Feasibility and Safety of 68Ga-PSMA-11 PET/CT Using Cyclotron-Produced 68Ga in Patients with Prostate Cancer

Abstract

Abstract Objectives This study evaluated the feasibility and safety of 68 Ga-PSMA-11 PET/CT using an in-house cyclotron-produced 68 Ga in patients with prostate cancer. Methods We prospectively included 10 patients across clinically relevant disease settings: biochemical recurrence after definitive local therapy, non-metastatic castration-resistant prostate cancer, and metastatic castration-resistant prostate cancer. 68 Ga was produced using a cyclotron-based method and radiolabeled with PSMA-11 under standardized conditions. All patients underwent PET/CT imaging after tracer administration. The primary endpoint was safety, which was assessed by monitoring adverse events during and after the tracer injection. The secondary endpoints included the feasibility of radiotracer production, image acquisition, and qualitative assessment of lesion detectability. Results All procedures were successfully completed without technical failures. A total of 10 clinical production batches were manufactured for 11 patients, corresponding to a clinical production success rate of 100% (10/10). The amount of produced 68Ga-PSMA-11 ranged from 0.63 to 2.83 GBq, with a mean activity of approximately 1.69 GBq per batch. All production batches met predefined quality control specifications, including radiochemical purity requirements, and no batch was rejected for clinical use. No adverse events, clinically significant changes in general conditions or vital signs were observed. Cyclotron-based production of 68 Ga provided a stable radiotracer yield and enabled timely imaging. PET/CT clearly visualized PSMA-avid lesions across different disease states. Conclusions 68 Ga-PSMA-11 PET/CT imaging using an in-house cyclotron-produced 68 Ga is a feasible and safe diagnostic modality for prostate cancer. This study demonstrates the feasibility and safety of implementing cyclotron-produced 68Ga-PSMA-11 PET/CT in routine clinical practice.