18F-PSMA
An 18F-Labeled PSMA Ligand for PET/CT of Prostate Cancer: First-in Humans Observational Study and Clinical Experience with 18F-JK-PSMA-7 During the First Year of Application
Felix Dietlein, Melanie Hohberg, Carsten Kobe, Boris D. Zlatopolskiy, Philipp Krapf, Heike Endepols, Philipp Täger, Jochen Hammes, Axel Heidenreich, Bernd Neumaier, Alexander Drzezga, and Markus Dietlein.
In preclinical trials, the recently developed tracer 2-methoxy-18FDCFPyL (18F-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 18F-JK-PSMA-7 for PET/CT imaging of patients with prostate cancer.
Methods
In an Institutional Review Board–approved pilot study, the initial clinical utility of PET/CT imaging with 18F-JK-PSMA-7 was directly compared with 68GaPSMA-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 18F-JK PSMA-7 PET/CT imaging for tumor localization of biochemical recurrence (BCR).
Results
The pilot study in 10 patients who were examined with both PSMA tracers demonstrated that 18F-JK-PSMA-7 was at least equivalent to 68Ga-PSMA-11. All unequivocally 68Ga-PSMA-11–positive lesions could be also detected using 18F-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 18FJK-PSMA-7 PET/CT to detect at least one PSMA-positive lesion was 84.8%. The prostate-specific antigen (PSA)–stratified detection rate of 18F-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).
Conclusion
The tracer 18F-JK-PSMA-7 was found to be safe and clinically useful. We demonstrated that 18F-JK-PSMA-7 was not inferior when directly compared with 68Ga-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, 18F-JK-PSMA-7 was useful in tumor localization. 18F-JKPSMA-7 is recommended for future prospective trials.
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