NCT05384002

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 14,000 (actual)
• Sponsor: Fondazione del Piemonte per l'Oncologia · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Prostate Cancer
• Prostate Cancer Metastatic
• Prostate Cancer Recurrent
• Prostate Cancer Aggressiveness

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Magnetic Resonance Imaging	Patients who underwent MRI with confirmed pathology data (either biopsy or prostatectomy)

Timeline

• Start date: 2021-02-24
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2022-05-20
• Last updated: 2025-04-04

Locations

1 site across 1 country: Italy