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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05384002
• Other study ID #: ProCAncer-I
• Status: Recruiting
• Start date: February 24, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2022
• Source: Fondazione del Piemonte per l'Oncologia
• Contact: Daniele Regge, MD
• Phone: +39011993
• Email: daniele.regge[@]ircc.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17000
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Aggression
• Prostate Cancer
• Prostate Cancer Aggressiveness
• Prostate Cancer Metastatic
• Prostate Cancer Recurrent
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Magnetic Resonance Imaging
Patients who underwent MRI with confirmed pathology data (either biopsy or prostatectomy)

Locations

Country	Name	City	State
Italy	Fondazione del Piemonte per l'Oncologia	Candiolo

Sponsors (20)

Lead Sponsor

Collaborator

Fondazione del Piemonte per l'Oncologia

ADVANTIS MEDICAL IMAGING SINGLE MEMBER PC, BIOTRONICS 3D LIMITED, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, Fundacao Champalimaud, FUNDACIO INSTITUT D'INVESTIGACIO BIOMEDICA DE GIRONA DOCTOR JOSEP TRUETA, Fundacion Para La Investigacion Hospital La Fe, General Anti-Cancer and Oncological Hospital of Athens St. Savvas, Hacettepe University, IDRYMA TECHNOLOGIAS KAI EREVNAS, Institut Paoli-Calmettes, João Carlos Costa - Diagnóstico por Imagem, S.A., 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, UNIVERSITAT WIEN, University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

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