Optimizing Timing of rhPSMA-7.3 (18F) for Assessing Site(s) of Recurrent Disease Following Radical Prostatectomy

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

January 31, 2023

Primary Completion Date

May 31, 2025

Study Completion Date

November 30, 2025

Conditions
Prostate Cancer
Interventions
DRUG

18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent

Under development for the diagnosis of prostate cancer by Blue Earth Diagnostics. rhPSMA-7.3 (18F) will be administered intravenously as a single-dose injection. The molecular structure of the drug substance comprises a prostate-specific membrane antigen (PSMA) binding motif, a peptide spacer, an 18F-radiolabeled silicon fluoride acceptor moiety and a gallium chelator complex.

DEVICE

PET MRI Imaging

rhPSMA-7.3 (18F) PET MRI imaging will be conducted once at baseline and a second time within one year of the initial scan.

Trial Locations (1)

10016

Smilow Comprehensive Prostate Cancer Center, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Blue Earth Diagnostics

INDUSTRY

lead

NYU Langone Health

OTHER