Automatic Detection in MRI of Prostate Cancer: DAICAP

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Prostate cancer is the most common cancer in France and the 3rd most common cancer death in humans. The introduction of pre-biopsy MRI has considerably improved the quality of prostate cancer (PCa) diagnosis by increasing the detection of clinically significant PCa , and by reducing the number of unnecessary biopsies.However the diagnostic performance of Prostate MRI is highly dependent on reader experience that limits the population based delivery of high quality multiparametricMRI (mpMRI) driven PCa diagnosis. The main objective of this study is the development and the test of diagnostic accuracy of an AI algorithm for the detection of cancerous prostatic lesions from mpMRI images. The secondary objective is the development and the test of diagnostic accuracy of an AI algorithm to predict tumor aggressiveness from mpMRI images.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
Other Locations
France
La Pitié Salpétrière Hospital
RECRUITING
Paris
Contact Information
Primary
Raphaële Renard-Penna, MD, PhD
Raphaele.renardpenna@aphp.fr
01 42 17 82 25
Time Frame
Start Date: 2022-06-21
Estimated Completion Date: 2024-12
Participants
Target number of participants: 1250
Treatments
Retrospective group
Retrospective group: 700 patients from the databases of the AP-HP, the Lyon University Hospital and the Lille University Hospital for training and validation of the algorithms.
Prospective group
Prospective group: 550 patients (test-set) from AP-HP (CHU Pitié, Tenon, Bicêtre, Necker), CHU Lille, CHU Lyon, CHU Bordeaux and CHU Strasbourg to tes the performance of the algorithms.
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital, Strasbourg, France, The Civil Hospitals, Lyon, Institut National de Recherche en Informatique et en Automatique, INCEPTO, University Hospital, Bordeaux, University Hospital, Lille
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov