CompletedNCT06298305

The Role of Artificial Intelligence in the Assessment of Multiparametric Resonance of the Prostate in Prostate Cancer Patients

Sponsor: IRCCS San Raffaele

Trial Details

ConditionProstate Cancer
InterventionQuantib prostate (Quantib B.V. Rotterdam, The Netherlands) software
StatusCompleted
Participants200
Est. Completion2 Sept 2024
Last Updated18 May 2026

Primary Outcome

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

Eligibility Criteria

Inclusion Criteria

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

Trial Sites

Countries

Italy
View Registry Entry

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