Using MRI and AI to detect significant prostate cancers
Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System
NA · Hospices Civils de Lyon · NCT04732156
This study is testing a new artificial intelligence system to see if it can better detect significant prostate cancers in patients suspected of having the disease compared to the current MRI scoring method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Hospices Civils de Lyon (other) |
| Locations | 17 sites (Bordeaux and 16 other locations) |
| Trial ID | NCT04732156 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the detection of significant prostate cancers (ISUP ≥2) by comparing the effectiveness of the PI-RADS score with a newly developed artificial intelligence system. Patients suspected of having prostate cancer will undergo multiparametric MRI followed by targeted biopsies. The study will create a multicenter cohort to evaluate the performance of the AI system across different MRI machines and institutions, addressing the challenge of variability in MRI image quality. The goal is to enhance diagnostic accuracy and reduce unnecessary biopsies.
Who should consider this trial
Good fit: Ideal candidates for this study are men over 18 years old with a clinical suspicion of prostate cancer who are scheduled for a multiparametric MRI before their first or subsequent biopsies.
Not a fit: Patients who have previously been diagnosed with prostate cancer or have had recent biopsies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate detection of significant prostate cancers, potentially reducing the number of unnecessary biopsies and improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using AI for medical imaging, but this specific approach of combining AI with multiparametric MRI for prostate cancer detection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bordeaux and 16 other locations
- Department of radiology and urology, CHU Pellegrin — Bordeaux, France (NOT_YET_RECRUITING)
- Department of urology and Radiology, CHU Grenoble Alpes — Grenoble, France (NOT_YET_RECRUITING)
- Department of radiology and urology, CHU de Lille — Lille, France (NOT_YET_RECRUITING)
- Department of radiology and urology, Hôpital Edouard Herriot — Lyon, France (RECRUITING)
- Department of radiology and urology, Hôpital Saint Joseph Saint Luc — Lyon, France (NOT_YET_RECRUITING)
- Department of Radiology and Urology, Hopital Européen Marseille — Marseille, France (NOT_YET_RECRUITING)
- Department of Radiology and Urology, Institut Paoli-Calmettes Marseille — Marseille, France (NOT_YET_RECRUITING)
- Department of Urology, Clinique Beausoleil Montpellier — Montpellier, France (NOT_YET_RECRUITING)
- Department of urology and Radiology — Montpellier, France (NOT_YET_RECRUITING)
- Department Urology, Clinique urologique Nantes Atlantis — Nantes, France (NOT_YET_RECRUITING)
- Department of radiology and urology, Hôpital la Pitié Salpêtrière — Paris, France (NOT_YET_RECRUITING)
- Department of radiology, Hôpital Necker — Paris, France (NOT_YET_RECRUITING)
- Department of urology and radiology, CHLS — Pierre-Bénite, France (NOT_YET_RECRUITING)
- Department of Urology, Quint Fonsegrives — Quint-Fonsegrives, France (NOT_YET_RECRUITING)
- Department of urology, CHU de Saint-Étienne Hôpital Nord — Saint-Etienne, France (NOT_YET_RECRUITING)
- Department of Radiology and Urology, Nouvel Hôpital Civil - CHU de Strasbourg — Strasbourg, France (NOT_YET_RECRUITING)
- Department of Radiology adn Urology, Institut Universitaire du Cancer ,Toulouse — Toulouse, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Olivier ROUVIERE, Pr — Service d'imagerie, pavillon B Hôpital Edouard Herriot
- Study coordinator: Olivier ROUVIERE, Pr
- Email: olivier.rouviere@chu-lyon.fr
- Phone: 4 72 11 61 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, prostate cancer, MRI, Artificial Intelligence, Computer-aided diagnosis system, Prostate biopsy