Automated synthesis of 68Ga/177Lu‐PSMA on the Trasis miniAllinOne

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). [ 68 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 [ 68 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 [ 177 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.