Department of Nuclear Medicine, University Hospital of Cologne, Cologne, Germany
Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.
J Nucl Med. 2020 Feb;61(2):202-209. doi: 10.2967/jnumed.119.229542. Epub 2019 Jul 19.
In preclinical trials, the recently developed tracer 2-methoxy-F-DCFPyL (F-JK-prostate-specific membrane antigen [PSMA]-7) has shown favorable properties regarding clinical performance and radiochemical accessibility. The aim of this study was to evaluate the clinical utility of F-JK-PSMA-7 for PET/CT imaging of patients with prostate cancer. In an Institutional Review Board-approved pilot study, the initial clinical utility of PET/CT imaging with F-JK-PSMA-7 was directly compared with Ga-PSMA-11 PET/CT in a group of 10 patients with prostate cancer. The 2 PSMA tracers were administered to each patient less than 3 wk apart. Next, we analyzed the data of 75 consecutive patients who had undergone clinical F-JK-PSMA-7 PET/CT imaging for tumor localization of biochemical recurrence (BCR). The pilot study in 10 patients who were examined with both PSMA tracers demonstrated that F-JK-PSMA-7 was at least equivalent to Ga-PSMA-11. All unequivocally Ga-PSMA-11-positive lesions could be also detected using F-JK-PSMA-7, and in 4 patients additional suspected PSMA-positive lesions were identified (1 patient changed from PSMA-negative to PSMA-positive). In patients with BCR (after prostatectomy or radiotherapy), the capacity of F-JK-PSMA-7 PET/CT to detect at least one PSMA-positive lesion was 84.8%. The prostate-specific antigen (PSA)-stratified detection rate of F-JK-PSMA-7 after prostatectomy varied among 54.5% (6/11 patients; PSA < 0.5 μg/L), 87.5% (14/16 patients; PSA 0.5-2 μg/L), and 90.9% (20/22 patients; PSA > 2 μg/L). The tracer F-JK-PSMA-7 was found to be safe and clinically useful. We demonstrated that F-JK-PSMA-7 was not inferior when directly compared with Ga-PSMA-11 in a pilot study but indeed identified additional PSMA-avid suspected lesions in oligometastasized patients with BCR. In a subsequent analysis of a clinical cohort of BCR patients, F-JK-PSMA-7 was useful in tumor localization. F-JK-PSMA-7 is recommended for future prospective trials.
在临床前试验中，最近开发的示踪剂 2-甲氧基-F-DCFPyL（F-JK-前列腺特异性膜抗原[PSMA]-7）在临床性能和放射化学可及性方面表现出良好的特性。本研究旨在评估 F-JK-PSMA-7 用于前列腺癌患者 PET/CT 成像的临床实用性。 在一项机构审查委员会批准的试点研究中，将 F-JK-PSMA-7 的 PET/CT 成像的初始临床实用性与 Ga-PSMA-11 PET/CT 在一组 10 例前列腺癌患者中直接进行比较。两种 PSMA 示踪剂在不到 3 周的时间内分别给予每位患者。接下来，我们分析了 75 例连续接受 F-JK-PSMA-7 PET/CT 临床成像以定位生化复发（BCR）的患者的数据。 在接受两种 PSMA 示踪剂检查的 10 例患者的试点研究表明，F-JK-PSMA-7 至少与 Ga-PSMA-11 相当。所有明确的 Ga-PSMA-11 阳性病变都可以用 F-JK-PSMA-7 检测到，并且在 4 例患者中还发现了其他疑似 PSMA 阳性病变（1 例从 PSMA 阴性变为 PSMA 阳性）。在 BCR（前列腺切除术或放疗后）患者中，F-JK-PSMA-7 PET/CT 检测至少一个 PSMA 阳性病变的能力为 84.8%。前列腺特异性抗原（PSA）分层后，前列腺切除术患者中 F-JK-PSMA-7 的检测率为 54.5%（6/11 例患者；PSA<0.5μg/L）、87.5%（14/16 例患者；PSA 0.5-2μg/L）和 90.9%（22/22 例患者；PSA>2μg/L）。 研究结果表明，F-JK-PSMA-7 是安全且具有临床应用价值的。我们证明，在一项试点研究中，当与 Ga-PSMA-11 直接比较时，F-JK-PSMA-7 并不差，但实际上在 BCR 寡转移患者中确实发现了其他 PSMA 阳性疑似病变。在随后对 BCR 患者的临床队列进行的分析中，F-JK-PSMA-7 对肿瘤定位有用。建议将 F-JK-PSMA-7 用于未来的前瞻性试验。
