Clinical Trial · NCT05527483

Digital PET/CT Using [Ga-68]PSMA vs. [F-18]NaF for Evaluation of Osseous Metastatic Involvement in Prostate Cancer Patients

Overview

The purpose of this study is to evaluate a radioactive diagnostic study drug, which is called Gallium-68 Prostate Specific Membrane Antigen (\[Ga-68\]PSMA) for detection of bone metastasis in patients with prostate cancer. For imaging the investigators will use a FDA approved imaging technology, digital Positron Emission Tomography (PET/CT). The investigators would like to know if digital PET/CT using \[Ga-68\]PSMA provides accurate information about the extent of bone metastases. Therefore, the investigators will compare\[Ga-68\]PSMA PET/CT with Flourine-18 \[F-18\] Sodium Fluoride (NaF), which is a high resolution bone scan. \[F-18\]NaF is FDA approved and the reference standard for evaluating the presence of bone metastases.\[Ga-68\]PSMA is an investigational (experimental) drug that works by binding to Prostate Specific Membrane Antigen, which is overexpressed in prostate cancer. \[Ga-68\]PSMA is experimental because it is not approved by the Food and Drug Administration (FDA) at University Hospitals. However, FDA approval has been obtained for this study protocol by an Investigational New Drug (IND) application.

Contacts

Robert Jones, M.D. (PRINCIPAL_INVESTIGATOR)

Norbert Avril, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05527483

Drug / Compound

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

Sodium Fluoride

Isotope(s):
Target(s):
  • Bone Metabolism
Ligand Class: Small Molecules

Eligibility

Inclusion

  • 2\) Patients have known or highly suspected osseous metastatic involvement defined by the referring physician based on clinical history and/or findings from standard of care imaging.
  • 5\) Informed written consent must be given and signed
  • 4\) Patients able to tolerate PET/CT scans
  • 1\) Patients must have a history of prostate cancer

Exclusion

  • 4\. Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
  • 5\. Patients with a known allergy against Ga-68 PSMA or F-18 NaF
  • 1\. Subjects who do not meet the noted inclusion criteria