Clinical Trial · NCT05002465

Clinical Use of 68Ga PSMA-11 PET/CT in Diagnosing, Staging and Restaging Prostate Cancer

Overview

The purpose of this protocol is to provide 68Ga Prostate Specific Membrane Antigen-11 (68Ga PSMA-11) for clinical use in the diagnosis, staging and restaging of prostate cancer using Positron Emission Tomography with Computed Tomography (PET/CT) prior to its full local Federal Drug Administration (FDA) approval. Extensive research has shown that 68Ga PSMA-11 PET/CT offers higher detection rate of metastatic disease in prostate cancer than the current standard of care usually used in staging and restaging prostate cancer.

Sponsor

University of Texas Southwestern Medical Center

Contacts

Orhan K Oz, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05002465

Drug / Compound

PSMA-11

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: HBED-CC

Eligibility

Inclusion

One of the following:
Patients with metastatic prostate cancer, for whom Lutetium-177 vipivotide tetraxetan PSMA-directed therapy is indicated.
Patients must be deemed medically stable by their treating physician.
Patients with suspected recurrence based on elevated serum prostate specific antigen (PSA) level.
Patients must be able to lie still for approximately 20 - 40 minutes for the PET/CT scans.
Patients with suspected metastasis who are candidates for initial definitive therapy.

Exclusion

Patients must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11.
Patients must not be claustrophobic.
Patients must not weigh more than the maximum weight limit for the PET/CT scanner table (\> 225 kilograms or 500 pounds).