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Clinical Trial · NCT05707182
18F-rhPSMA-7.3 PET/MRI in Prostate Cancer Active Surveillance: a Pilot Study
Overview
The purpose of this study is to investigate the usefulness of PET/MRI with an investigational radioactive drug, 18F-rhPSMA-7.3, and MRI contrast in evaluating patients with prostate cancer eligible for active surveillance. This study is for imaging purposes only and is not a treatment study.
Drug / 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
- Men with biopsy-confirmed low risk or favorable intermediate risk prostate cancer who are scheduled to undergo multiparametric prostate MRI and confirmatory biopsy as per institutional active surveillance protocol.
Exclusion
- Biopsy-proven prostate cancer not eligible for active surveillance per institutional criteria.
- Current or prior treatment for prostate cancer.
- Inability to undergo 3 Tesla prostate MRI due to claustrophobia and/or MRI- incompatible devices or MR incompatible metal implants.
- Suspected prostate cancer without histologic confirmation.
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