TheranosticTrials.org

Clinical Trial · NCT03762759

Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes

Overview

This phase II trial studies how well a positron emission tomography (PET)/computed tomography (CT) scan using fluciclovine F18 compared with a PET/CT scan with 68Ga-PSMA works in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma. Fluciclovine F18 and 68Ga-PSMA are types of tracers, called radiotracers, that are injected and can accumulate in tumor cells to develop images of them during a PET/CT scan. It is not yet known whether giving fluciclovine F18 or 68Ga-PSMA may work better in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma.

Sponsor

Emory University

Phase

Phase 2

Contacts

Ashesh Jani, MD, MSEE (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03762759

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

Eligibility

Inclusion

  • Detectable prostate-specific antigen (PSA)
  • Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2
  • Willingness to undergo pelvic radiotherapy
  • No definitive findings of systemic (extrapelvic) metastasis on CT and/or magnetic resonance (MR) scan of abdomen and pelvis
  • Adenocarcinoma of the prostate, post radical-prostatectomy
  • No definitive findings for skeletal metastasis on technetium 99-m methyl diphosphonate (MDP) or F-18 PET bone scan

Exclusion

  • Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients
  • Inability to undergo fluciclovine or Ga-PSMA PET-CT
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Definitive findings of systemic metastasis on conventional imaging or biopsy
  • Severe acute co-morbidity, defined as follows:
  • Transmural myocardial infarction within the last 6 months
  • Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic radiotherapy)
  • Unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration