Back to resultsAxumin PETMRI Imaging Following Focal Cryo-ablation (FCA)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care MRI
Fluciclovine PET scan added to MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring 18F-Fluciclovine PET imaging, Focal Cryo Ablation
Eligibility Criteria
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.
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Standard of Care
18F-Fluciclovine PET Scan
Arm Description
Outcomes
Primary Outcome Measures
Measure of sensitivity following PET imaging with 18-F fluciclovine (Axumin)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04009083
Brief Title
Axumin PETMRI Imaging Following Focal Cryo-ablation (FCA)
Official Title
CLINICAL UTILITY OF AXUMIN PET/MRI IMAGING TWO YEARS FOLLOWING FOCAL CRYO-ABLATION (FCA) OF PROSTATE CANCER
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 19, 2019 (Actual)
Primary Completion Date
January 7, 2021 (Actual)
Study Completion Date
January 7, 2021 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
18F-Fluciclovine PET imaging, Focal Cryo Ablation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
Other
Arm Title
18F-Fluciclovine PET Scan
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Standard of Care MRI
Intervention Description
Prostate MRI, serum Prostate Specific Antigen (PSA), in field and random systemic prostate biopsies
Intervention Type
Other
Intervention Name(s)
Fluciclovine PET scan added to MRI
Intervention Description
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
Primary Outcome Measure Information:
Title
Measure of sensitivity following PET imaging with 18-F fluciclovine (Axumin)
Time Frame
1 Day
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert Lepor, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Axumin PETMRI Imaging Following Focal Cryo-ablation (FCA)
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