Cyclotron vs generator-produced 68Ga PSMA: a single-institution, prospective clinical trial

The clinical utility of gallium 68 ((68)Ga)-PSMA PET for the diagnosis and management of prostate cancer is driven in part by radioisotope availability and production costs. This study evaluates the equivalence between the two manufacturing processes for (68)Ga-PSMA: (68)Ga-PSMA-cyclotron (from a solid target) and (68)Ga-PSMA-generator. A prospective, single-arm, single-institution non-randomized study was conducted where 16 patients with prostate adenocarcinoma underwent PET/CTs consecutively within 12 to 48 hours with each type of manufactured (68)Ga-PSMA between December 2020 and June 2021. The intraclass correlation coefficients suggested acceptable reliability in all lesion parameters (ICC > 0.70). Bland-Altman analysis demonstrated acceptable bias levels for all lesion parameters. Thereby (68)Ga-cyclotron (solid target) and (68)Ga-generator production methods tagged to the same PSMA ligand resulted in scans which were deemed to be equivalent in detecting PSMA+ lesions in our study. As cyclotron-produced, solid- target (68)Ga can be made in large (Ci) quantities, it is a promising tool for future application in (68)Ga-PSMA PET scans with the potential to decrease radiotracer production costs and increase isotope availability.