Clinical Utility of 18F-Fluciclovine PET / MRI Imaging following Focal Cryo-Ablation of Prostate Cancer

Status: Active

Description

This trial studies 18F-fluciclovine positron emission tomography (PET) / magnetic resonance imaging (MRI) in identifying the recurrence of prostate cancer in men who have undergone focal cryoablation. PET imaging uses a radioactive drug (tracer) to make images of tissues in the body and how they are functioning. The PET tracer used in this study, 18F-fluciclovine, binds or sticks more to prostate cancer cells than surrounding normal tissues, which can be seen on the images. MRI uses radio waves and a magnet to make pictures of areas inside the body. The purpose of this study is to see if PET imaging with 18F-fluciclovine helps to identify recurrence of prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • FCA at New York University (NYU) Langone Health performed at least two years prior to study enrollment by Drs. Lepor or Wysock.
  • No prostate cancer specific treatment following FCA.
  • Consented to undergo reflex MRI and prostate biopsy two years following FCA.

Exclusion Criteria

  • Any contraindication to prostate biopsy.
  • Prior allergic reaction to 18F-fluciclovine.
  • Patient refuses MRI and prostate biopsy two years following FCA.

Locations & Contacts

New York

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

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To evaluate if PET imaging with fluciclovine F18 (18F-fluciclovine) (Axumin) improves sensitivity for detecting significant in field prostate cancer following focal cryoablation (FCA).

SECONDARY OBJECTIVES:

I. To determine if PET imaging with 18F-fluciclovine (Axumin) improves sensitivity and negative predictive value for detecting significant out of field disease recurrence following FCA.

OUTLINE:

Patients receive fluciclovine F18 intravenously (IV) and undergo PET imaging over 20-30 minutes and MRI over 40 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 s19-00123
Secondary IDs NCI-2019-04329
Clinicaltrials.gov ID NCT04009083