Objective To evaluate the effectiveness of a self-adapting deep network, trained on large-scale bi-parametric MRI data, in detecting clinically significant prostate cancer (csPCa) in external multi-center data from men of diverse demographics; to investigate the advantages of transfer learning. Methods We used two samples: (i) Publicly available multi-center and multi-vendor Prostate Imaging: Cancer AI (PI-CAI) training data, consisting of 1500 bi-parametric MRI scans, along with its unseen validation and testing samples; (ii) In-house multi-center testing and transfer learning data, comprising 1036 and 200 bi-parametric MRI scans. We trained a self-adapting 3D nnU-Net model using probabilistic prostate masks on the PI-CAI data and evaluated its performance on the hidden validation and testing samples and the in-house data with and without transfer learning. We used the area under the receiver operating characteristic (AUROC) curve to evaluate patient-level performance in detecting csPCa. Results The PI-CAI training data had 425 scans with csPCa, while the in-house testing and fine-tuning data had 288 and 50 scans with csPCa, respectively. The nnU-Net model achieved an AUROC of 0.888 and 0.889 on the hidden validation and testing data. The model performed with an AUROC of 0.886 on the in-house testing data, with a slight decrease in performance to 0.870 using transfer learning. Conclusions The state-of-the-art deep learning method using prostate masks trained on large-scale bi-parametric MRI data provides high performance in detecting csPCa in internal and external testing data with different characteristics, demonstrating the robustness and generalizability of deep learning within and across datasets. Clinical relevance statement A self-adapting deep network, utilizing prostate masks and trained on large-scale bi-parametric MRI data, is effective in accurately detecting clinically significant prostate cancer across diverse datasets, highlighting the potential of deep learning methods for improving prostate cancer detection in clinical practice. Graphical Abstract

Objective To investigate whether commercially available deep learning (DL) software improves the Prostate Imaging-Reporting and Data System (PI-RADS) scoring consistency on bi-parametric MRI among radiologists with various levels of experience; to assess whether the DL software improves the performance of the radiologists in identifying clinically significant prostate cancer (csPCa). Methods We retrospectively enrolled consecutive men who underwent bi-parametric prostate MRI at a 3 T scanner due to suspicion of PCa. Four radiologists with 2, 3, 5, and > 20 years of experience evaluated the bi-parametric prostate MRI scans with and without the DL software. Whole-mount pathology or MRI/ultrasound fusion-guided biopsy was the reference. The area under the receiver operating curve (AUROC) was calculated for each radiologist with and without the DL software and compared using De Long’s test. In addition, the inter-rater agreement was investigated using kappa statistics. Results In all, 153 men with a mean age of 63.59 ± 7.56 years (range 53–80) were enrolled in the study. In the study sample, 45 men (29.80%) had clinically significant PCa. During the reading with the DL software, the radiologists changed their initial scores in 1/153 (0.65%), 2/153 (1.3%), 0/153 (0%), and 3/153 (1.9%) of the patients, yielding no significant increase in the AUROC (p > 0.05). Fleiss’ kappa scores among the radiologists were 0.39 and 0.40 with and without the DL software (p = 0.56). Conclusions The commercially available DL software does not increase the consistency of the bi-parametric PI-RADS scoring or csPCa detection performance of radiologists with varying levels of experience.