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NCT05384002Completed

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

Source: ClinicalTrials.gov · Last updated 4 Jun 2026

Brief summary (registry, in English)

In Europe, prostate cancer (PCa) is the second most frequent type of cancer in men and the fifth 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 (\>14,000 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.

Status (registry)
Completed
Study type
Observational
Enrollment
14000 (actual)
First submitted
17 May 2022
Start date
24 Feb 2021
Primary completion date
31 Mar 2025
Lead sponsor
Fondazione del Piemonte per l'Oncologia
NCT number
NCT05384002

What you commit to

  • Study type: Observational
  • Participants enrolled: 14000
  • From 24 Feb 2021 to the primary completion date, 31 Mar 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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).

Age in the registry: 18 years to 85 years · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Fondazione del Piemonte per l'Oncologia
Coordinator of this site? Confirm its status
CandioloItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.