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Clinical Trial · NCT07220720
POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2/3 Lesions
Overview
The goal of this study to determine if using the (18)F-rhPSMA-7.3 PET-CT scan can improve the ability to spot serious prostate cancer in patients who have uncertain MRI results. These uncertain results include MRI results that showed a PIRADS 2 or PIRADS 3 area on the prostate. The investigators want to find out if this new test is better to detect prostate cancer than just doing a biopsy based on MRI alone.
Sponsor
University of Colorado, Denver
Phase
Phase 2
Contacts
Shelby Sparks (CONTACT)
urologyresearch@jax.ufl.edu
904-244-7340
ClinicalTrials.gov
NCT07220720Drug / Compound
rhPSMA-7.3
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
- The patient has PIRADS 2 and/or PIRADS 3 lesions detected by a board-certified radiologist.
- The patient is a candidate for a targeted MRI/US biopsy and is scheduled to undergo the procedure. Only patients scheduled for a biopsy before recruitment will be considered candidates.
Exclusion
Exclusion criteria not yet provided.
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