Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05384002
Enrollment
14000
Registered
2022-05-20
Start date
2021-02-24
Completion date
2025-03-31
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, Prostate Cancer Aggressiveness, Prostate Cancer Metastatic, Prostate Cancer Recurrent

Keywords

prostate cancer, repository, open image space, annotated and under donorship images, quality of image providers, cloud infrastructure, tools to build AI applications, advanced AI techniques

Brief summary

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.

Interventions

DIAGNOSTIC_TESTMagnetic Resonance Imaging

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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

1. histological confirmed PCa or suspicion of PCa (abnormal PSA values and/or positive DRE); 2. 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); 3. age ≥ 18 years at the time of diagnosis 4. signed written informed consent form (only for prospective enrollement).

Design outcomes

Primary

MeasureTime frame
To create a repository (Prostate-NET) of retrospective MRI examinations with related clinical and pathology data dedicated to prostate cancer.24 months
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.36 months
To develop vendor-specific and vendor neutral AI models exploiting the prospective data that will be uploaded to the Prostate-NET platform.48 months

Countries

Italy

Contacts

STUDY_DIRECTORManolis Tsiknakis

FORTH

STUDY_CHAIRNickolas Papanikolau

Fundacao Champalimaud

STUDY_CHAIRKostantinos Marias

FORTH

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026