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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Malignant Neoplasm of Prostate

Intervention / Treatment
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* Device: [F-18] NaF PET/CT
* Device: [F-18] fluciclovine PET/CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NaF PET/CT scan and F-18 fluciclovine PET/CT<br>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 | Device: [F-18] NaF PET/CT<br>* Radiotracer F-18 NaF used on the PET/CT imaging<br>Device: [F-18] fluciclovine PET/CT<br>* F-18 fluciclovine (Axumin ®) used on the PET/CT camera<br>* Other names: Axumin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of lesions seen by [F-18] NaF PET/CT which are also seen by [F-18] fluciclovine PET/CT | 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 | At time of scan, up to 60 minutes per scan | 
| Sensitivity | 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) | At time of scan, up to 60 minutes per scan | 
| Specificity | 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) | At time of scan, up to 60 minutes per scan | 
| Positive Predictive Value (PPV) | 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) | At time of scan, up to 60 minutes per scan | 
| Negative Predictive Value (NPV) | 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) | At time of scan, up to 60 minutes per scan | 
| Area under the curve (AUC) | Accuracy of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT evaluated via AUC using Receiver Operating Characteristic (ROC) curves | At time of scan, up to 60 minutes per scan |