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

The clinical utility of gallium 68 (68Ga)-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 68Ga-PSMA: 68Ga-PSMA-cyclotron (from a solid target) and 68Ga-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 68Ga-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 68Ga-cyclotron (solid target) and 68Ga-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 68Ga can be made in large (Ci) quantities, it is a promising tool for future application in 68Ga-PSMA PET scans with the potential to decrease radiotracer production costs and in-crease isotope availability.

Automated summary

This study evaluates the equivalence between two manufacturing processes for 68Ga-PSMA: 68Ga-PSMA-cyclotron and 68Ga-PSMA-generator. The results suggest that both methods yield similar results in detecting PSMA+ lesions, indicating the potential of cyclotron-produced 68Ga-PSMA for large-scale production, cost reduction, and increased availability of the radioisotope for future use.