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

Status: Active


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

Trial Objectives and Outline


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).


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.


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


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 ID NCT04009083