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.
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 .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
31
Prostate MRI, serum Prostate Specific Antigen (PSA), in field and random systemic prostate biopsies
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
NYU Langone Health
New York, New York, United States
Measure of sensitivity following PET imaging with 18-F fluciclovine (Axumin)
Time frame: 1 Day
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