Prostate‐specific membrane antigen (PSMA)‐targeted imaging and therapy of prostate cancer using theranostic pairs is rapidly changing clinical practice. To facilitate clinical trials, fully automated procedures for the radiosyntheses of [⁶⁸Ga]Ga‐PSMA‐11 and [¹⁷⁷Lu]Lu‐PSMA‐617 were developed from commercially available precursors using the cassette based iPHASE MultiSyn module. Formulated and sterile radiopharmaceuticals were obtained in 76 ± 3% (n = 20) and 91 ± 4% (n = 15) radiochemical yields after 17 and 20 min, respectively. Radiochemical purity was always >95% and molar activities exceeded 792 ± 100 and 88 ± 6 GBq/μmol, respectively. Quality control showed conformity with all relevant release criteria and radiopharmaceuticals were used in the clinic.

中文翻译：

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用于临床应用的 iPHASE MultiSyn 模块上 [68Ga]Ga-PSMA-11 和 [177Lu]Lu-PSMA-617 的自动放射合成

前列腺特异性膜抗原 (PSMA) 靶向成像和使用治疗诊断对治疗前列腺癌正在迅速改变临床实践。为了促进临床试验，[ ⁶⁸ Ga]Ga-PSMA-11 和 [ ¹⁷⁷ Lu]Lu-PSMA-617 的放射合成全自动程序是使用基于盒式的 iPHASE MultiSyn 模块从市售前体开发的。76 ± 3% ( n = 20) 和 91 ± 4% ( n= 15) 分别在 17 和 20 分钟后的放射化学产量。放射化学纯度始终 > 95%，摩尔活性分别超过 792 ± 100 和 88 ± 6 GBq/μmol。质量控制显示符合所有相关的释放标准，并且临床使用了放射性药物。