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Clinical Trial · NCT05653856
Cu-64-PSMA-I&T Positron Emission Tomography (PET) Imaging of Metastatic PSMA Positive Lesions in Men With Prostate Cancer
Overview
This is a prospective, open-label Phase 2 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with recurrent metastatic prostate cancer after radical prostatectomy or radiation therapy.
Drug / Compound
PSMA I&T
Isotope(s):
COPPER-64
Radioisotope: Cu-64
Theranostic Role: PET Imaging
T1/2 (Half-Life): 12.7 Hours
Decay Mode: POSITRON β+, BETA, Electron Capture, GAMMA
Energy: 0.65 MeV, Gamma 511 keV
Range: max 2.5mm, mean 0.7mm
Decay Daughters: Ni64 (Stable), Zn64 (Stable)
Status: FDA Approval: DETECTNET®
Target(s):
- PSMA
Ligand Class: Small Molecules
Chelator: DOTAGA
Eligibility
Inclusion
- Prior Radical Prostatectomy: PSA \> 0.2 ng/mL, or
- Patients with histologically proven prostate adenocarcinoma.
- Patients with at least one extraprostatic site of disease suspected based on prior imaging or diagnosed by biopsy.
- Prior Radiation Therapy: 2 ng/mL rise in PSA over post-treatment nadir
- Prior radical prostatectomy or radiation therapy with curative intent.
Exclusion
- Body weight greater than 350 lb (158 kg).
- Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway, unless subject has a rising PSA level.
- Creatinine clearance (ClCr) less than 30 mL/min.
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