To hear about similar clinical trials, please enter your email below
Trial Title:
Automatic Detection in MRI of Prostate Cancer: DAICAP
NCT ID:
NCT05513820
Condition:
Detection and Characterization of Prostate Cancer Based on Artificial Intelligence
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate Cancer
PI-RADS
PSA
Artificial Intelligence
Multiparametric Magnetic Resonance Imaging
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
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.
Detailed description:
This is a study combining :
1. Firstly a sub-study with a multicentric retrospective sample of 700 patients from
the databases of AP-HP, CHU de Lyon and CHU de Lille for training and validation of
algorithms. The historical depth may be up to 96 months (8 years)
2. A second sub-study with a multicentric prospective sample of 550 patients (test-set)
associating AP-HP (CHU Pitié, Tenon, Bicêtre, Necker), CHU Lille, CHU Lyon, CHU
Bordeaux and CHU Strasbourg to test the performance of algorithms Data will be
collected retrospectively (training phase - validation of the algorithm) and
prospectively (testing phase of the algorithm) from the medical records of each of
the centres for patients corresponding to the inclusion and exclusion criteria
mentioned above.
Methodology :
1. Retrospective phase mpMRI images chained to histological (prostate biopsy data),
biological (PSA) and demographic (age) data will be used for supervised learning
during the training and validation phases. Thus, the aggressiveness scores will rely
on a matching between mpMRI images and the results of targeted biopsies in addition
to standard biopsies
2. Prospective phase For the performance measurement, a test set of 550 prospectively
collected images will be used, of which 150 will be from the same centers, and 400
from 3 other clinical centers (CHU Strasbourg, APHP Bicêtre and Necker-HEGP and CHU
Bordeaux).
The algorithms developed in the retrospective phase will be applied by Inria to the
prospective data, without knowledge of the PI-RADS score or the aggressiveness. The
performance of each algorithm will then be evaluated, under the responsibility of an
independent unit,by its sensitivity and specificity with their IC95%. The main analysis
will be conducted by patient (presence of at least one lesion with a PI-RADS score ≥3;
presence of at least one lesion considered aggressive (defined by the presence of a
histological Gleason score grade 4 up to 6 months after the mpMRI). Secondary analyses
will be conducted by lesion and by prostate lobe.
Criteria for eligibility:
Study pop:
Patients with clinical suspicion of prostate cancer
Sampling method:
Non-Probability Sample
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
La Pitié Salpétrière Hospital
Address:
City:
Paris
Zip:
75013
Country:
France
Status:
Recruiting
Contact:
Last name:
Sofia ZEMOURI
Phone:
33 1 42 16 75 75
Email:
sofia.zemouri@aphp.fr
Start date:
June 21, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Collaborator:
Agency:
University Hospital, Strasbourg, France
Agency class:
Other
Collaborator:
Agency:
University Hospital, Bordeaux
Agency class:
Other
Collaborator:
Agency:
University Hospital, Lille
Agency class:
Other
Collaborator:
Agency:
The Civil Hospitals, Lyon
Agency class:
Other
Collaborator:
Agency:
Institut National de Recherche en Informatique et en Automatique
Agency class:
Other
Collaborator:
Agency:
INCEPTO
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05513820