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Abstract：
18F-rhPSMA-7.3 (18F-flotufolastat) is a high-affinity prostate-specific membrane antigen-targeted diagnostic radiopharmaceutical for PET imaging in patients with prostate cancer. Here, we report findings from the SPOTLIGHT study (NCT04186845), assessing the performance of 18F-flotufolastat PET/CT for identifying prostate-specific membrane antigen-positive lesions confirmed by standard of truth (SoT) in men with biochemical recurrence of prostate cancer and negative conventional imaging at baseline. Methods: Men with biochemical recurrence received 296 MBq of 18F-flotufolastat intravenously and then underwent PET/CT 50-70 min later. 18F-flotufolastat PET/CT findings were evaluated by 3 masked central readers and verified using histopathology or follow-up confirmatory imaging (CT, MRI, bone scan, or 18F-fluciclovine PET/CT) as the SoT. The present analysis evaluated all patients who had negative conventional imaging at baseline, underwent 18F-flotufolastat PET/CT, and had SoT verification by histopathology or follow-up confirmatory imaging to report detection rate (DR), which is the number of patients with at least 1 PET-positive lesion, divided by the number of evaluable patients, and verified DR (VDR), which is the proportion of patients with at least 1 true-positive lesion as verified by SoT, of all patients scanned (PET-positive and PET-negative scans). DR and VDR were calculated and stratified according to prior therapy. Majority read data (agreement between ≥2 readers) are reported. Results: In total, 171 patients with negative baseline conventional imaging and SoT by histopathology or post-PET confirmatory imaging were evaluated. By majority read, the overall 18F-flotufolastat DR among these patients was 95% (163/171; 95% CI, 91.0%-98.0%), and 110 of 171 of these patients had at least 1 true-positive lesion identified (VDR, 64%; 95% CI, 56.7%-71.5%). In the postprostatectomy group (133/171), 8.3% of patients had at least 1 true-positive lesion in the prostate bed, 28% in pelvic lymph nodes, and 35% in other sites. Among those who had received radiotherapy (36/171), 50% of patients had true-positive detections in the prostate, 8.3% in pelvic lymph nodes, and 36% in other sites. Conclusion: 18F-flotufolastat frequently identified true-positive prostate cancer lesions in patients with negative conventional imaging. 18F-flotufolastat may help to better define sites of disease recurrence and inform salvage therapy decisions than does conventional imaging, potentially leading to improved outcomes.
摘要：
18F-rhPSMA-7.3（18F-flotufolastat）是一种高亲和力前列腺特异性膜抗原靶向诊断放射性药物，用于前列腺癌患者的PET成像。这里,我们报告了SPOTLIGHT研究(NCT04186845)的发现，评估18F-flofufolastatPET/CT在鉴别经真实标准(SoT)证实的前列腺特异性膜抗原阳性病变方面的表现,治疗基线时前列腺癌生化复发且常规成像阴性的男性患者.方法：生化复发的男性静脉接受296MBq的18F-氟尿司他，然后在50-70分钟后进行PET/CT检查。18F-flotufolastatPET/CT检查结果由3名蒙面的中央阅读器进行评估，并使用组织病理学或随访证实的影像学检查（CT，MRI,骨扫描,或18F-fluciclovinePET/CT）作为SoT。本分析评估了所有基线常规影像学检查阴性的患者，接受18F-flofuolastatPET/CT，并通过组织病理学或随访证实性成像进行SoT验证以报告检出率（DR），即至少有1个PET阳性病灶的患者数量，除以可评估患者的数量，和验证DR(VDR)，这是由SoT验证的至少1个真阳性病变的患者比例，所有患者扫描（PET阳性和PET阴性扫描）。根据治疗前计算DR和VDR并分层。报告多数阅读数据（≥2个读者之间的协议）。结果：总的来说，通过组织病理学或PET证实后成像对171例基线常规成像和SoT阴性的患者进行了评估。大多数人阅读，这些患者的总体18F-flofufolastatDR为95％（163/171；95％CI，91.0％-98.0％），171例患者中的110例至少有1例真阳性病变(VDR，64%；95%CI，56.7%-71.5%）。在前列腺切除术后组（133/171），8.3%的患者在前列腺床上有至少1个真阳性病变，28％在盆腔淋巴结，35%在其他网站。在接受放射治疗的人中（36/171），50%的患者前列腺检测结果为真阳性,8.3%在盆腔淋巴结，其他网站占36%。结论：在常规影像学检查阴性的患者中，18F-flofufolastat经常能识别真阳性前列腺癌病变。18F-flotufolastat可能有助于更好地定义疾病复发的部位，并告知抢救治疗决策比传统成像，可能导致结果的改善。
