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

Case Comprehensive Cancer Center (Case CCC)

Status: Withdrawn

Conditions: Malignant Neoplasm of Prostate

Treatments: Device: [F-18] NaF PET/CT; Device: [F-18] fluciclovine PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT04765423

CASE11820

Details and patient eligibility

About

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 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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

NaF PET/CT scan and F-18 fluciclovine PET/CT

Experimental group

Description:

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

Treatment:

Device: [F-18] fluciclovine PET/CT

Device: [F-18] NaF PET/CT