Malignant Neoplasm of Prostate
Conditions
Brief summary
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
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
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of lesions seen by [F-18] NaF PET/CT which are also seen by [F-18] fluciclovine PET/CT | 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) 1. Definitely benign 2. Probably benign 3. Equivocal 4. Probably malignant 5. Definitely malignant |
| Sensitivity | 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 | 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) | 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) | 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) | 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 |
Countries
United States
Outcome results
None listed