Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) software | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy in detecting csPCa of Quantib Prostate vs. traditional radiologist reading of mpMRI
- timeFrame
- 12
Secondary outcomes (2)
- measure
- To assess the impact of Quantib Prostate in predicting pathologic outcomes in patients who received radical prostatectomy
- timeFrame
- 12
- measure
- To report time reduction in the diagnosis of suspicious PCa
- timeFrame
- 12
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men at least 18 years of age referred with clinical suspicion of prostate cancer 2. Men who have undergone mpMRI and subsequent targeted plus random systematic prostate biopsies 3. Available pathological report with details regarding the site of positive cores and grade group 4. Serum PSA ≤ 20 5. 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 Exclusion Criteria: NA
References
Publications (1)
- DERIVEDRusso T, Quarta L, Pellegrino F, Cosenza M, Camisassa E, Lavalle S, Apostolo G, Zaurito P, Scuderi S, Barletta F, Marzorati C, Stabile A, Montorsi F, De Cobelli F, Brembilla G, Gandaglia G, Briganti A. The added value of artificial intelligence using Quantib Prostate for the detection of prostate cancer at multiparametric magnetic resonance imaging. Radiol Med. 2025 Jul;130(7):1105-1114. doi: 10.1007/s11547-025-02017-8. Epub 2025 May 7. PMID 40332649