Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial
Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial
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DOI：
10.1001/jamaoncol.2019.0096
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发表时间：
2019-06-01
期刊：
影响因子：
28.4
通讯作者：
Hope, Thomas A.
中科院分区：
文献类型：
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作者：
Fendler, Wolfgang P.;Calais, Jeremie;Hope, Thomas A.
在回顾性研究中，与传统成像相比，Ga-68-PSMA-11正电子发射断层扫描（PET）成像提高了生化复发前列腺癌的检测。目的在一项前瞻性多中心试验中评估Ga-68-PSMA-11 PET的准确性。设计、环境和参与者：在加州大学旧金山分校和加州大学洛杉矶分校进行的这项单臂前瞻性试验中，635名前列腺切除术（n=262, 41%）、放射治疗（n=169, 27%）或两者同时进行（n=204, 32%）的生化复发前列腺癌患者接受了Ga-68-PSMA-11 PET检查。前列腺癌的存在由3名盲法读者记录在每个病人和每个地区的基础上。病变通过组织病理学分析和综合参考标准进行验证。主要结局和测量终点为阳性预测值（PPV）、检出率、解读器重现性和安全性。结果共纳入635名男性，中位年龄69岁（44-95岁）。在每个患者的基础上，组织病理学验证（主要终点，n=87）的PPV为0.84 (95% CI, 0.75-0.90)，复合参考标准（n=217）的PPV为0.92 （95% CI, 0.88-0.95）。635例（75%）患者中有475例Ga-68-PSMA-11 PET定位复发性前列腺癌；前列腺特异性抗原（PSA）的检出率显著提高：38%
ImportanceIn retrospective studies, Ga-68-PSMA-11 positron emission tomographic (PET) imaging improves detection of biochemically recurrent prostate cancer compared with conventional imaging. ObjectiveTo assess Ga-68-PSMA-11 PET accuracy in a prospective multicenter trial. Design, Setting, and ParticipantsIn this single-arm prospective trial conducted at University of California, San Francisco and University of California, Los Angeles, 635 patients with biochemically recurrent prostate cancer after prostatectomy (n=262, 41%), radiation therapy (n=169, 27%), or both (n=204, 32%) underwent Ga-68-PSMA-11 PET. Presence of prostate cancer was recorded by 3 blinded readers on a per-patient and per-region base. Lesions were validated by histopathologic analysis and a composite reference standard. Main Outcomes and MeasuresEndpoints were positive predictive value (PPV), detection rate, interreader reproducibility, and safety. ResultsA total of 635 men were enrolled with a median age of 69 years (range, 44-95 years). On a per-patient basis, PPV was 0.84 (95% CI, 0.75-0.90) by histopathologic validation (primary endpoint, n=87) and 0.92 (95% CI, 0.88-0.95) by the composite reference standard (n=217). Ga-68-PSMA-11 PET localized recurrent prostate cancer in 475 of 635 (75%) patients; detection rates significantly increased with prostate-specific antigen (PSA): 38% for