Prostate CancerNCT05384002
An AI Platform Integrating Imaging Data and Models, Supporting Precision Care Through Prostate Cancer's Continuum
An observational study of Prostate Cancer and Prostate Cancer Metastatic, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer Recurrent
- What is being tested?
- Magnetic Resonance Imaging
- How many people
- 14,000 participants
- Where
- 1 siteItaly
- Study dates
- 24 Feb 2021to 31 Mar 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who underwent MRI examination with pathological confirmation of prostate cancer (positive group) or at least 1-year follow-up to exclude presence of prostate cancer (negative group).
Who may be able to join
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer Recurrent, Prostate Cancer Aggressiveness
- Being tested
- Magnetic Resonance Imaging
- 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
- Medical subject headings
- Prostatic Neoplasms, Prostate Cancer, Hereditary, 7
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDiagnostic test
Patients who underwent MRI with confirmed pathology data (either biopsy or prostatectomy)
| Study group | Role | What they receive |
|---|---|---|
| Retrospective (training model) | Not described Receives: Diagnostic Test: Magnetic Resonance Imaging | |
| Prospective (validation model) | Not described Receives: Diagnostic Test: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
To create a repository (Prostate-NET) of retrospective MRI examinations with related clinical and pathology data dedicated to prostate cancer.
Measured: 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.
Measured: 36 months
To develop vendor-specific and vendor neutral AI models exploiting the prospective data that will be uploaded to the Prostate-NET platform.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start24 Feb 2021
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 14,000 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacao Champalimaud, Stichting Katholieke Universiteit, Fundacion Para La Investigacion Hospital La Fe, University of Pisa, Institut Paoli-Calmettes, Hacettepe University, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta, JCC DIAGNOSTIC IMAGING, National Cancer Institute (NCI), Agios Savas, Royal Marsden NHS Foundation Trust, QS INSTITUTO DE INVESTIGACION E INNOVACION SL, IDRYMA TECHNOLOGIAS KAI EREVNAS, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, THE GENERAL HOSPITAL CORPORATION, BIOTRONICS 3D LIMITED, Advantis Medical Imaging, QUIBIM SOCIEDAD LIMITADA, University of Vienna
- Responsible party
- Sponsor
- Investigators
- Manolis Tsiknakis, Study director, FORTHNickolas Papanikolau, Study chair, Fundacao ChampalimaudKostantinos Marias, Study chair, FORTH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384002
- Sponsor's protocol ID
- ProCAncer-I
- Status last verified
- Jun 2026
- First submitted
- 17 May 2022
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An AI Platform Integrating Imaging Data and Models, Supporting Precision Care Through Prostate Cancer's Continuum
- ClinicalTrials.gov ID
- NCT05384002
- Acronym / sponsor ID
- ProCAncer-I
- Conditions
- Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer Recurrent, Prostate Cancer Aggressiveness
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,000 participants (actual)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Collaborators
- Fundacao Champalimaud, Stichting Katholieke Universiteit, Fundacion Para La Investigacion Hospital La Fe, University of Pisa, Institut Paoli-Calmettes, Hacettepe University, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta, JCC DIAGNOSTIC IMAGING, National Cancer Institute (NCI), Agios Savas, Royal Marsden NHS Foundation Trust, QS INSTITUTO DE INVESTIGACION E INNOVACION SL, IDRYMA TECHNOLOGIAS KAI EREVNAS, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, THE GENERAL HOSPITAL CORPORATION, BIOTRONICS 3D LIMITED, Advantis Medical Imaging, QUIBIM SOCIEDAD LIMITADA, University of Vienna
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective (training model) | – | Diagnostic Test: Magnetic Resonance Imaging |
| Prospective (validation model) | – | Diagnostic Test: Magnetic Resonance Imaging |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent MRI examination with pathological confirmation of prostate cancer (positive group) or at least 1-year follow-up to exclude presence of prostate cancer (negative group).
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingPatients who underwent MRI with confirmed pathology data (either biopsy or prostatectomy) | Diagnostic test | Prospective (validation model), Retrospective (training model) |
Primary outcome
To create a repository (Prostate-NET) of retrospective MRI examinations with related clinical and pathology data dedicated to prostate cancer.
Time frame: 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.
Time frame: 36 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manolis Tsiknakis study director
FORTH
Nickolas Papanikolau study chair
Fundacao Champalimaud
Kostantinos Marias study chair
FORTH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Prostate Cancer Metastatic, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To create a repository (Prostate-NET) of retrospective MRI examinations with related clinical and pathology data dedicated to prostate cancer. (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.