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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05384002 on ClinicalTrials.gov