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Clinical Trial · NCT04986280
Diagnostic Accuracy and Performance of 18F-PSMA-1007
Overview
Whereas 18F-PSMA-1007 has rapidly established itself as a radiotracer for the investigation of prostate cancer, there are no studies confirming its diagnostic performance. The purpose of this study is to determine the diagnostic performance for this radiotracer.
Sponsor
Insel Gruppe AG, University Hospital Bern
Contacts
Ali Afshar-Oromieh, MD (STUDY_CHAIR)
ClinicalTrials.gov
NCT04986280Drug / Compound
PSMA-1007
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- PSMA
Ligand Class: Small Molecules
Eligibility
Inclusion
- Patients with known biochemical recurrence of a histologically confirmed primary prostate cancer, defined as:Post prostatectomy: two consecutive PSA \> 0.2 ng/ml Post-radiotherapy: a rise of 2ng/mL \> post-therapy nadir (ASTRO consensus definition)
- Adult Patients referred for investigation of recurrent PC by PSMA PET/CT.
- PSA measured ± 4 weeks of the PSMA-PET/CT
Exclusion
- Inability to provide informed, written consent
- Patients with ADT within 6 months prior to the PSMA-PET/CT
- Patients undergoing active treatment for a second non-prostatic malignancy
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