An AI Platform Integrating Imaging Data and Models, Supporting Precision Care Through Prostate Cancer's Continuum
NCT05384002 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14000
Last updated 2025-04-04
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
- DIAGNOSTIC_TEST
-
Magnetic Resonance Imaging
Patients who underwent MRI with confirmed pathology data (either biopsy or prostatectomy)
Sponsors & Collaborators
-
Fundacao Champalimaud
collaborator OTHER -
Stichting Katholieke Universiteit
collaborator OTHER -
Fundacion Para La Investigacion Hospital La Fe
collaborator OTHER -
University of Pisa
collaborator OTHER -
Institut Paoli-Calmettes
collaborator OTHER -
Hacettepe University
collaborator OTHER -
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
collaborator OTHER -
JCC DIAGNOSTIC IMAGING
collaborator UNKNOWN -
National Cancer Institute (NCI)
collaborator NIH -
Agios Savas
collaborator UNKNOWN -
Royal Marsden NHS Foundation Trust
collaborator OTHER -
QS INSTITUTO DE INVESTIGACION E INNOVACION SL
collaborator UNKNOWN -
IDRYMA TECHNOLOGIAS KAI EREVNAS
collaborator UNKNOWN -
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
collaborator OTHER_GOV -
THE GENERAL HOSPITAL CORPORATION
collaborator UNKNOWN -
BIOTRONICS 3D LIMITED
collaborator UNKNOWN -
Advantis Medical Imaging
collaborator UNKNOWN -
QUIBIM SOCIEDAD LIMITADA
collaborator UNKNOWN -
University of Vienna
collaborator OTHER -
Fondazione del Piemonte per l'Oncologia
lead OTHER
Principal Investigators
-
Manolis Tsiknakis · FORTH
-
Nickolas Papanikolau · Fundacao Champalimaud
-
Kostantinos Marias · FORTH
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-02-24
- Primary Completion
- 2025-03-31
- Completion
- 2025-03-31
Countries
- Italy
Study Locations
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