Prostate CancerPRISM-AINCT06468332
Artificial Intelligence-based Platform, Integrating Pathologic, Imaging and Molecular Profiles of Prostate Cancer
An observational study of Prostate Cancer, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial summary
The goal of this observational study is to use an artificial intelligence-based platform, integrating clinical, pathologic, imaging, genomic and transcriptomic profiles of prostate cancer in order to outperform currently available risk-stratification tools. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 30 Oct 2024to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: multi-centre cohort of patients from division of urology
Who may be able to join
- Adults patients, aged between 18 and 80 years
- Signed an informed consent form (ICF) indicating that the subject or his closest relative understands the purpose of and procedures required for the study and is willing to participate in the study; subjects must be willing to allow MRI anonymized revision and processing and biopsy/Radical Prostatectomy (RP) material genomic/transcriptomic and exploratory analyses. Moreover they must be willing to adhere to normal clinical follow-up.
- Availability of MRI conducted prior to RP, with at least T2 weighted image (T2W), diffusion-weighted imaging (DWI), dynamic contrast-enhanced (DCE) sequences in accordance with the American College of Radiology standards for Prostate Imaging-Reporting and Data System (PI-RADS) evaluation. This criterion is not mandatory for the metastatic cohort.
- Availability of formalin-fixed paraffin-embedded (FFPE) radical prostatectomy specimen for genomic, transcriptomic and exploratory analyses. Prostate or metastasis biopsy FFPE are acceptable for the metastatic cohort.
- Histological diagnosis of adenocarcinoma of the prostate
- Availability of PSA dosage and clinical evaluation of the tumor (via digital rectal exam [DRE]) in the 3 months preceding surgery (except for the metastatic cohort, where surgery does not apply).
- Availability of at least one postoperative prostate specific antigen (PSA) in between 3 and 8 weeks after surgery (except for the metastatic cohort, where surgery does not apply).
- Minimal follow-up duration of 2 years (or until death) after surgery (or after diagnosis for the metastatic patient).
Who cannot join
- Bilateral orchiectomy
- Neoadjuvant hormone therapy or any prostate cancer-directed therapy before radical prostatectomy
- History of pelvic radiation before RP.
- Active malignancy in the last 24 months, excluding Prostate Cancer, Non-muscle-invasive Bladder Cancer (NMIBC), cured skin cancer (excluding melanoma) or other malignancies with minimal risk of recurrence.
- Active surveillance lasting more than 12 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
AOU Maggiore della Carità, Urology Division
Novara, 28100
Carlotta Palumbo, MD, carlotta.palumbo@uniupo.it
About this study
Official title: Development of Artificial Intelligence-based Multiplex Network for Individualized Risk Stratification of Prostate Cancer
The goal of this observational study is to use an artificial intelligence-based platform, integrating clinical, pathologic, imaging, genomic and transcriptomic profiles of prostate cancer in order to outperform currently available risk-stratification tools. Thus could lead to a better risk assessment of prostate cancer progression and recurrence.
A key challenge in managing non-metastatic Prostate Cancer is identifying and distinguishing between men that are likely to progress to clinically significant disease and those whose disease is likely to remain indolent for the remainder of their lifetime, aiming to offer invasive treatment only to patients harboring a disease which would affect cancer specific survival.
Read more
In the context of a multidisciplinary team of urologists and digital health experts, a two-phases study has been designed. A retrospective cohort of 200 radical prostatectomy patients will be identified within three participating clinical centres. Clinical, pathology, MRI data will be collected and stored in an appropriate anonymised online platform. Whole exome sequences (DNAseq) will be analyzed for each patients (total samples=200) and transcriptome analyses (RNAseq) for both cancer and non-cancer tissues (total samples=400). In parallel, the recruitment of a prospective cohort of 200 biopsy-proven newly PCa patients will start. For these patients, blood and urine samples will be also collected. Data will be collected and genetic analyses (total samples=1,000) will be performed as in the retrospective phase. Patients will be treated and followed according to best clinical practice.
Expected Results The retrospective phase would allow to identify genes, pathological features and MRI imaging features that can correlate with PCa biology, in order to create and train the AI-based algorithm. The prospective phase will allow the validation of the prognostic tool, the definition of a novel risk grouping and the evaluation of the prognostic role of biofluid analysis.
- Conditions
- Prostate Cancer
- Keywords
- non-metastatic prostate cancer, surveillance, artificial intelligence
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | very-low aggressiveness, 20% of participants | |
| Group B | low aggressiveness, 20% of participants | |
| Group C | intermediate aggressiveness, 20% of participants | |
| Group D | high aggressiveness, 30% of participants | |
| Group E | high aggressiveness, 10% of participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
integration of pathologic, imaging, genomic and transcriptomic profiles of prostate cancer
Main outcome of preliminary phase is represented by the capability of the multiplex network to integrate several information in order to set up and build an artificial intelligence-based platform which is able to better define risk-stratification in prostate cancer. In this phase Formalin-fixed, paraffin-embedded tissue will be analyzed at molecular levels: genomic and trascriptomic information will be integrated with imaging and pathological information
Measured: 12 months
Validation of the artificial intelligence-based platform generated in the previous phase
in the prospective phase will be the validation of the prognostic tool, the definition of a novel risk grouping and the evaluation of the prognostic role of biofluid analysis.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start30 Oct 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2030 (estimated)
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
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlotta Palumbo, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Carlotta Palumbo, MD, Principal investigator, University of Piemonte Orientale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468332
- Sponsor's protocol ID
- CE137/2024
- Acronym
- PRISM-AI
- Status last verified
- Jan 2025
- First submitted
- 10 Jun 2024
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Artificial Intelligence-based Multiplex Network for Individualized Risk Stratification of Prostate Cancer
- ClinicalTrials.gov ID
- NCT06468332
- Acronym / sponsor ID
- PRISM-AI / CE137/2024
- Conditions
- Prostate Cancer
- Keywords
- non-metastatic prostate cancer, surveillance, artificial intelligence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 21 Jun 2024 (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.
The goal of this observational study is to use an artificial intelligence-based platform, integrating clinical, pathologic, imaging, genomic and transcriptomic profiles of prostate cancer in order to outperform currently available risk-stratification tools. Thus could lead to a better risk assessment of prostate cancer progression and recurrence.
A key challenge in managing non-metastatic Prostate Cancer is identifying and distinguishing between men that are likely to progress to clinically significant disease and those whose disease is likely to remain indolent for the remainder of their lifetime, aiming to offer invasive treatment only to patients harboring a disease which would affect cancer specific survival.
In the context of a multidisciplinary team of urologists and digital health experts, a two-phases study has been designed. A retrospective cohort of 200 radical prostatectomy patients will be identified within three participating clinical centres. Clinical, pathology, MRI data will be collected and stored in an appropriate anonymised online platform. Whole exome sequences (DNAseq) will be analyzed for each patients (total samples=200) and transcriptome analyses (RNAseq) for both cancer and non-cancer tissues (total samples=400). In parallel, the recruitment of a prospective cohort of 200 biopsy-proven newly PCa patients will start. For these patients, blood and urine samples will be also collected. Data will be collected and genetic analyses (total samples=1,000) will be performed as in the retrospective phase. Patients will be treated and followed according to best clinical practice.
Expected Results The retrospective phase would allow to identify genes, pathological features and MRI imaging features that can correlate with PCa biology, in order to create and train the AI-based algorithm. The prospective phase will allow the validation of the prognostic tool, the definition of a novel risk grouping and the evaluation of the prognostic role of biofluid analysis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –very-low aggressiveness, 20% of participants |
| Group B | – | –low aggressiveness, 20% of participants |
| Group C | – | –intermediate aggressiveness, 20% of participants |
| Group D | – | –high aggressiveness, 30% of participants |
| Group E | – | –high aggressiveness, 10% of participants |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- multi-centre cohort of patients from division of urology
Key inclusion criteria (8 listed)
- Adults patients, aged between 18 and 80 years
- Signed an informed consent form (ICF) indicating that the subject or his closest relative understands the purpose of and procedures required for the study and is willing to participate in the study; subjects must be willing to allow MRI anonymized revision and processing and biopsy/Radical Prostatectomy (RP) material genomic/transcriptomic and exploratory analyses. Moreover they must be willing to adhere to normal clinical follow-up.
- Availability of MRI conducted prior to RP, with at least T2 weighted image (T2W), diffusion-weighted imaging (DWI), dynamic contrast-enhanced (DCE) sequences in accordance with the American College of Radiology standards for Prostate Imaging-Reporting and Data System (PI-RADS) evaluation. This criterion is not mandatory for the metastatic cohort.
- Availability of formalin-fixed paraffin-embedded (FFPE) radical prostatectomy specimen for genomic, transcriptomic and exploratory analyses. Prostate or metastasis biopsy FFPE are acceptable for the metastatic cohort.
- Histological diagnosis of adenocarcinoma of the prostate
Key exclusion criteria (5 listed)
- Bilateral orchiectomy
- Neoadjuvant hormone therapy or any prostate cancer-directed therapy before radical prostatectomy
- History of pelvic radiation before RP.
- Active malignancy in the last 24 months, excluding Prostate Cancer, Non-muscle-invasive Bladder Cancer (NMIBC), cured skin cancer (excluding melanoma) or other malignancies with minimal risk of recurrence.
- Active surveillance lasting more than 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
integration of pathologic, imaging, genomic and transcriptomic profiles of prostate cancer
Time frame: 12 months
Main outcome of preliminary phase is represented by the capability of the multiplex network to integrate several information in order to set up and build an artificial intelligence-based platform which is able to better define risk-stratification in prostate cancer. In this phase Formalin-fixed, paraffin-embedded tissue will be analyzed at molecular levels: genomic and trascriptomic information will be integrated with imaging and pathological information
Validation of the artificial intelligence-based platform generated in the previous phase
Time frame: 3 years
in the prospective phase will be the validation of the prognostic tool, the definition of a novel risk grouping and the evaluation of the prognostic role of biofluid analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Carlotta Palumbo, MD principal investigator
University of Piemonte Orientale
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, run by Azienda Ospedaliero Universitaria Maggiore della Carita 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 8 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 31 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlotta Palumbo, MD (+393491289501, carlotta.palumbo@uniupo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
integration of pathologic, imaging, genomic and transcriptomic profiles of prostate cancer (time frame: 12 months). The study lists 2 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 31 Jan 2025.