Digital pathology-based artificial intelligence (DP-AI) biomarkers are emerging as transformative tools to guide clinical management of patients affected by various malignancies. We aimed to synthesise current evidence regarding their prognostic and predictive utility in urologic cancers.
In this prospectively registered systematic review (PROSPERO: CRD420251036536), we searched MEDLINE, Embase, and Web of Science in April 2025 for studies evaluating the prognostic and predictive values of DP-AI models in patients with prostate (PCa), bladder (BCa), renal cell (RCC), testicular (TCa), or penile (PeCa) cancer. The risk of bias was assessed using the Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) tool. Results were tabulated and summarised qualitatively.
Of the 1537 screened individual records, we included 31 studies validating DP-AI models in 21 155 patients. Nineteen studies were conducted in PCa (n = 17 541), six in BCa (n = 2349), five in RCC (n = 1176), and one in TCa (n = 89) patients. Ten PCa studies (n = 8951) utilised the ArteraAI model, including two (n = 2786) showing that it allows identification of patients treated with radiotherapy for clinically localised PCa that can safely omit short-term (subdistribution hazard ratio [sHR] 0.34; 95% confidence interval [CI]: 0.19-0.63) or long-term (sHR 0.55; 95% CI: 0.41-0.73) androgen deprivation therapy. Two studies (n = 894) developed and validated a model allowing identification of patients with non-muscle-invasive BCa poorly responding to Bacillus Calmette-Guérin (HR 2.3; 95% CI: 1.9-2.8), including one study (n = 253) validating a predictive biomarker for patients who may benefit from upfront gemcitabine/docetaxel. Many DP-AI models showed a prognostic association in localised PCa (n = 16 863), metastatic PCa (n = 678), non-muscle-invasive BCa (n = 2069), muscle-invasive BCa (n = 280), localised RCC (n = 1176), and germline TCa (n = 89) settings. None of the included studies assessed DP-AI models prospectively.
DP-AI biomarkers hold promise to improve treatment personalisation through integration into clinical practice. Prospective validation is now required.
European urology focus. 2025 Dec 17 [Epub ahead of print]
Navid Roessler, Marcin Miszczyk, Keiichiro Miyajima, Alessandro Dematteis, Ahmed R Alfarhan, Angelo Cormio, Abdulrahman S Alqahtani, Tamás Fazekas, Victor M Schuettfort, Malte W Vetterlein, Yipeng Hu, Veeru Kasivisvanathan, Constantinos Zamboglou, Michael S Leapman, Margit Fisch, Markus Eckstein, Mahul B Amin, Giovanni Enrico Cacciamani, Liang Cheng, Pierre I Karakiewicz, Pawel Rajwa, Shahrokh F Shariat
Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Collegium Medicum, Faculty of Medicine, WSB University, Dąbrowa Górnicza, Poland., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Urology, Jikei University School of Medicine, Tokyo, Japan., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Surgical Sciences, Division of Urology, AOU Citt'a della Salute e della Scienza at Molinette Hospital and University of Turin, Turin, Italy., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Urology, Prince Saud Bin Jalawi Hospital, Al Ahsa Health Cluster, Al Ahsa, KSA., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Urology, Azienda Ospedaliero-Universitaria Ospedali Riuniti Di Ancona, Università Politecnica Delle Marche, Ancona, Italy., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Urology, Second Health Cluster Riyadh, Ministry of Health, Riyadh, KSA., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Centre for Translational Medicine, Semmelweis University, Budapest, Hungary; Department of Urology, Semmelweis University, Budapest, Hungary., Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Department of Medical Physics and Biomedical Engineering, University College London, London, UK., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Centre for Urology Imaging, Prostate, AI and Surgical Studies (COMPASS) Research Group, Division of Surgery and Interventional Science, UCL, London, UK., Department of Radiation Oncology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany; German Oncology Center, European University of Cyprus, Limassol, Cyprus., Department of Urology, Yale University, New Haven, CT, USA., Institute of Pathology, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany., Department of Pathology and Laboratory Medicine, University of Tennessee Health Science Center, Memphis, TN, USA; Department of Urology, USC Keck School of Medicine, Los Angeles, CA, USA., USC Institute of Urology and Catherine and Joseph Aresty Department of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA., Department of Pathology and Laboratory Medicine, Department of Surgery (Urology), Brown University Warren Alpert Medical School, Providence, RI, USA; Legorreta Cancer Center at Brown University, Providence, RI, USA; Brown University Health, Providence, RI, USA., Cancer Prognostics and Health Outcomes Unit, Division of Urology, University of Montréal Health Center, Montréal, Canada., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Division of Surgery and Interventional Sciences, University College London, London, UK; Department of Urology, Medical University of Silesia, Zabrze, Poland., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Urology, Weill Cornell Medical College, New York, New York, USA; Department of Urology, University of Texas Southwestern, Dallas, Texas, USA; Department of Urology, Second Faculty of Medicine, Charles University, Prague, Czech Republic; Hourani Center for Applied Scientific Research, Al-Ahliyya Amman University, Amman, Jordan; Karl Landsteiner Institute of Urology and Andrology, Vienna, Austria. Electronic address: .
PubMed http://www.ncbi.nlm.nih.gov/pubmed/41412890