This trial studies how well 18-F fluciclovine positron emission tomography (PET)/magnetic resonance imaging (MRI) works in diagnosing prostate cancer in patients with suspicious lesions. 18-F fluciclovine is taken up to a greater extent in prostate cancer cells than in surrounding normal tissues, and may be more accurate in diagnosing prostate cancer when given for PET/MRI.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03635866.
PRIMARY OBJECTIVES:
I. To determine if PET imaging with 18-F fluciclovine (Axumin) identifies those men with false negative MRI fusion targeted biopsies (MRFTBs) of Prostate Imaging Reporting and Data System (PI-RADS) 4 and 5 lesions.
SECONDARY OBJECTIVES:
I. To determine if the intensity of Axumin staining of PI-RADS 4 and 5 lesions found to harbor prostate cancer discriminates Gleason Grade Group.
OUTLINE:
Patients receive 18-F fluciclovine intravenously (IV) and undergo PET/MRI over 20-30 minutes.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationLaura and Isaac Perlmutter Cancer Center at NYU Langone
Principal InvestigatorHerbert Lepor
