Validation of FACBC as an Early Indicator of Sub-clinical Metastatic Disease Among High-risk Prostate Cancer Patients With Presumed Localized Disease


Condition: Cancer

Intervention:

  • Drug: FACBC PET-CT Imaging

Purpose: This study is for patients who have a high risk of metastatic prostate cancer (cancer that has spread outside of the prostate) who are going to have radical prostatectomy. The Anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC or Fluciclovine) positron emission tomography (PET) scan is a new imaging approach that has promising results in showing progression of cancer. The goal of this study is to determine if FACBC PET imaging will detect metastatic disease in patients with high risk prostate cancer who have negative conventional cross-sectional imaging such as computed tomography (CT) and/or magnetic resonance imaging (MRI), as well as bone scan and/or sodium fluoride PET. FACBC PET imaging may help detect metastatic prostate cancer in patients with newly diagnosed high risk primary prostate cancer and potentially improve staging of the cancer. Additionally, the researchers will compare the FACBC uptake in the prostate with uptake of FACBC detected in metastasis. They will also analyze and compare the prostate tissue, serum and urine parameters that are linked to higher rates of FACBC positivity.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03081884

Sponsor: Emory University

Primary Outcome Measures:

  • Measure: Positivity rate of FACBC PET
  • Time Frame: Day 1
  • Safety Issue:
  • Measure: Correlation between FACBC PET findings and results of other tests
  • Time Frame: Day 1, Day of surgery
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Correlation between FACBC uptake in the prostate with presence of FACBC-detected metastasis
  • Time Frame: Day 1
  • Safety Issue:

Estimated Enrollment: 88

Study Start Date: March 1, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • High-risk prostate cancer patients eligible for standard of care surgery
  • At least clinical T3a disease, and/or Gleason≥8, and/or Prostate-Specific Antigen (PSA) >20, as per clinical assessment and routine guidelines
  • Undergone standard of care conventional imaging (CT and/or MRI; bone scan and/or sodium fluoride (NaF) PET)

Exclusion Criteria:

  • Definitive findings of systemic metastasis on conventional imaging.

Contact:

  • Mehrdad Alemozaffar
  • 404-778-5864

Location:

  • Emory University Hospital
  • Atlanta Georgia 30322 United States

View trial on ClinicalTrials.gov


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