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Research Article: Protocol for SNOTOB study: radical prostatectomy without prostate biopsy following 18F-PSMA-1007 PET/CT based on a diagnostic model: a single-centre, single-arm, open-label study

Date Published: 2023-11-19

Abstract:
Introduction Nowadays, invasive prostate biopsy is the standard diagnostic test for patients with suspected prostate cancer (PCa). However, it has some shortcomings such as perioperative complications, economic and psychological burden on patients, and some patients may undergo repeated prostate biopsy. In this study protocol, our aim is to provide a non-invasive diagnostic strategy we call the ‘prostate-specific membrane antigen (PSMA) combined model’ for the diagnosis of PCa. If patients are diagnosed with PCa using PSMA combined model, we want to prove these patients can receive radical prostatectomy directly without prior prostate biopsies. Methods The SNOTOB trial adopts a prospective, single-centre, single-arm, open-label study design. The PSMA combined model consists of a diagnostic model based on what we previously reported and 18 F-PSMA-1007 positron emission tomography/CT ( 18 F-PSMA-1007 PET/CT) examinations in series. First, patients use the diagnostic model (online address: https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/ ) to calculate the risk probability of clinically significant PCa (csPCa). When the risk probability of csPCa is equal or greater than 0.60, 18 F-PSMA-1007 PET/CT will be applied for further diagnosis. If patients are still considered as csPCa after 18 F-PSMA-1007 PET/CT examinations, we define this condition as positive results of PSMA combined model. Subsequently, we will recommend these patients to accept radical prostatectomy without prostate biopsy directly. Finally, the diagnostic performance of PSMA combined model will be verified with the pathological results. Totally, 57 patients need to be enrolled in this clinical trial. Ethics and dissemination This study was approved by the ethics committee of The First Affiliated Hospital of USTC (No. 2022KY-142). The results of this study will be published in peer-reviewed journals and reported at academic conferences. Trial registration number NCT05587192 .

Introduction:
Prostate cancer (PCa) is the most common malignant tumour in the male genitourinary system. According to recent data, PCa ranks first and second in terms of morbidity and mortality among male malignancies in western countries. 1 In China, with the rapid development of the economy and the application of early diagnosis technologies, the incidence and mortality of PCa are increasing rapidly. 2 At present, the main methods recommended by the guidelines for early diagnosis of PCa include digital rectal examination…

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