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Clinical Trial · NCT04733768
18F-PSMA-1007 PET/CT Imaging in Patients with Biochemically Recurrent or High-risk Prostate Cancer
Overview
Single centre prospective cohort phase II study of 18F-PSMA-1007 PET/CT imaging in patients with biochemically recurrent or high-risk prostate cancer. Safety, biodistribution, clinical efficacy, and diagnostic accuracy will be assessed. For diagnostic accuracy comparison will be made to a contemporary (within 10 days) conventional imaging study (bone scan and CT scan).
Drug / 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
Inclusion criteria not yet provided.
Exclusion
- Unable to lie flat for 30 minutes to complete the PET-CT imaging session
- History of allergic reaction to 18F-PSMA-1007 or 99mTc-MDP
- Both CT scan of the chest, abdomen, and pelvis and 99mTc-MDP bone scan within 3 months
- Unable to obtain consent
- Weight \>225 kg (weight limitation of PET/CT scanner)
- Lack of intravenous access
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