NCT06298305Completed
Artificial Intelligence & Prostate Cancer
The Role of Artificial Intelligence in the Assessment of Multiparametric Resonance of the Prostate in Prostate Cancer Patients
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
This is a single center, blinded (the mpMRI will be read by expert personnel not aware of the patient's diagnosis ), retrospective study. A total of 200 patients with suspicious prostate cancer (PCa) who underwent, between January 2014 and January 2022, mpMRI of the prostate and subsequent prostate biopsy will identified. All mpMRI images will be retrospectively collected and evaluated using the Quantib Prostate software. In particular, 200 mpMRI with endorectal coil will be read by the expert radiologist and by the Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) software, thus evaluating the predictive characteristics of Quantib Prostate for the identification of suspicious lesions. The sensitivity, specificity, negative predictive value, positive predictive value and accuracy of Quantib Prostate vs. radiologist in detecting csPCa will be evaluated using the biopsy report as reference standard.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 20 Feb 2024
- Start date
- 8 Mar 2023
- Primary completion date
- 2 Sept 2024
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Prostate cancer
- NCT number
- NCT06298305
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 8 Mar 2023 to the primary completion date, 2 Sept 2024
- 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.
Other
- NA
Who the study is looking for
- Men at least 18 years of age referred with clinical suspicion of prostate cancer
- Men who have undergone mpMRI and subsequent targeted plus random systematic prostate biopsies
- Available pathological report with details regarding the site of positive cores and grade group
- Serum PSA ≤ 20
- Patient who underwent a 1.5T mpMRI with or without endorectal coil with the following protocol restrictions and according to recent European Guidelines, each case containing at least the following sequences, will be considered:
- T2w
- No fat suppression
- At least axial acquisition
- Max voxel size 1.0x1.0x3.0mm DWI
- At least on b-value ≥800 s/mm\^2 required, ≥1400 s/mm\^2 preferred
- ADC map required
- Max voxel size: 2.0x2.0x4.0mm
- Axial scanning protocol only DCE scan
- Recommended temporal resolution \<15s
- Axial scanning protocol only
Age in the registry: 18 years to - · Sex: Male
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.