This clinical trial studies how well fluciclovine (18F) positron emission tomography (PET)/computed tomography (CT) imaging works in indicating early metastatic disease in patients with high or unfavorable intermediate-risk prostate cancer. Radioactive tracers, such as 18F may enter prostate tumor cells. PET/CT imaging performed with 18F may be a better way to determine if cancer has spread outside of the prostate.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03081884.
PRIMARY OBJECTIVES:
I. To validate 18F (anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid [FACBC]) as an early indicator of occult metastatic disease among high-risk or unfavorable intermediate-risk prostate cancer patients with presumed localized disease.
SECONDARY OBJECTIVES:
I. To evaluate the correlation of FACBC uptake in the prostate with presence of FACBC-detected metastasis.
TERTIARY OBJECTIVES:
I. To evaluate tissue ribonucleic acid (RNA) signatures of prostate cancer, as well as urine RNA and serum phi parameters that are associated with higher rate of FACBC positivity in this cohort.
OUTLINE:
Patients receive fluciclovine intravenously (IV) and then undergo PET/CT scan.
After completion of study, patients are followed up periodically for 10 years.
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorMehrdad Alemozaffar
