Abstract

Objective: Quantib® Prostate is a commercially available machine learning software (MLS) used for prostate magnetic resonance imaging (MRI), approved by the Food and Drug Administration (FDA) and Conformité Européenne (CE). We aimed to assess the agreement between biparametric MRI (bpMRI) interpretations produced by radiologists and by Quantib® alone. Material and Methods: This single-centre, retrospective, and observational study included 188 bpMRI scans from the Innlandet Hospital Trust, Norway. Radiologists’ Prostate Imaging Reporting and Data System (PI-RADS) scores were compared with scores produced by the Quantib® Prostate PI-RADS, which was used as an autonomous software. Additionally, for exploratory purposes, the PI-RADS scores were compared with biopsy findings, using the radiologist’s scorings to determine biopsy indications. Results: For PI-RADS scores generated by radiologists vs. those produced by Quantib® Prostate, the weighted kappa was 0.49 (95% CI: 0.37–0.59), and 46% of the PI-RADS scores differed by at least one unit. In the sample, 125 men (66%) had a prostate biopsy, and for male patients with PI-RADS scores of 4–5, the probability of detecting cancer grades 2–5 via biopsies was 64% (95% CI: 56–71) for radiologists and 58% (95% CI: 54–62) for Quantib® Prostate. The main limitations of this study are the retrospective, single-centre design, the small sample size, the use of Quantib® Prostate in an autonomous manner, and verification bias, as the biopsy decisions were based solely on PI-RADS scoring by radiologists. Conclusions: We identified inter-rater variability between PI-RADS scores generated by Quantib® Prostate and radiologists’ assessments, and the agreement between the two scoring groups is moderate. Our results suggest that Quantib® Prostate requires further clinical comparative studies before it is used in clinical routines.

IPC Classification

Keywords