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OpenTrials
Completed

NCT Number: NCT05384002

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Magnetic Resonance Imaging

Diagnostic Test

Patients who underwent MRI with confirmed pathology data (either biopsy or prostatectomy)

Primary outcomes

  1. To create a repository (Prostate-NET) of retrospective MRI examinations with related clinical and pathology data dedicated to prostate cancer.

    Time frame: 24 months

  2. 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.

    Time frame: 36 months

  3. To develop vendor-specific and vendor neutral AI models exploiting the prospective data that will be uploaded to the Prostate-NET platform.

    Time frame: 48 months

Sponsors and collaborators

Lead sponsor

Fondazione del Piemonte per l'Oncologia

Other

Collaborators

  • Advantis Medical Imaging
  • Agios Savas
  • BIOTRONICS 3D LIMITED
  • Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
  • Fundacao Champalimaud
  • Fundacion Para La Investigacion Hospital La Fe
  • Hacettepe University
  • IDRYMA TECHNOLOGIAS KAI EREVNAS
  • Institut Paoli-Calmettes
  • Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
  • JCC DIAGNOSTIC IMAGING
  • National Cancer Institute (NCI)
  • QS INSTITUTO DE INVESTIGACION E INNOVACION SL
  • QUIBIM SOCIEDAD LIMITADA
  • Royal Marsden NHS Foundation Trust
  • Stichting Katholieke Universiteit
  • THE GENERAL HOSPITAL CORPORATION
  • University of Pisa
  • University of Vienna

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 20, 2022
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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