TheranosticTrials.org

Clinical Trial · NCT03515577

Gallium Ga 68-labeled PSMA-11 PET/CT and Fluciclovine F18 PET/CT in Imaging Participants With Recurrent Prostate Cancer After Surgery

Overview

This phase II trial compares how well gallium 68-labeled PSMA-11 positron emission tomography/computed tomography (PET/CT) works compared to fluciclovine F18 PET/CT in imaging participants with prostate cancer after surgery that has come back. PET is an established imaging technique that uses small amounts of radioactivity and CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the body. Diagnostic procedures, such as PET/CT with gallium 68-labeled PSMA-11, may work better than PET/CT with fluciclovine F18 in helping find out how far the prostate cancer has spread.

Sponsor

Jonsson Comprehensive Cancer Center (UCLA)

Phase

Phase 2

Contacts

Johannes Czernin, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03515577

Drug / Compound

Fluciclovine

Isotope(s):
Target(s):
  • Amino Acid Transport
Ligand Class: Small Molecules

PSMA-11

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

Eligibility

Inclusion

  • Axumin PET/CT scan already performed or scheduled as best standard of care procedure for suspected disease relapse within 2 weeks before or after intended 68Ga-PSMA-11 PET/CT
  • Histopathologically proven prostate cancer (PCa)
  • PSA values ranging from 0.2 ng/mL to 2 ng/mL
  • Radical prostatectomy as definitive treatment for PCa
  • Proven biochemical recurrence as defined by American Urological Association (AUA) recommendation: PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after radical prostatectomy
  • No prior salvage therapies (including salvage radiotherapy and/or salvage lymph node dissection)
  • Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization \[WHO\] equivalent)

Exclusion

  • Unable to lie flat, still or tolerate a PET scan
  • Any change in prostate cancer treatment between Axumin and 68Ga-PSMA PET/CT scan

Patient Education

Patient education not yet provided.

Publications

Publications not yet provided.

Locations

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