18-F Fluciclovine PET / MRI in Diagnosing Prostate Cancer in Patients with Suspicious Lesions

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Contact: Herbert Lepor
Phone: 646-825-6300

Trial Objectives and Outline

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 Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
Laura and Isaac Perlmutter Cancer Center at NYU Langone

Principal Investigator
Herbert Lepor

Trial IDs

Primary ID s18-00601
Secondary IDs NCI-2019-00344
Clinicaltrials.gov ID NCT03635866