Artificial Intelligence-based Platform, Integrating Pathologic, Imaging and Molecular Profiles of Prostate Cancer (PRISM-AI)

January 29, 2025 updated by: Carlotta Palumbo, Azienda Ospedaliero Universitaria Maggiore della Carita

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.

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

multi-centre cohort of patients from division of urology

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Investigators

  • Principal Investigator: Carlotta Palumbo, MD, University of Piemonte Orientale

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 15, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE137/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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