NCT07875491Not yet recruiting
Artificial Intelligence Software (Prostate Intelligence) for Detecting Clinically Significant Prostate Cancer on MRI
A Prospective, Multi-Centre Diagnostic Accuracy Study of AI-based Prostate Cancer Diagnosis Software
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 226 (estimated)
- First submitted
- 8 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Prostate cancer
- NCT number
- NCT07875491
What you commit to
- Study type: Interventional
- Planned participants: 226
- From 1 Nov 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Failure to sign informed consent and/or consent to personal data processing
Other
- Contraindications to MRI
- Contraindications to prostate biopsy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.