hôpital Edouard Herriot
Lyon, France, 69003
Actively Recruiting
5
Department of radiology and urology, Hôpital Saint Joseph Saint Luc
Lyon, France, 69007
Not Yet Recruiting
6
Department of Radiology and Urology, Hopital Européen Marseille
Marseille, France, 13003
Not Yet Recruiting
7
Department of Radiology and Urology, Institut Paoli-Calmettes Marseille
Marseille, France, 13273
Not Yet Recruiting
8
Department of Urology, Clinique Beausoleil Montpellier
Montpellier, France, 34070
Not Yet Recruiting
9
Department of urology and Radiology
Montpellier, France, 34090
Not Yet Recruiting
10
Department Urology, Clinique urologique Nantes Atlantis
Nantes, France, 44800
Not Yet Recruiting
11
Department of radiology and urology, Hôpital la Pitié Salpêtrière
Paris, France, 75013
Not Yet Recruiting
12
Department of radiology, Hôpital Necker
Paris, France, 75015
Not Yet Recruiting
13
Department of urology and radiology, CHLS
Pierre-Bénite, France, 69310
Not Yet Recruiting
14
Department of Urology, Quint Fonsegrives
Quint-Fonsegrives, France, 31130
Not Yet Recruiting
15
Department of urology, CHU de Saint-Étienne Hôpital Nord
Saint-Etienne, France, 42055
Not Yet Recruiting
16
Department of Radiology and Urology, Nouvel Hôpital Civil - CHU de Strasbourg
Strasbourg, France, 67000
Not Yet Recruiting
17
Department of Radiology adn Urology, Institut Universitaire du Cancer ,Toulouse
Toulouse, France, 231059
Not Yet Recruiting
Research Team
O
Olivier ROUVIERE, Pr
CONTACT
A
Adeline MANSUY, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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