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

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT03635866

Collaborator

(none)

Enrollment

Location

Arm

21.2

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Diagnostic Test: Fluciclovine PET/MRI	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 2, 2019

Actual Primary Completion Date :

Oct 9, 2020

Actual Study Completion Date :

Oct 9, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number of patients with negative prostate biopsy [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University Langone Medical Center	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Herbert Lepor, MD, NYU Langone Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT03635866

Other Study ID Numbers:

18-00601

First Posted:

Aug 17, 2018

Last Update Posted:

Dec 7, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Dec 7, 2020