TY  - JOUR
AU  - Dietlein, Felix
AU  - Hohberg, Melanie
AU  - Kobe, Carsten
AU  - Zlatopolskiy, Boris D.
AU  - Krapf, Philipp
AU  - Endepols, Heike
AU  - Täger, Philipp
AU  - Hammes, Jochen
AU  - Heidenreich, Axel
AU  - Neumaier, Bernd
AU  - Drzezga, Alexander
AU  - Dietlein, Markus
TI  - An 18 F-Labeled PSMA Ligand for PET/CT of Prostate Cancer: First-in-Humans Observational Study and Clinical Experience with 18 F-JK-PSMA-7 During the First Year of Application
JO  - Journal of nuclear medicine
VL  - 61
IS  - 2
SN  - 2159-662X
CY  - New York, NY
PB  - Soc.
M1  - FZJ-2020-01701
SP  - 202 - 209
PY  - 2020
AB  - In preclinical trials, the recently developed tracer 2-methoxy-18F-DCFPyL (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 68Ga-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 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 18F-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 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-JK-PSMA-7 is recommended for future prospective trials. 
LB  - PUB:(DE-HGF)16
C6  - pmid:31324713
UR  - <Go to ISI:>//WOS:000512119600013
DO  - DOI:10.2967/jnumed.119.229542
UR  - https://juser.fz-juelich.de/record/874917
ER  -