18F-DCFPyL (2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid), a prostate-specific membrane antigen-targeting radiotracer, has shown promise as a prostate cancer imaging radiotracer. We evaluated the safety, sensitivity, and impact on patient management of 18F-DCFPyL in the setting of biochemical recurrence of prostate cancer. Methods: Subjects with prostate cancer and biochemical recurrence after radical prostatectomy or curative-intent radiotherapy were included in this prospective study. The subjects underwent 18F-DCFPyL PET/CT imaging. The localization and number of lesions were recorded. The uptake characteristics of the 5 most active lesions were measured. A pre- and posttest questionnaire was sent to treating physicians to assess the impact on management. Results: One hundred thirty subjects were evaluated. 18F-DCFPyL PET/CT localized recurrent prostate cancer in 60% of cases with a prostate-specific antigen (PSA) level of ≥0.4 to <0.5, 78% with a level of ≥0.5 to <1.0, 72% with a level of ≥1.0 to <2.0, and 92% with a level of ≥2.0. Many subjects had few lesions (1 lesion in 40.8%, 2 in 8.5%, and 3 in 4.6%). The number of lesions was significantly related to PSA by ANOVA, but there was a large overlap in the PSA values for number of lesion categories. Total lesion uptake was also significantly related to PSA level. A change in treatment intent occurred in 65.5% of subjects, disease stage changed in 65.5%, and management plans changed in 87.3%. Twenty-two subjects reported mild adverse events after the scan; all resolved completely. Conclusion: 18F-DCFPyL PET/CT is safe and sensitive for the localization of biochemical recurrence of prostate cancer. This test improved decision making for referring oncologists and changed management for most subjects.

中文翻译：

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18F-DCFPyL PSMA PET / CT成像在前列腺癌生化复发中的前瞻性研究。

18F-DCFPyL（2-（3- {1-羧基-5-[（6-18F-氟-吡啶-3-羰基）-氨基]-戊基}-脲基）-戊二酸），前列腺特异性膜抗原靶向放射性示踪剂已显示出作为前列腺癌成像放射性示踪剂的希望。我们评估了18F-DCFPyL在前列腺癌生化复发中的安全性，敏感性以及对患者管理的影响。方法：该前瞻性研究包括前列腺癌根治性前列腺切除术或根治性放疗后发生前列腺癌且生化复发的受试者。受试者接受了18F-DCFPyL PET / CT成像。记录病变的位置和数量。测量了5个最活跃的病变的摄取特征。测试前和测试后的问卷已发送给主治医生，以评估对管理的影响。结果：对一百三十名受试者进行了评估。18F-DCFPyL PET / CT在60％≥0.4至<0.5的前列腺特异性抗原（PSA）病例，≥≥0.5至<1.0的78％病例，≥0.5的72％病例中局限性复发性前列腺癌≥1.0到<2.0，以及92％的水平≥2.0。许多受试者的病灶很少（1个病灶占40.8％，2个病灶占8.5％，3个病灶占4.6％）。通过ANOVA，病变的数量与PSA显着相关，但是在病变类别数量上，PSA值存在很大的重叠。总病灶摄取也与PSA水平显着相关。65.5％的受试者发生了治疗意图的改变，疾病阶段改变了65.5％，管理计划改变了87.3％。扫描后有22名受试者报告了轻度不良事件。一切都彻底解决了。结论：18F-DCFPyL PET / CT对于前列腺癌生化复发的定位是安全和敏感的。该测试改进了转介肿瘤科医生的决策，并改变了大多数受试者的管理方式。