Fluciclovine (18F) PET / CT Imaging in Indicating Early Metastatic Disease in Patients with High or Unfavorable Intermediate-Risk Prostate Cancer

Status: Active

Description

This clinical trial studies how well fluciclovine (18F) positron emission tomography (PET) / computed tomography (CT) imaging works in indicating early metastatic disease in patients with high or unfavorable intermediate-risk prostate cancer. Radioactive tracers, such as 18F may enter prostate tumor cells. PET / CT imaging performed with 18F may be a better way to determine if cancer has spread outside of the prostate.

Eligibility Criteria

Inclusion Criteria

  • High-risk or very-high risk prostate cancer eligible for standard of care surgery * At least clinical T3a disease, and/or Gleason >= 8, and/or PSA > 20, as per clinical assessment and routine guidelines
  • Unfavorable risk intermediate prostate cancer eligible for standard of care surgery * Grade group 2 (Gleason score 3+4) with either PSA 10 - < 20 or clinical stage T2b-c, OR grade group 3 (Gleason 4+3) with PSA < 20
  • Undergone standard of care conventional imaging (computed tomography [CT] and/or magnetic resonance [MR]; bone scan and/or sodium fluoride [NaF] PET)

Exclusion Criteria

  • Definitive findings of systemic metastasis on conventional imaging

Locations & Contacts

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Contact: Mehrdad Alemozaffar
Phone: 404-778-5864

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To validate 18F (anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid [FACBC]) as an early indicator of occult metastatic disease among high-risk or unfavorable intermediate-risk prostate cancer patients with presumed localized disease.

SECONDARY OBJECTIVES:

I. To evaluate the correlation of FACBC uptake in the prostate with presence of FACBC-detected metastasis.

TERTIARY OBJECTIVES:

I. To evaluate tissue ribonucleic acid (RNA) signatures of prostate cancer, as well as urine RNA and serum phi parameters that are associated with higher rate of FACBC positivity in this cohort.

OUTLINE:

Patients receive fluciclovine intravenously (IV) and then undergo PET/CT scan.

After completion of study, patients are followed up periodically for 10 years.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Diagnostic

Lead Organization

Lead Organization
Emory University Hospital / Winship Cancer Institute

Principal Investigator
Mehrdad Alemozaffar

Trial IDs

Primary ID EU3330-16
Secondary IDs NCI-2017-00251, IRB00092595
Clinicaltrials.gov ID NCT03081884