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

Not Applicable

Withdrawn

• Conditions: Malignant Neoplasm of Prostate
• Interventions: Device: [F-18] NaF PET/CT; Device: [F-18] fluciclovine PET/CT

• Registration Number: NCT04765423
• Lead Sponsor: Case Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2021-02-18
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Study Start: 2021-03-25
• Status Verified: 2022-03
• Primary Completion: 2022-03-18
• Study Completion: 2022-03-18
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NaF PET/CT scan and F-18 fluciclovine PET/CT	[F-18] NaF 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
NaF PET/CT scan and F-18 fluciclovine PET/CT	[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

Primary Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States