The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Maryland.
J Urol. 2021 Jul;206(1):52-61. doi: 10.1097/JU.0000000000001698. Epub 2021 Feb 26.
Prostate specific membrane antigen-targeted positron emission tomography/computerized tomography has the potential to improve the detection and localization of prostate cancer. OSPREY was a prospective trial designed to determine the diagnostic performance of F-DCFPyL-positron emission tomography/computerized tomography for detecting sites of metastatic prostate cancer.
Two patient populations underwent F-DCFPyL-positron emission tomography/computerized tomography. Cohort A enrolled men with high-risk prostate cancer undergoing radical prostatectomy with pelvic lymphadenectomy. Cohort B enrolled patients with suspected recurrent/metastatic prostate cancer on conventional imaging. Three blinded central readers evaluated the F-DCFPyL-positron emission tomography/computerized tomography. Diagnostic performance of F-DCFPyL-positron emission tomography/computerized tomography was based on imaging results compared to histopathology. In cohort A, detection of pelvic nodal disease (with specificity and sensitivity as co-primary end points) and of extrapelvic metastases were evaluated. In cohort B, sensitivity and positive predictive value for prostate cancer within biopsied lesions were evaluated.
A total of 385 patients were enrolled. In cohort A (252 evaluable patients), F-DCFPyL-positron emission tomography/computerized tomography had median specificity of 97.9% (95% CI: 94.5%-99.4%) and median sensitivity of 40.3% (28.1%-52.5%, not meeting prespecified end point) among 3 readers for pelvic nodal involvement; median positive predictive value and negative predictive value were 86.7% (69.7%-95.3%) and 83.2% (78.2%-88.1%), respectively. In cohort B (93 evaluable patients, median prostate specific antigen 11.3 ng/ml), median sensitivity and positive predictive value for extraprostatic lesions were 95.8% (87.8%-99.0%) and 81.9% (73.7%-90.2%), respectively.
The primary end point for specificity was met while the primary end point for sensitivity was not. The high positive predictive value observed in both cohorts indicates that F-DCFPyL-positive lesions are likely to represent disease, supporting the potential utility of F-DCFPyL-positron emission tomography/computerized tomography to stage men with high-risk prostate cancer for nodal or distant metastases, and reliably detect sites of disease in men with suspected metastatic prostate cancer.
前列腺特异性膜抗原靶向正电子发射断层扫描/计算机断层扫描有可能提高前列腺癌的检测和定位能力。OSPREY 是一项前瞻性试验，旨在确定 F-DCFPyL 正电子发射断层扫描/计算机断层扫描对检测转移性前列腺癌部位的诊断性能。
两组患者均接受了 F-DCFPyL 正电子发射断层扫描/计算机断层扫描。队列 A 纳入了接受根治性前列腺切除术和盆腔淋巴结清扫术的高危前列腺癌患者。队列 B 纳入了在常规影像学检查中疑似复发/转移性前列腺癌的患者。三名盲法中心读者评估了 F-DCFPyL 正电子发射断层扫描/计算机断层扫描。F-DCFPyL 正电子发射断层扫描/计算机断层扫描的诊断性能基于与组织病理学的影像学结果比较。在队列 A 中，评估了盆腔淋巴结疾病（特异性和敏感性作为共同主要终点）和盆腔外转移的检测。在队列 B 中，评估了在活检病变中前列腺癌的敏感性和阳性预测值。
共纳入 385 例患者。在队列 A（252 例可评估患者）中，F-DCFPyL 正电子发射断层扫描/计算机断层扫描在 3 名读者中，对于盆腔淋巴结受累，中位特异性为 97.9%（95%CI：94.5%-99.4%），中位敏感性为 40.3%（28.1%-52.5%，未达到预设终点）；中位阳性预测值和阴性预测值分别为 86.7%（69.7%-95.3%）和 83.2%（78.2%-88.1%）。在队列 B（93 例可评估患者，中位前列腺特异性抗原 11.3ng/ml）中，对于前列腺外病变，中位敏感性和阳性预测值分别为 95.8%（87.8%-99.0%）和 81.9%（73.7%-90.2%）。
特异性的主要终点达到，而敏感性的主要终点未达到。在两个队列中观察到的高阳性预测值表明，F-DCFPyL 阳性病变很可能代表疾病，这支持 F-DCFPyL 正电子发射断层扫描/计算机断层扫描在高危前列腺癌患者中用于淋巴结或远处转移分期的潜在效用，并可靠地检测可疑转移性前列腺癌患者的疾病部位。
