PET/MRI Study of Men With Highly Suspicious MRI Lesions That Showed no Clinically Significant Prostate Cancer Following MRI Fusion Targeted Biopsy

December 3, 2020 updated by: NYU Langone Health
The principal aim of this study is to determine if PET/MRI imaging with 18-F fluciclovine (Axumin) identifies those men with false negative MRI fusion targeted biopsy (MRFTB) of PI-RADS 4 and 5 lesions. PI-RADS 4 and 5 MRI lesions are highly suspicious for clinically significant prostate cancer and require future repeat MRI imaging and possible repeat prostate biopsy depending on the results of the repeat MRI. Men, who had negative MRFTB within past 12 months of PI- RADS 4 or 5 MRI lesion will be included in this diagnostic study. The repeat MRI is standard of care at NYU Langone Health. The investigation aspect of the study is to perform an Axumin scan the same day as the MRI. Those men with persistent highly suspicious lesions will under MRFTB. The biopsy results will be compared with intensity of Axumin uptake within the prostate. The urologist will have the discretion to biopsy Axumin avid lesions not detected by MRI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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
        • New York University Langone Medical Center

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

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • The participant has undergone MRFTB of an MRI lesion at the Department of Urology or at 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:

  • 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: prior negative MRFTB of PI-RADS 4 and 5 lesions
Diagnosed withing 12 months of initial diagnostic cancer biopsy
Diagnostic test: Fluciclovine PET/MRI
It is unknown how many negative MRFTBs of PI-RADS 4 lesions are false negative biopsies or false positive tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with negative prostate biopsy
Time Frame: 12 Months
This will be measured by determining is if PET imaging with 18-F fluciclovine (Axumin) identifies those men with prior negative MRFTBs of PI-RADS 4 and 5 lesions who harbor clinically significant prostate cancer
12 Months

Collaborators and Investigators

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

Sponsor

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)

January 2, 2019

Primary Completion (Actual)

October 9, 2020

Study Completion (Actual)

October 9, 2020

Study Registration Dates

First Submitted

August 15, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (Actual)

August 17, 2018

Study Record Updates

Last Update Posted (Actual)

December 7, 2020

Last Update Submitted That Met QC Criteria

December 3, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-00601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The objective of the study is: to determine if PET imaging with 18-F fluciclovine identifies those men with prior negative MRFTBs of PI-RADS 4&5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Prostate Cancer

Clinical Trials on Fluciclovine PET/MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe