AI Software Reading Prostate MRI Scans to Find Significant Prostate Cancer
Tests AI software that reads prostate MRI scans in adults with suspected prostate cancer.
Plain-language title generated from the registry record
Registry title: Artificial Intelligence Software (Prostate Intelligence) for Detecting Clinically Significant Prostate Cancer on MRI
Key facts
- Where
- Rome, ItalySee the site
Where in Italy
- Fondazione Policlinico Universitario A. Gemelli IRCCSRome, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- NCT07875491
- Record updated
- 15 October 2026
- Original description
The goal of this study is to learn how accurately an artificial intelligence (AI) software called Prostate Intelligence (Pi) detects clinically significant prostate cancer on prostate MRI in adults with a prostate gland who are referred for MRI because prostate cancer is suspected.Read full original descriptionShow less
A Prospective, Multi-Centre Diagnostic Accuracy Study of AI-based Prostate Cancer Diagnosis Software
The goal of this study is to learn how accurately an artificial intelligence (AI) software called Prostate Intelligence (Pi) detects clinically significant prostate cancer on prostate MRI in adults with a prostate gland who are referred for MRI because prostate cancer is suspected.
The main question it aims to answer is:
- How sensitive and specific is Pi, used on its own, in detecting clinically significant prostate cancer (Gleason grade 3+4 or higher) at the patient level?
Researchers will also compare Pi, the radiologist alone, and the radiologist assisted by Pi, to see whether AI assistance changes cancer detection.
Participants will:
* Undergo prostate MRI as part of their usual clinical care. Each MRI is first read by a radiologist without the AI result; the Pi report is then shown to the radiologist, who produces a final combined report. * Undergo targeted prostate biopsy (up to two lesions) if the MRI is suspicious, as in routine practice. Areas flagged only by Pi may also be biopsied. * If not biopsied, be followed for 12 months after MRI with PSA tests at 6 and 12 months and clinical assessment, to confirm the absence of clinically significant cancer.
About 226 participants will be enrolled at two Italian centres (Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, and IRCCS Ospedale San Raffaele, Milan).
Inclusion: Individuals with a prostate gland (biological males, including transgender women with a prostate gland); Age 18 years or older; Referred for prostate MRI for suspected prostate cancer; Signed informed consent and consent to personal data processing.
Exclusion: Previous prostate biopsy; Previous treatment for prostate cancer or benign prostatic hyperplasia; Any factor that may compromise MRI scan quality (e.g. metal implants, UroLift); Failure to sign informed consent and/or consent to personal data processing; Contraindications to MRI; Contraindications to prostate biopsy.