BACKGROUND: Positron Emission Tomography-Computed Tomography using Prostate-Specific Membrane Antigen (PSMA PET/CT) is notable for its superior sensitivity and specificity in detecting recurrent PCa and is under investigation for its potential in pre-treatment staging. Despite its established efficacy in nodal and metastasis staging in trial setting, its role in primary staging awaits fuller validation due to limited evidence on oncologic outcomes. This systematic review and meta-analysis aims to appraise the diagnostic accuracy of PSMA PET/CT compared to CI for comprehensive PCa staging. METHODS: Medline, Scopus and Web of science databases were searched till March 2023. Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines were followed to identify eligible studies. Primary outcomes were specificity, sensitivity, positive predictive value (PPV) and negative predictive value (NPV) of PSMA PET/CT for local, nodal and metastatic staging in PCa patients. Due to the unavailability of data, a meta-analysis was feasible only for detection of seminal vesicles invasion (SVI) and LNI. RESULTS: A total of 49 studies, comprising 3876 patients, were included. Of these, 6 investigated accuracy of PSMA PET/CT in detection of SVI. Pooled sensitivity, specificity, PPV and NPV were 42.29% (95%CI: 29.85-55.78%), 87.59% (95%CI: 77.10%-93.67%), 93.39% (95%CI: 74.95%-98.52%) and 86.60% (95%CI: 58.83%-96.69%), respectively. Heterogeneity analysis revealed significant variability for PPV and NPV. 18 studies investigated PSMA PET/CT accuracy in detection of LNI. Aggregate sensitivity, specificity, PPV and NPV were 43.63% (95%CI: 34.19-53.56%), 85.55% (95%CI: 75.95%-91.74%), 67.47% (95%CI: 52.42%-79.6%) and 83.61% (95%CI: 79.19%-87.24%). No significant heterogeneity was found between studies. CONCLUSIONS: The present systematic review and meta-analysis highlights PSMA PET-CT effectiveness in detecting SVI and its good accuracy in LNI compared to CI. Nonetheless, it also reveals a lack of high-quality research on its performance in clinical T staging, extraprostatic extension and distant metastasis evaluation, emphasizing the need for further rigorous studies.

Department of Health Sciences University of Genoa Genoa Italy

Department of Urology 2nd Faculty of Medicine Charles University Prague Czech Republic

Department of Urology and Division of Experimental Oncology URI Urological Research Institute IRCCS San Raffaele Scientific Institute 20132 Milan Italy

Department of Urology Hospital Universitario La Ribera Valencia Spain

Department of Urology Medical University of Vienna Vienna Austria

Department of Urology Rush University Medical Center Chicago IL USA

Department of Urology Sant'Andrea Hospital Sapienza University Rome Italy

Department of Urology University Hospital of Geneva Geneva Switzerland

Department of Urology University of Texas Southwestern Dallas TX USA

Department of Urology Weill Cornell Medical College New York NY 10065 USA

Department Surgery Oncology and Gastroenterology Urologic Unit University of Padova Padova Italy

Division of Urology Department of Surgical Sciences University of Turin and Città della Salute e della Scienza Turin Italy

Division of Urology IRCCS Azienda Ospedaliero Universitaria di Bologna Bologna Italy

European Association of Urology Research Foundation Arnhem The Netherlands

Hourani Center for Applied Scientific Research Al Ahliyya Amman University Amman Jordanien

Karl Landsteiner Institute of Urology and Andrology Vienna Austria

Nuclear Medicine Division Careggi University Hospital Florence Italy

Nuclear Medicine IRCCS Ospedale Policlinico San Martino Genoa Italy

Oncologic Minimally Invasive Urology and Andrology Unit Department of Experimental and Clinical Medicine Careggi Hospital University of Florence 50121 Florence Italy

Urology Predictive Onco Urology AP HP Urology Hôpital Pitié Salpêtrière Sorbonne Université Paris France

Urology Unit Department of Surgical Sciences Tor Vergata University Hospital University of Rome Tor Vergata Rome Italy

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