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Clinical Trial · NCT04134208
An Investigational Scan (18F-Fluciclovine PET-CT) for the Measurement of Therapeutic Response in Patients With Metastatic Prostate Cancer
Overview
This phase IV trial studies how well an investigational scan (18F-fluciclovine PET-CT) works for the measurement of therapeutic response in patients with prostate cancer that has spread to other places in the body (metastatic). 18F-fluciclovine is a radioactive substance that is used in this study with PET-CT imaging scans that may help doctors learn about response to standard therapy in patients with prostate cancer.
Sponsor
MD Anderson Cancer Center
Phase
Phase 4
Contacts
Gregory C Ravizzini (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT04134208Drug / Compound
Fluciclovine
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Amino Acid Transport
Ligand Class: Small Molecules
Eligibility
Inclusion
- Castration naive disease, no prior systemic therapy for prostate cancer
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Documented evidence of M1 disease by American Joint Committee on Cancer (AJCC) staging by bone scan, CT and magnetic resonance imaging (MRI)
- Histologically or cytologically proven prostate carcinoma
Exclusion
- Small cell carcinoma of the prostate
- Known brain metastasis
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