Department of Nuclear Medicine, Copenhagen University Hospital Herlev and Gentofte, Herlev, Denmark.
Department of Research and Development, Trasis Radiopharmacy Instruments, Ans, Belgium.
J Labelled Comp Radiopharm. 2020 Jun 30;63(8):393-403. doi: 10.1002/jlcr.3846. Epub 2020 Jun 1.
Prostate-specific membrane antigen (PSMA)-based radioligands for positron emission tomography (PET)/computed tomography (CT) studies represent the gold standard for detection of recurrent prostate cancer (PCa). [ Ga]PSMA-HBED-CC is a PET radiotracer suitable for detection of PCa, and its clinical use has become widespread over the last few years. In this contribution, we detail our GMP-compliant production of [ Ga]PSMA-HBED-CC using the Trasis miniAllinOne radiosynthesizer and report synthetic and clinical data for the first 100 productions of 2019. Additionally, we detail our efforts towards a GMP-compliant production of the radiotherapeutic [ Lu]PSMA-I&T using the same synthesis module. PSMA-based radioligand therapy (RLT) offers a possible future treatment in cases of metastatic castration-resistant PCa, and GMP-compliant routine production methods are therefore called for. This report highlights how PSMA-based agents for theranostic purposes can be conveniently produced at a single radiochemistry Good Manufacturing Practice (GMP) site, thereby facilitating optimized detection and treatment of PCa.
前列腺特异性膜抗原（PSMA）为基础的放射性配体正电子发射断层扫描（PET）/计算机断层扫描（CT）研究代表了检测复发性前列腺癌（PCa）的金标准。[Ga]PSMA-HBED-CC 是一种适用于检测 PCa 的 PET 放射性示踪剂，近年来其临床应用已广泛普及。在本研究中，我们详细介绍了使用 Trasis miniAllinOne 放射性合成仪进行符合 GMP 要求的[Ga]PSMA-HBED-CC 生产，并报告了 2019 年首次生产的 2019 次生产的合成和临床数据。此外，我们详细介绍了使用相同的合成模块进行符合 GMP 要求的放射性治疗[Lu]PSMA-I&T 的生产工作。基于 PSMA 的放射性配体治疗（RLT）为转移性去势抵抗性 PCa 提供了一种可能的未来治疗方法，因此需要符合 GMP 的常规生产方法。本报告强调了如何在单个放射化学良好生产规范（GMP）站点方便地生产用于治疗目的的 PSMA 基制剂，从而促进了 PCa 的优化检测和治疗。
