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J Nucl Med. 2019 Jul 19. pii: jnumed.119.229542. doi: 10.2967/jnumed.119.229542. [Epub ahead of print]

A novel 18F-labeled PSMA ligand for PET/CT imaging of prostate cancer patients: First-in-man observational study and clinical experience with 18F-JK-PSMA-7 during the first year of application.

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Department of Nuclear Medicine, University Hospital of Cologne, Germany.
Institute of Radiochemistry and Experimental Molecular Imaging, University Hospital of Cologne, Germany.
Institute of Neuroscience and Medicine, INM-5: Nuclear Chemistry, Forschungszentrum Jülich GmbH, Germany.
Department of Urology, University Hospital of Cologne, Germany.


In preclinical trials, the recently developed tracer 18F-JK-PSMA-7 (2-MeO-18F-DCFPyL) has been demonstrated to show 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, initial clinical utility of PET/CT imaging with 18F-JK-PSMA-7 was directly compared to 68Ga-PSMA-11 PET/CT in a group of 10 patients with prostate cancer. The two PSMA-tracers were administered in each patient less than 3 weeks 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. Using 18F-JK-PSMA-7, all unequivocally 68Ga-PSMA-11 positive lesions could be also detected by PET/CT and in 4 patients additional suspicious PSMA-positive lesions were identified (one patient changed from PSMA-negative to PSMA-positive). In patients with BCR (after prostatectomy or radiotherapy), the capacity of 18F-JK-PSMA-7 PET/CT to detect any PSMA-positive lesions was 84.8%. The PSA-stratified detection rate of 18F-JK-PSMA-7 after prostatectomy varied between 54.5% (6/11 patients; PSA < 0.5µg/l), 87.5% (14/16 patients; PSA 0.5-2 µg/l) and 90.9% (20/22 patients; PSA > 2µg/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 suspicious lesions in oligo-metastasized patients with BCR. In a subsequent analysis of a clinical cohort of BCR patients, 18F-JK-PSMA-7 was useful in tumor localization. 18F-JK-PSMA-7 is recommended for future prospective trials.


18F-JK-PSMA-7; Oncology: GU; PET imaging; PET/CT; PSMA tracer; Radiopharmaceuticals; prostate cancer


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