18-F Fluciclovine PET / MRI in Diagnosing Prostate Cancer in Patients with Suspicious Lesions
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.
- The participant has undergone MRFTB of an MRI lesion at the Department of Urology or at New York University (NYU) Langone Health within past 12 months and has signed informed consent to participate in the NYU Urology prostate biopsy database
- The most recent MRFTB of a PIRADS 4 or 5 lesion did not show clinically significant prostate cancer
- Any contraindication to MRI
- Patient has received greater than 5 rem radiation annually, including from other sources
- The urologist who performed the initial MRFTB, does not feel a repeat MRI is indicated
- Any contraindication to prostate biopsy including untreated urinary tract infection
- Prior allergic reaction to Axumin
- Patient refuses MRI
Locations & Contacts
Contact: Herbert Lepor
Trial Objectives and Outline
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.
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.
Patients receive 18-F fluciclovine intravenously (IV) and undergo PET/MRI over 20-30 minutes.
Trial Phase & Type
No phase specified
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Secondary IDs NCI-2019-00344
Clinicaltrials.gov ID NCT03635866