TheranosticTrials.org

Clinical Trial · NCT05034562

Gallium-68 PSMA-11 PET in Participants With Prostate Cancer

Overview

This phase II trial studies how well gallium-68 PSMA-11 PET/CT or PET/MRI works in finding prostate cancer cells that have come back (recurrent) in patients with prostate cancer. Gallium-68 PSMA-11 is a type of radioactive compound, called a radiotracer, which is injected in the vein and can accumulate in tumor cells to generate a signal detected by PET/CT or PET/MRI imaging. This may help researchers in finding recurrent prostate cancer cells in patients with prostate cancer.

Sponsor

MD Anderson Cancer Center

Phase

Phase 2

Contacts

Gregory C Ravizzini, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05034562

Drug / Compound

PSMA-11

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

Eligibility

Inclusion

  • Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)
  • Pathologically proven prostate cancer
  • Participants with known metastatic prostate cancer planned to undergo active systemic treatment
  • Karnofsky performance status (KPS) \>= 50 (Eastern Cooperative Oncology Group \[ECOG\]/World Health Organization \[WHO\] 0, 1, or 2)

Exclusion

  • Unable to lie flat, still, or tolerate a PET or MRI scan
  • Contraindication to optional furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. This exclusion criteria can be removed if furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction - (defined as either Ga-68 specific prompt gamma correction or multiple scatter model) is available for the used PET device