TheranosticTrials.org

Clinical Trial · NCT02830880

FACBC Prostate Therapy Response

Overview

The purpose of this study is to assess if using anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (FACBC or fluciclovine) PET scan will be useful in determining if participants are responding to chemotherapy treatment. Investigators will enroll participants whose cancer has been treated with hormone therapy and now the cancer is not responding to the treatment (castration -resistant), and so therefore will be started on chemotherapy. Investigators aim to enroll thirty participants in this study.

Sponsor

Emory University

Phase

Phase 2

Contacts

David Schuster, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02830880

Drug / Compound

FACBC

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

methylene diphosphonate

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

Eligibility

Inclusion

  • Primary or recurrent castration resistant prostate carcinoma with skeletal and/or nodal involvement not currently undergoing systemic chemotherapy who are about to commence therapy with docetaxel/prednisone. (Note that systemic hormonal targeted therapy including luteinizing hormone-releasing hormone (LHRH) agonists (Lupron or Trelstar), other anti-androgens, and/or Abiraterone or Enzalutamide may be in use.)
  • Ability to lie still for PET scanning

Exclusion

  • Currently undergoing chemotherapy for organ confined or systemic disease. This does not preclude patients who had previously received upfront docetaxel in the hormone sensitive setting.
  • Inability to lie still for PET scanning