Development and Validation of an Artificial Intelligence–Powered Platform for Prostate Cancer Grading and Quantification

IMPORTANCE: The Gleason grading system has been the most reliable tool for the prognosis of prostate cancer since its development. However, its clinical application remains limited by interobserver variability in grading and quantification, which has negative consequences for risk assessment and clinical management of prostate cancer. OBJECTIVE: To examine the impact of an artificial intelligence (AI)–assisted approach to prostate cancer grading and quantification. DESIGN, SETTING, AND PARTICIPANTS: This diagnostic study was conducted at the University of Wisconsin–Madison from August 2, 2017, to December 30, 2019. The study chronologically selected 589 men with biopsy-confirmed prostate cancer who received care in the University of Wisconsin Health System between January 1, 2005, and February 28, 2017. A total of 1000 biopsy slides (1 or 2 slides per patient) were selected and scanned to create digital whole-slide images, which were used to develop and validate a deep convolutional neural network–based AI-powered platform. The whole-slide images were divided into a training set (n = 838) and validation set (n = 162). Three experienced academic urological pathologists (W.H., K.A.I., and R.H., hereinafter referred to as pathologists 1, 2, and 3, respectively) were involved in the validation. Data were collected between December 29, 2018, and December 20, 2019, and analyzed from January 4, 2020, to March 1, 2021. MAIN OUTCOMES AND MEASURES: Accuracy of prostate cancer detection by the AI-powered platform and comparison of prostate cancer grading and quantification performed by the 3 pathologists using manual vs AI-assisted methods. RESULTS: Among 589 men with biopsy slides, the mean (SD) age was 63.8 (8.2) years, the mean (SD) prebiopsy prostate-specific antigen level was 10.2 (16.2) ng/mL, and the mean (SD) total cancer volume was 15.4% (20.1%). The AI system was able to distinguish prostate cancer from benign prostatic epithelium and stroma with high accuracy at the patch-pixel level, with an area under the receiver operating characteristic curve of 0.92 (95% CI, 0.88-0.95). The AI system achieved almost perfect agreement with the training pathologist (pathologist 1) in detecting prostate cancer at the patch-pixel level (weighted κ = 0.97; asymptotic 95% CI, 0.96-0.98) and in grading prostate cancer at the slide level (weighted κ = 0.98; asymptotic 95% CI, 0.96-1.00). Use of the AI-assisted method was associated with significant improvements in the concordance of prostate cancer grading and quantification between the 3 pathologists (eg, pathologists 1 and 2: 90.1% agreement using AI-assisted method vs 84.0% agreement using manual method; P < .001) and significantly higher weighted κ values for all pathologists (eg, pathologists 2 and 3: weighted κ = 0.92 [asymptotic 95% CI, 0.90-0.94] for AI-assisted method vs 0.76 [asymptotic 95% CI, 0.71-0.80] for manual method; P < .001) compared with the manual method. CONCLUSIONS AND RELEVANCE: In this diagnostic study, an AI-powered platform was able to detect, grade, and quantify prostate cancer with high accuracy and efficiency and was associated with significant reductions in interobserver variability. These results suggest that an AI-powered platform could potentially transform histopathological evaluation and improve risk stratification and clinical management of prostate cancer.