Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study
Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study
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DOI：
10.1016/s0140-6736(20)30314-7
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发表时间：
2020-04-11
期刊：
影响因子：
168.9
通讯作者：
Murphy, Declan G.
中科院分区：
文献类型：
--
作者：
Hofman, Michael S.;Lawrentschuk, Nathan;Murphy, Declan G.
背景：传统的CT和骨扫描成像在对高危局限性前列腺癌患者进行分期时灵敏度不足。我们的目的是调查是否新的成像使用前列腺特异性膜抗原（PSMA）PET-CT可能会提高准确性和影响management.Methods在这个多中心，双臂，随机研究，我们招募了男性活检证实的前列腺癌和高风险的功能在10家医院在澳大利亚。患者被随机分配到常规成像与CT和骨扫描或镓-68 PSMA-11 PET-CT。在随机化后21天内进行一线成像。患者交叉，除非发现3个或更多远处转移。主要结局是一线成像识别盆腔淋巴结或远处转移性疾病的准确性，该疾病由接受者-操作曲线定义，使用预定义的参考标准，包括6个月随访时的组织病理学、成像和生化。该试验已在澳大利亚新西兰临床试验登记处（ANZCTR 12617000005358）注册。结果从2017年3月22日至2018年11月2日，对339名男性进行了合格性评估，并随机分配了302名男性。152名（50%）男性被随机分配到常规成像组，150名（50%）男性被随机分配到PSMA PET-CT组。在295例（98%）随访男性中，87例（30%）有盆腔淋巴结或远处转移性疾病。PSMA PET-CT的准确性比常规成像高27%（95%CI 23-31）（92% [88-95] vs 65% [60-69]; p
Background Conventional imaging using CT and bone scan has insufficient sensitivity when staging men with high-risk localised prostate cancer. We aimed to investigate whether novel imaging using prostate-specific membrane antigen (PSMA) PET-CT might improve accuracy and affect management.Methods In this multicentre, two-arm, randomised study, we recruited men with biopsy-proven prostate cancer and high-risk features at ten hospitals in Australia. Patients were randomly assigned to conventional imaging with CT and bone scanning or gallium-68 PSMA-11 PET-CT. First-line imaging was done within 21 days following randomisation. Patients crossed over unless three or more distant metastases were identified. The primary outcome was accuracy of first-line imaging for identifying either pelvic nodal or distant-metastatic disease defined by the receiver-operating curve using a predefined reference-standard including histopathology, imaging, and biochemistry at 6-month follow-up. This trial is registered with the Australian New Zealand Clinical Trials Registry, ANZCTR12617000005358.Findings From March 22, 2017, to Nov 2, 2018, 339 men were assessed for eligibility and 302 men were randomly assigned. 152 (50%) men were randomly assigned to conventional imaging and 150 (50%) to PSMA PET-CT. Of 295 (98%) men with follow-up, 87 (30%) had pelvic nodal or distant metastatic disease. PSMA PET-CT had a 27% (95% CI 23-31) greater accuracy than that of conventional imaging (92% [88-95] vs 65% [60-69]; p