Fluciclovine (Axumin) PET/CT vs. NaF PET/CT in Prostate Cancer Osseous Metastatic Disease

Overview

The purpose of this study is to look at whether F-18 Fluciclovine (i.e. Axumin) is better or as good as F-18 Sodium Fluoride (F-18 NaF) when looking at bone disease from prostate cancer. Axumin is a radioactive agent used on a positron/computed tomography (PET/CT) camera to look for prostate cancer in general.

Full Title of Study: “[F-18] Fluciclovine (Axumin) PET/CT vs. [F-18] NaF PET/CT in the Evaluation of Prostate Cancer Osseous Metastatic Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2022

Detailed Description

The study will assess the diagnostic performance of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT as the reference standard. Each bone lesion identified on [F-18] NaF PET/CT will be compared with the level of [F-18] fluciclovine uptake The primary objective is to assess [F-18] fluciclovine efficacy in the evaluation of osseous metastatic disease in prostate cancer on a lesion-by-lesion comparison with [F-18] NaF as a the reference standard.

Interventions

  • Device: [F-18] NaF PET/CT
    • Radiotracer F-18 NaF used on the PET/CT imaging
  • Device: [F-18] fluciclovine PET/CT
    • F-18 fluciclovine (Axumin ®) used on the PET/CT camera

Arms, Groups and Cohorts

  • Experimental: NaF PET/CT scan and F-18 fluciclovine PET/CT
    • Visit 1: Participant receives a whole body [F-18] NaF PET/CT (diagnostic study) Visit 2: Participant receives a whole body [F-18] fluciclovine PET/CT within 3 weeks of Visit 1

Clinical Trial Outcome Measures

Primary Measures

  • Number of lesions seen by [F-18] NaF PET/CT which are also seen by [F-18] fluciclovine PET/CT
    • Time Frame: At time of scan, up to 60 minutes per scan
    • Agreement of imaging methods as measured by number of lesions seen by [F-18] NaF PET/CT which are also seen by [F-18] fluciclovine PET/CT broken down by diagnostic score on a lesion-by-lesion basis (1 to 5) Definitely benign Probably benign Equivocal Probably malignant Definitely malignant
  • Sensitivity
    • Time Frame: At time of scan, up to 60 minutes per scan
    • Accuracy of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT evaluated via sensitivity Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN): Sensitivity = TP / (TP+FN)
  • Specificity
    • Time Frame: At time of scan, up to 60 minutes per scan
    • Accuracy of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT evaluated via specificity Specificity is the number of true Negatives (TN) divided by the sum of TN and false positives (FP): Sensitivity = TN / (TN+FP)
  • Positive Predictive Value (PPV)
    • Time Frame: At time of scan, up to 60 minutes per scan
    • Accuracy of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT evaluated via PPV PPV is the number of true TP divided by the sum of TP and FP: Sensitivity = TP / (TP+FP)
  • Negative Predictive Value (NPV)
    • Time Frame: At time of scan, up to 60 minutes per scan
    • Accuracy of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT evaluated via NPV NPV is the number of true TN divided by the sum of TN and FN: Sensitivity = TN / (TN+FN)
  • Area under the curve (AUC)
    • Time Frame: At time of scan, up to 60 minutes per scan
    • Accuracy of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT evaluated via AUC using Receiver Operating Characteristic (ROC) curves

Participating in This Clinical Trial

Inclusion Criteria

  • Referred for initial staging or restaging of prostate cancers with clinical suspicion of bone metastases. – Must understand and voluntarily sign an Informed Consent Document Exclusion Criteria:

-Cannot tolerate imaging up to 60 minutes of total imaging

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Case Comprehensive Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Robert Jones, MD, Principal Investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
  • Overall Contact(s)
    • Robert Jones, MD, 1-800-641-2422, CTUReferral@UHhospitals.org

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