Back to resultsPET/MRI Study of Men With Highly Suspicious MRI Lesions That Showed no Clinically Significant Prostate Cancer Following MRI Fusion Targeted Biopsy
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluciclovine PET/MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- New York University Langone Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
prior negative MRFTB of PI-RADS 4 and 5 lesions
Arm Description
Diagnosed withing 12 months of initial diagnostic cancer biopsy
Outcomes
Primary Outcome Measures
Number of patients with negative prostate biopsy
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03635866
Brief Title
PET/MRI Study of Men With Highly Suspicious MRI Lesions That Showed no Clinically Significant Prostate Cancer Following MRI Fusion Targeted Biopsy
Official Title
PET/MRI Study of Men With Highly Suspicious MRI Lesions That Showed no Clinically Significant Prostate Cancer Following MRI Fusion Targeted Biopsy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
October 9, 2020 (Actual)
Study Completion Date
October 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
prior negative MRFTB of PI-RADS 4 and 5 lesions
Arm Type
Experimental
Arm Description
Diagnosed withing 12 months of initial diagnostic cancer biopsy
Intervention Type
Diagnostic Test
Intervention Name(s)
Fluciclovine PET/MRI
Intervention Description
It is unknown how many negative MRFTBs of PI-RADS 4 lesions are false negative biopsies or false positive tests.
Primary Outcome Measure Information:
Title
Number of patients with negative prostate biopsy
Description
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
Time Frame
12 Months
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert Lepor, MD
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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
Learn more about this trial
PET/MRI Study of Men With Highly Suspicious MRI Lesions That Showed no Clinically Significant Prostate Cancer Following MRI Fusion Targeted Biopsy
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