IMPORTANCE The presence of pelvic nodal metastases at radical prostatectomy is associated with biochemical recurrence after prostatectomy. OBJECTIVE To assess the accuracy of prostate-specific membrane antigen (PSMA) 68Ga-PSMA-11 positron emission tomographic (PET) imaging for the detection of pelvic nodal metastases compared with histopathology at time of radical prostatectomy and pelvic lymph node dissection. DESIGN, SETTING, AND PARTICIPANTS This investigator-initiated prospective multicenter single-arm open-label phase 3 imaging trial of diagnostic efficacy enrolled 764 patients with intermediate- to high-risk prostate cancer considered for prostatectomy at University of California, San Francisco and University of California, Los Angeles from December 2015 to December 2019. Data analysis took place from October 2018 to July 2021. INTERVENTIONS Imaging scan with 3 to 7 mCi of 68Ga-PSMA-11 PET. MAIN OUTCOMES AND MEASURES The primary end point was the sensitivity and specificity for the detection pelvic lymph nodes compared with histopathology on a per-patient basis using nodal region correlation. Each scan was read centrally by 3 blinded independent central readers, and a majority rule was used for analysis. RESULTS A total of 764 men (median [interquartile range] age, 69 [63-73] years) underwent 1 68Ga-PSMA-11 PET imaging scan for primary staging, and 277 of 764 (36%) subsequently underwent prostatectomy with lymph node dissection (efficacy analysis cohort). Based on pathology reports, 75 of 277 patients (27%) had pelvic nodal metastasis. Results of 68Ga-PSMA-11 PET were positive in 40 of 277 (14%), 2 of 277 (1%), and 7 of 277 (3%) of patients for pelvic nodal, extrapelvic nodal, and bone metastatic disease. Sensitivity, specificity, positive predictive value, and negative predictive value for pelvic nodal metastases were 0.40 (95% CI, 0.34-0.46), 0.95 (95% CI, 0.92-0.97), 0.75 (95% CI, 0.70-0.80), and 0.81 (95% CI, 0.76-0.85), respectively. Of the 764 patients, 487 (64%) did not undergo prostatectomy, of which 108 were lost to follow-up. Patients with follow-up instead underwent radiotherapy (262 of 379 [69%]), systemic therapy (82 of 379 [22%]), surveillance (16 of 379 [4%]), or other treatments (19 of 379 [5%]). CONCLUSIONS AND RELEVANCE This phase 3 diagnostic efficacy trial found that in men with intermediate- to high-risk prostate cancer who underwent radical prostatectomy and lymph node dissection, the sensitivity and specificity of 68Ga-PSMA-11 PET were 0.40 and 0.95, respectively. This academic collaboration is the largest known to date and formed the foundation of a New Drug Application for 68Ga-PSMA-11. TRIAL REGISTRATION ClinicalTrials.gov Identifiers: NCT03368547, NCT02611882, and NCT02919111.

中文翻译：

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68Ga-PSMA-11 PET 用于根治性前列腺切除术和盆腔淋巴结清扫术前盆腔淋巴结转移检测的诊断准确性：一项多中心前瞻性 3 期成像试验。

重要性 根治性前列腺切除术中盆腔淋巴结转移的存在与前列腺切除术后的生化复发有关。目的 评估前列腺特异性膜抗原 (PSMA) 68Ga-PSMA-11 正电子发射断层扫描 (PET) 成像与根治性前列腺切除术和盆腔淋巴结清扫术时的组织病理学相比检测盆腔淋巴结转移的准确性。设计、地点和参与者 这项由研究者发起的前瞻性多中心单臂开放标签 3 期诊断效果影像学试验在加州大学旧金山分校和加州大学招募了 764 名考虑进行前列腺切除术的中高危前列腺癌患者。加利福尼亚州洛杉矶，2015 年 12 月至 2019 年 12 月。数据分析于 2018 年 10 月至 2021 年 7 月进行。干预 使用 3 至 7 mCi 的 68Ga-PSMA-11 PET 进行成像扫描。主要结果和测量 主要终点是检测盆腔淋巴结的敏感性和特异性，与每个患者的组织病理学相比，使用淋巴结区域相关性。每个扫描由 3 位盲法独立中央阅读器集中阅读，并使用多数规则进行分析。结果 共有 764 名男性（中位 [四分位间距] 年龄，69 [63-73] 岁）接受了 1 次 68Ga-PSMA-11 PET 成像扫描以进行初步分期，764 人中有 277 人 (36%) 随后接受了淋巴结前列腺切除术解剖（功效分析队列）。根据病理报告，277 例患者中有 75 例（27%）发生盆腔淋巴结转移。68Ga-PSMA-11 PET 结果在 277 名患者中有 40 名 (14%)、277 名患者中有 2 名 (1%) 和 277 名患者中有 7 名 (3%) 为盆腔淋巴结阳性，骨盆外淋巴结和骨转移性疾病。盆腔淋巴结转移的敏感性、特异性、阳性预测值和阴性预测值分别为 0.40（95% CI，0.34-0.46）、0.95（95% CI，0.92-0.97）、0.75（95% CI，0.70-0.80）、和 0.81（95% CI，0.76-0.85）。在 764 名患者中，487 名 (64%) 未接受前列腺切除术，其中 108 名失访。接受随访的患者改为接受放疗（379 人中的 262 人 [69%]）、全身治疗（379 人中的 82 人 [22%]）、监测（379 人中的 16 人 [4%]）或其他治疗（379 人中的 19 [5] %]). 结论和相关性 该 3 期诊断功效试验发现，在接受根治性前列腺切除术和淋巴结清扫术的中高风险前列腺癌男性中，68Ga-PSMA-11 PET 的敏感性和特异性分别为 0.40 和 0.95。该学术合作是迄今为止已知的最大合作，并为 68Ga-PSMA-11 的新药申请奠定了基础。试验注册 ClinicalTrials.gov 标识符：NCT03368547、NCT02611882 和 NCT02919111。