Universität zu Köln

Dietlein, Felix, Hohberg, Melanie, Kobe, Carsten, Zlatopolskiy, Boris D., Krapf, Philipp, Endepols, Heike ORCID: 0000-0002-6166-4818, Taeger, Philipp, Hammes, Jochen, Heidenreich, Axel, Neumaier, Bernd, Drzezga, Alexander and Dietlein, Markus (2020). An F-18-Labeled PSMA Ligand for PET/CT of Prostate Cancer: First-in-Humans Observational Study and Clinical Experience with F-18-JK-PSMA-7 During the First Year of Application. J. Nucl. Med., 61 (2). S. 202 - 210. RESTON: SOC NUCLEAR MEDICINE INC. ISSN 1535-5667

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Abstract

In preclinical trials, the recently developed tracer 2-methoxy-F-18-DCFPyL (F-18-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-18-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 F-18-JK-PSMA-7 was directly compared with Ga-68-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-18-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 F-18-JK-PSMA-7 was at least equivalent to Ga-68-PSMA-11. All unequivocally Ga-68-PSMA-11-positive lesions could be also detected using F-18-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-18-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-18-JK-PSMA-7 after prostatectomy varied among 54.5% (6/11 patients; PSA, 0.5 mu g/L), 87.5% (14/16 patients; PSA 0.52 mu g/L), and 90.9% (20/22 patients; PSA. 2 mu g/L). Conclusion: The tracer F-18-JK-PSMA-7 was found to be safe and clinically useful. We demonstrated that F-18-JK-PSMA-7 was not inferior when directly compared with Ga-68-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-18-JK-PSMA-7 was useful in tumor localization. F-18-JK-PSMA-7 is recommended for future prospective trials.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Dietlein, Felix UNSPECIFIED UNSPECIFIED UNSPECIFIED Hohberg, Melanie UNSPECIFIED UNSPECIFIED UNSPECIFIED Kobe, Carsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Zlatopolskiy, Boris D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Krapf, Philipp UNSPECIFIED UNSPECIFIED UNSPECIFIED Endepols, Heike UNSPECIFIED orcid.org/0000-0002-6166-4818 UNSPECIFIED Taeger, Philipp UNSPECIFIED UNSPECIFIED UNSPECIFIED Hammes, Jochen UNSPECIFIED UNSPECIFIED UNSPECIFIED Heidenreich, Axel UNSPECIFIED UNSPECIFIED UNSPECIFIED Neumaier, Bernd UNSPECIFIED UNSPECIFIED UNSPECIFIED Drzezga, Alexander UNSPECIFIED UNSPECIFIED UNSPECIFIED Dietlein, Markus UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-347502
DOI:	10.2967/jnumed.119.229542
Journal or Publication Title:	J. Nucl. Med.
Volume:	61
Number:	2
Page Range:	S. 202 - 210
Date:	2020
Publisher:	SOC NUCLEAR MEDICINE INC
Place of Publication:	RESTON
ISSN:	1535-5667
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language MEMBRANE ANTIGEN PSMA; BIOCHEMICAL RECURRENCE; T PET/CT; HBED-CC; DIAGNOSIS; LESIONS Multiple languages Radiology, Nuclear Medicine & Medical Imaging Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/34750