An F-Labeled PSMA Ligand for PET/CT of Prostate Cancer: First-in-Humans Observational Study and Clinical Experience with F-JK-PSMA-7 During the First Year of Application.

In preclinical trials, the recently developed tracer 2-methoxy-F-DCFPyL (F-JK-prostate-specific membrane antigen [PSMA]-7) has shown favorable properties regarding clinical performance and radiochemical accessibility. The aim of this study was to evaluate the clinical utility of F-JK-PSMA-7 for PET/CT imaging of patients with prostate cancer. In an Institutional Review Board-approved pilot study, the initial clinical utility of PET/CT imaging with F-JK-PSMA-7 was directly compared with Ga-PSMA-11 PET/CT in a group of 10 patients with prostate cancer. The 2 PSMA tracers were administered to each patient less than 3 wk apart. Next, we analyzed the data of 75 consecutive patients who had undergone clinical F-JK-PSMA-7 PET/CT imaging for tumor localization of biochemical recurrence (BCR). The pilot study in 10 patients who were examined with both PSMA tracers demonstrated that F-JK-PSMA-7 was at least equivalent to Ga-PSMA-11. All unequivocally Ga-PSMA-11-positive lesions could be also detected using F-JK-PSMA-7, and in 4 patients additional suspected PSMA-positive lesions were identified (1 patient changed from PSMA-negative to PSMA-positive). In patients with BCR (after prostatectomy or radiotherapy), the capacity of F-JK-PSMA-7 PET/CT to detect at least one PSMA-positive lesion was 84.8%. The prostate-specific antigen (PSA)-stratified detection rate of F-JK-PSMA-7 after prostatectomy varied among 54.5% (6/11 patients; PSA < 0.5 μg/L), 87.5% (14/16 patients; PSA 0.5-2 μg/L), and 90.9% (20/22 patients; PSA > 2 μg/L). The tracer F-JK-PSMA-7 was found to be safe and clinically useful. We demonstrated that F-JK-PSMA-7 was not inferior when directly compared with Ga-PSMA-11 in a pilot study but indeed identified additional PSMA-avid suspected lesions in oligometastasized patients with BCR. In a subsequent analysis of a clinical cohort of BCR patients, F-JK-PSMA-7 was useful in tumor localization. F-JK-PSMA-7 is recommended for future prospective trials.