AI detection of prostate cancer using MRI
Automatic Detection in MRI of Prostate Cancer: DAICAP
This study is testing a new artificial intelligence tool that uses MRI scans to help doctors find and understand prostate cancer better in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1250 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05513820 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and test an artificial intelligence algorithm for the detection and characterization of prostate cancer using multiparametric MRI images. It involves a multicentric approach, combining a retrospective analysis of 700 patients' historical data for training and validation, followed by a prospective analysis of 550 patients to test the algorithm's performance. The study will correlate MRI findings with histological and biological data to enhance diagnostic accuracy and predict tumor aggressiveness.
Who should consider this trial
Good fit: Ideal candidates include patients with clinical suspicion of prostate cancer, indicated by elevated PSA levels or abnormalities detected during a digital rectal examination.
Not a fit: Patients with a confirmed diagnosis of prostate cancer or those who have received prior treatment for prostate cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the accuracy of prostate cancer diagnosis and reduce unnecessary biopsies.
How similar studies have performed: Other studies utilizing AI for cancer detection in imaging have shown promising results, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Retrospective substudy Inclusion Criteria: * Patients with clinical suspicion of prostate cancer (increased PSA and/or abnormality on digital rectal examination) who underwent a diagnostic workup including mpMRI and prostate biopsies according to national recommendations: in case of normal mpMRI (PI-RADS \< 3) 12 systematic samples; in case of pathological mpMRI (PI-RADS ≥3) 12 systematic samples associated with targeted samples (n= 2 to 4) by cognitive fusion, or image fusion software. Exclusion Criteria: * Patients with histologically proven prostate cancer and/or treatment for prostate cancer prior to the diagnostic workup Prospective substudy Inclusion Criteria: * Patients with clinical suspicion of prostate cancer (increased PSA level and/or abnormality on digital rectal examination) who should receive a diagnostic workup including mpMRI and prostate biopsies according to national recommendations: in case of normal mpMRI (PI-RADS \< 3) 12 systematic samples; in case of pathological mpMRI (PI-RADS ≥3) 12 systematic samples associated with targeted samples (n= 2 to 4) by cognitive fusion, or image fusion software. Exclusion Criteria: * Patients with already histologically proven cancer, patients who have received treatment for prostate cancer, patients who cannot benefit from prostate biopsies, or patients with a contraindication to performing mpMRI.
Where this trial is running
Paris
- La Pitié Salpétrière Hospital — Paris, France (Recruiting)
Study contacts
- Study coordinator: Raphaële Renard-Penna, MD, PhD
- Email: Raphaele.renardpenna@aphp.fr
- Phone: 01 42 17 82 25
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.