An AI Platform Integrating Imaging Data and Models, Supporting Precision Care Through Prostate Cancer's Continuum

Study Overview
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Brief Summary
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In Europe, prostate cancer (PCa) is the second most frequent type of cancer in men and the third most lethal. Current clinical practices, often leading to overdiagnosis and overtreatment of indolent tumors, suffer from lack of precision calling for advanced AI models to go beyond SoA by deciphering non-intuitive, high-level medical image patterns and increase performance in discriminating indolent from aggressive disease, early predicting recurrence and detecting metastases or predicting effectiveness of therapies. To date efforts are fragmented, based on single-institution, size-limited and vendorspecific datasets while available PCa public datasets (e.g. US TCIA) are only few hundred cases making model generalizability impossible. The ProCAncer-I project brings together 20 partners, including PCa centers of reference, world leaders in AI and innovative SMEs, with recognized expertise in their respective domains, with the objective to design, develop and sustain a cloud based, secure European Image Infrastructure with tools and services for data handling. The platform hosts the largest collection of PCa multi-parametric (mp)MRI, anonymized image data worldwide (>17,000 cases), based on data donorship, in line with EU legislation (GDPR). Robust AI models are developed, based on novel ensemble learning methodologies, leading to vendor-specific and -neutral AI models for addressing 8 PCa clinical scenarios. To accelerate clinical translation of PCa AI models, we focus on improving the trust of the solutions with respect to fairness, safety, explainability and reproducibility. Metrics to monitor model performance and a causal explainability functionality are developed to further increase clinical trust and inform on possible failures and errors. A roadmap for AI models certification is defined, interacting with regulatory authorities, thus contributing to a European regulatory roadmap for validating the effectiveness of AI-based models for clinical decision making.

Official Title
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An AI Platform Integrating Imaging Data and Models, Supporting Precision Care Through Prostate Cancer's Continuum

Conditions
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Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer Recurrent, Prostate Cancer Aggressiveness

Intervention / Treatment
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* Diagnostic Test: Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histological confirmed PCa or suspicion of PCa (abnormal PSA values and/or positive DRE); magnetic resonance imaging examination, including at least a high-resolution axial T2-weighted imaging and axila diffusion-weighted imaging (dynamic contrast-enhanced imaging is recommended, but not mandatory); age ≥ 18 years at the time of diagnosis signed written informed consent form (only for prospective enrollement).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective (training model)<br> | Diagnostic Test: Magnetic Resonance Imaging<br>* Patients who underwent MRI with confirmed pathology data (either biopsy or prostatectomy)<br>|
| Prospective (validation model)<br> | Diagnostic Test: Magnetic Resonance Imaging<br>* Patients who underwent MRI with confirmed pathology data (either biopsy or prostatectomy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To create a repository (Prostate-NET) of retrospective MRI examinations with related clinical and pathology data dedicated to prostate cancer. |  | 24 months | 
| To use the retrospective data collection (Prostate-NET) to solve 9 different clinical scenarios to improve diagnosis, characterization, treatment and follow-up of men with prostate cancer. |  | 36 months | 
| To develop vendor-specific and vendor neutral AI models exploiting the prospective data that will be uploaded to the Prostate-NET platform. |  | 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, repository, open image space, annotated and under donorship images, quality of image providers, cloud infrastructure, tools to build AI applications, advanced AI techniques