使用经病理组织学评估的扩展盆腔淋巴结清扫术作为参考，对新诊断的中高危前列腺癌患者进行氟-18 前列腺特异性膜抗原 1007-正电子发射断层扫描/计算机断层扫描进行淋巴结分期。
Lymph node staging with fluorine-18 prostate specific membrane antigen 1007-positron emission tomography/computed tomography in newly diagnosed intermediate- to high-risk prostate cancer using histopathological evaluation of extended pelvic node dissection as reference.
机构信息
Department of Nuclear Medicine, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands.
Department of Urology, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands.
出版信息
Eur J Nucl Med Mol Imaging. 2022 Sep;49(11):3929-3937. doi: 10.1007/s00259-022-05827-4. Epub 2022 May 11.
PURPOSE
Fluorine-18 (F) prostate-specific membrane antigen (PSMA) 1007 (F-PSMA-1007) is a radiotracer used in prostate cancer (PCa) staging. So far, no large histopathological validation study has been conducted. The objective was to determine diagnostic accuracy of F-PSMA-1007 PET/CT compared to histopathological results of extended pelvic lymph node dissection (ePLND) in men with intermediate- or high-risk PCa.
METHODS
Men with newly confirmed intermediate- or high-risk PCa were prospectively enrolled in the Molecular Imaging F-PSMA-1007 PET/CT for lymph Node sTaging in primary PCa (MINT) trial. PET/CT images were read by two nuclear medicine physicians. Diagnostic accuracy was evaluated by histopathology of template resections. Sensitivity, specificity, and positive and negative predictive values (PPV, NPV) for LNI detection of F-PSMA-1007 PET/CT were calculated.
RESULTS
Ninety-nine men were evaluated; 30.3% showed histologically confirmed LNI. Median number of resected nodes was 22 (IQR 17-28). Patient-based sensitivity, specificity, PPV, and NPV were 53.3% (95% CI 34.3-71.7%), 89.9% (95% CI 80.2-95.8%), 69.6% (95% CI 51.2-83.3%), and 81.6% (95% CI 75.0-86.8%), respectively. Template-based sensitivity was 12.9% (95% CI 5.7-23.9%), specificity 97.7% (95% CI 96.6-98.5%), PPV 23.5% (95% CI 12.7-39.5%), and NPV 95.3% (95% CI 94.9-95.7%).
CONCLUSION
F-PSMA-1007 PET/CT showed high specificity but moderate to low sensitivity for LNI detection in intermediate- and high-risk PCa. It cannot replace ePLND for staging. Additional studies are needed to determine exact scan indications in lymph node staging for the primary diagnostic pathway in intermediate- or high-risk PCa.
TRIAL REGISTRY
December 12, 2018, Netherlands Trial Registry, NTR7670 ( https://www.trialregister.nl/trial/7428 ).
目的
氟-18（F）前列腺特异性膜抗原（PSMA）1007（F-PSMA-1007）是一种用于前列腺癌（PCa）分期的放射性示踪剂。到目前为止，还没有进行过大规模的组织病理学验证研究。本研究的目的是确定 F-PSMA-1007 PET/CT 与中高危 PCa 患者的扩大盆腔淋巴结清扫术（ePLND）的组织病理学结果相比，在检测局部淋巴结转移（LNI）方面的诊断准确性。
方法
新确诊为中高危 PCa 的男性前瞻性纳入分子影像学 F-PSMA-1007 PET/CT 用于原发性 PCa 的淋巴结分期（MINT）试验。核医学医师对 PET/CT 图像进行了阅读。通过模板切除的组织病理学来评估诊断准确性。计算 F-PSMA-1007 PET/CT 检测 LNI 的敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）。
结果
99 名男性接受了评估；30.3%的患者组织学证实有 LNI。中位数切除的淋巴结数为 22 个（IQR 17-28）。基于患者的敏感性、特异性、PPV 和 NPV 分别为 53.3%（95%CI 34.3-71.7%）、89.9%（95%CI 80.2-95.8%）、69.6%（95%CI 51.2-83.3%）和 81.6%（95%CI 75.0-86.8%）。基于模板的敏感性为 12.9%（95%CI 5.7-23.9%），特异性为 97.7%（95%CI 96.6-98.5%），PPV 为 23.5%（95%CI 12.7-39.5%），NPV 为 95.3%（95%CI 94.9-95.7%）。
结论
F-PSMA-1007 PET/CT 对中高危 PCa 的 LNI 检测具有高特异性，但敏感性为中低水平。它不能替代 ePLND 进行分期。需要进一步研究来确定在中高危 PCa 的原发性诊断途径中，在淋巴结分期方面的准确扫描适应证。
试验注册
2018 年 12 月 12 日，荷兰试验注册处，NTR7670（https://www.trialregister.nl/trial/7428）。
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