Diagnostic performance of a fully automated AI algorithm for lesion detection and PI-RADS classification in patients with suspected prostate cancer
Author Block: H. Engel1, A. Nedelcu1, R. Grimm2, H. Von Busch2, A. Sigle3, T. Krauß1, J. Weiß1, M. Benndorf4, B. Oerther1; 1Freiburg im Breisgau/DE, 2Forchheim/DE, 3Freiburg/DE, 4Detmold/DE
Purpose: To evaluate the diagnostic performance of a fully automated AI algorithm with lesion detection and PI-RADS classification in a cohort of consecutive patients verified by targeted and extensive systematic biopsies.
Methods or Background: This retrospective, single-centre study included consecutive patients who underwent 3T multiparametric prostate magnetic resonance imaging (MRI) performed between 05/2017 and 05/2020, followed by targeted transperineal ultrasound-fusion guided and systematic biopsy. The AI algorithm (syngo.via Prostate MR, VB60S HF01, Siemens Healthineers) was described in previous publications and is based on axial T2- and diffusion-weighted imaging sequences. The results of the AI algorithm were compared with those of human readers and the diagnostic performance was determined.
Results or Findings: The evaluation of 272 patients resulted in 436 target lesions. 135 patients (49.5%) had clinically significant prostate cancer (csPCa), 35 (12.8%) had clinically insignificant prostate cancer (ISUP=1) and 102 (37.5%) were benign. Patient-level cancer detection rates (CDRs) of csPCa for AI versus human reading were 11%/18% for PI-RADS ≤2, 24%/11% for PI-RADS 3, 54%/41% for PI-RADS 4, and 74%/92% for PI-RADS 5. The accuracy of the AI was significantly better (0.74 versus 0.63 at a threshold of PI-RADS ≥4, p <0.01). 62 patients with human reading PI-RADS ≥3 were correctly classified as true negative by AI.
Conclusion: The AI algorithm proved to be a reliable and robust tool for lesion detection and classification. Furthermore, the CDRs and distribution of PI-RADS assessment categories of the AI are consistent with the results of recent meta-analyses, indicating precise risk stratification.
Limitations: The limitations of our study are mainly its retrospective and monocentric design. Additionally, the study design based on histopathological verification implies an under-representation of negative MRI scans and a cohort that is not fully representative of the wider patient population.
Funding for this study: The licence of the AI algorithm was part of an unrestricted collaboration agreement between Siemens Healthineers and the Department of Radiology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg. While Siemens provided technical support, the study conception and design, as well as the analysis and interpretation of the data, were conducted independently. August Sigle received research support within the Berta-Ottenstein-Programme. Other than that, the authors declare that no funds, grants, or other support were received during the preparation of this manuscript.
Has your study been approved by an ethics committee? Yes
Ethics committee - additional information: Approval was granted by the Ethics Committee of the University of Freiburg (No. 20-1256).