Axumin PETMRI Imaging Following Focal Cryo-ablation (FCA)

Study Overview
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Brief Summary
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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
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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 .

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Standard of Care MRI
* Other: Fluciclovine PET scan added to MRI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard of Care<br> | Device: Standard of Care MRI<br>* Prostate MRI, serum Prostate Specific Antigen (PSA), in field and random systemic prostate biopsies<br>|
| Experimental: 18F-Fluciclovine PET Scan<br> | Other: Fluciclovine PET scan added to MRI<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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18F-Fluciclovine PET imaging, Focal Cryo Ablation