Axumin PETMRI Imaging Following Focal Cryo-ablation (FCA)

March 29, 2021 updated by: NYU Langone Health

CLINICAL UTILITY OF AXUMIN PET/MRI IMAGING TWO YEARS FOLLOWING FOCAL CRYO-ABLATION (FCA) OF PROSTATE CANCER

This is a prospective outcomes study assessing quality of life and oncological control at pre-defined time points following FOCAL CRYO-ABLATION (FCA). The investigator's standard of care is to perform an Magentic Resonance Imaging (MRI) and prostate biopsy two years following FCA. The prostate biopsy assesses both the presence of in field and out of field disease. The role of Axumin PET/MRI for detecting disease following FCA has not been previously examined.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary hypothesis of this study is that 18F-Fluciclovine PET/MRI imaging at two years following FCA will improve sensitivity for detection of in field recurrence of significant prostate cancer defined as any Gleason pattern 4 disease.

The secondary hypothesis of this study is that 18F-Fluciclovine PET/MRI imaging at two years following FCA will improve sensitivity for detection of out of field recurrence of significant prostate cancer .

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • FCA at 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Standard of Care
Device: Standard of Care MRI
Prostate MRI, serum Prostate Specific Antigen (PSA), in field and random systemic prostate biopsies
EXPERIMENTAL: 18F-Fluciclovine PET Scan
Other: Fluciclovine PET scan added to MRI
18F-Fluciclovine (Axumin) is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure of sensitivity following PET imaging with 18-F fluciclovine (Axumin)
Time Frame: 1 Day
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Herbert Lepor, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 19, 2019

Primary Completion (ACTUAL)

January 7, 2021

Study Completion (ACTUAL)

January 7, 2021

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 3, 2019

First Posted (ACTUAL)

July 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-00123

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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