ImportanceProstate-specific membrane antigen (PSMA) demonstrates overexpression in prostate cancer and correlates with tumor aggressiveness. PSMA positron emission tomography (PET) is superior to conventional imaging for the metastatic staging of prostate cancer per current research but studies of second-generation PSMA PET radioligands for locoregional staging are limited.ObjectiveTo determine the accuracy of fluorine-18 PSMA-1007 PET/computed tomography (18F-PSMA-1007 PET/CT) compared to multiparametric magnetic resonance imaging (MRI) in the primary locoregional staging of intermediate-risk and high-risk prostate cancers.Design, Setting, and ParticipantsThe Next Generation Trial was a phase 2 prospective validating paired cohort study assessing the accuracy of 18F-PSMA-1007 PET/CT and MRI for locoregional staging of prostate cancer, with results of histopathologic examination as the reference standard comparator. Radiologists, nuclear medicine physicians, and pathologists were blinded to preoperative clinical, pathology, and imaging data. Patients underwent all imaging studies and radical prostatectomies at 2 tertiary care hospitals in Alberta, Canada. Eligible participants included men with intermediate-risk or high-risk prostate cancer who consented to radical prostatectomy. Participants who underwent radical prostatectomy were included in the final analysis. Patients were recruited between March 2022 and June 2023, and data analysis occurred between July 2023 and December 2023.ExposuresAll participants underwent both 18F-PSMA-1007 PET/CT and MRI within 2 weeks of one another and before radical prostatectomy.Main Outcomes and MeasuresThe primary outcome was the correct identification of the prostate cancer tumor stage by each imaging test. The secondary outcomes were correct identification of the dominant nodule, laterality, extracapsular extension, and seminal vesical invasion.ResultsOf 150 eligible men with prostate cancer, 134 patients ultimately underwent radical prostatectomy (mean [SD] age at prostatectomy, 62.0 [5.7] years). PSMA PET was superior to MRI for the accurate identification of the final pathological tumor stage (61 [45%] vs 38 [28%]; P = .003). PSMA PET was also superior to MRI for the correct identification of the dominant nodule (126 [94%] vs 112 [83%]; P = .01), laterality (86 [64%] vs 60 [44%]; P = .001), and extracapsular extension (100 [75%] vs 84 [63%]; P = .01), but not for seminal vesicle invasion (122 [91%] vs 115 [85%]; P = .07).Conclusions and RelevanceIn this phase 2 prospective validating paired cohort study, 18F-PSMA-1007 PET/CT was superior to MRI for the locoregional staging of prostate cancer. These findings support PSMA PET in the preoperative workflow of intermediate-risk and high-risk tumors.

中文翻译：

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氟 18 前列腺特异性膜抗原 – 1007 PET/CT 与多参数 MRI 用于前列腺癌局部分期


重要性前列腺特异性膜抗原 (PSMA) 在前列腺癌中过度表达，并与肿瘤侵袭性相关。根据目前的研究，PSMA 正电子发射断层扫描 (PET) 在前列腺癌转移分期方面优于传统成像，但用于局部分期的第二代 PSMA PET 放射性配体的研究有限。 目的确定氟 18 PSMA-1007 PET/计算机断层扫描（ 18 F-PSMA-1007 PET/CT）与多参数磁共振成像（MRI）在中危和高危前列腺癌的主要局部分期中的比较。设计、设置和参与者下一代试验是一项 2 期前瞻性验证配对试验队列研究评估准确性18 F-PSMA-1007 PET/CT和MRI用于前列腺癌局部分期，以组织病理学检查结果作为参考标准比较。放射科医生、核医学医生和病理学家对术前临床、病理和影像数据不知情。患者在加拿大艾伯塔省的两家三级医院接受了所有影像学检查和根治性前列腺切除术。符合资格的参与者包括同意接受根治性前列腺切除术的中危或高危前列腺癌男性。接受根治性前列腺切除术的参与者被纳入最终分析。患者于 2022 年 3 月至 2023 年 6 月期间招募，数据分析于 2023 年 7 月至 2023 年 12 月期间进行。 18 F-PSMA-1007 PET/CT 和 MRI 分别在 2 周内且在根治性前列腺切除术之前进行。主要结果和措施主要结果是通过每次成像测试正确识别前列腺癌肿瘤分期。次要结果是正确识别主要结节、偏侧性、囊外扩展和精囊侵犯。结果在 150 名符合条件的前列腺癌男性中，134 名患者最终接受了根治性前列腺切除术（前列腺切除术时的平均 [SD] 年龄为 62.0 [5.7] 岁） 。 PSMA PET 在准确识别最终肿瘤病理分期方面优于 MRI（61 [45%] vs 38 [28%]；磷=.003）。在正确识别主要结节方面，PSMA PET 也优于 MRI（126 [94%] vs 112 [83%]；磷= .01)，偏侧性（86 [64%] vs 60 [44%]；磷= .001) 和囊外延伸 (100 [75%] vs 84 [63%]；磷= .01），但不适用于精囊侵犯（122 [91%] vs 115 [85%]；磷= .07)。结论和相关性在这项 2 期前瞻性验证配对队列研究中， 18 F-PSMA-1007 PET/CT 在前列腺癌的局部分期方面优于 MRI。这些发现支持 PSMA PET 在中危和高危肿瘤的术前工作流程中的应用。