Department of Urology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.
Department of Urology, Anhui Provincial Hospital, Anhui Medical University, Hefei, China.
BMJ Open. 2023 Nov 19;13(11):e073983. doi: 10.1136/bmjopen-2023-073983.
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.
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 F-PSMA-1007 positron emission tomography/CT (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, F-PSMA-1007 PET/CT will be applied for further diagnosis. If patients are still considered as csPCa after 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.
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.
NCT05587192.
如今，前列腺穿刺活检是疑似前列腺癌（PCa）患者的标准诊断检测方法。然而，它存在一些缺点，如围手术期并发症、给患者带来的经济和心理负担，以及一些患者可能需要接受多次前列腺活检。在本研究方案中，我们的目的是提供一种非侵入性诊断策略，我们称之为“前列腺特异性膜抗原（PSMA）联合模型”，用于诊断 PCa。如果患者通过 PSMA 联合模型被诊断为 PCa，我们希望证明这些患者可以直接接受根治性前列腺切除术，而无需进行前列腺活检。
SNOTOB 试验采用前瞻性、单中心、单臂、开放标签研究设计。PSMA 联合模型由我们之前报道的诊断模型和串联的 F-PSMA-1007 正电子发射断层扫描/计算机断层扫描（F-PSMA-1007 PET/CT）检查组成。首先，患者使用诊断模型（在线网址：https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/）计算临床上显著前列腺癌（csPCa）的风险概率。当 csPCa 的风险概率等于或大于 0.60 时，将进行 F-PSMA-1007 PET/CT 进一步诊断。如果患者在 F-PSMA-1007 PET/CT 检查后仍被认为是 csPCa，我们将这种情况定义为 PSMA 联合模型的阳性结果。随后，我们将建议这些患者直接接受根治性前列腺切除术，而无需进行前列腺活检。最后，将通过病理结果验证 PSMA 联合模型的诊断性能。本临床试验共需入组 57 例患者。
本研究已获得中国科学技术大学附属第一医院伦理委员会的批准（编号：2022KY-142）。本研究的结果将发表在同行评议的期刊上，并在学术会议上报告。
NCT05587192。
Zotero 插件