Axumin PETMRI Imaging Following Focal Cryo-ablation (FCA)
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About
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.
Full 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 .
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
31 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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