Axumin PETMRI Imaging Following Focal Cryo-ablation (FCA)

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Device: Standard of Care MRI; Other: Fluciclovine PET scan added to MRI

• Registration Number: NCT04009083
• Lead Sponsor: NYU Langone Health

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 .

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-06-19
• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-05
• Primary Completion: 2021-01-07
• Study Completion: 2021-01-07
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 31

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.

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Exclusion Criteria

• Any contraindication to prostate biopsy
• Prior allergic reaction to 18F-Fluciclovine
• Patient refuses MRI and prostate biopsy two years following FCA.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care MRI	-
18F-Fluciclovine PET Scan	Fluciclovine PET scan added to MRI	-

Primary Outcome Measures

Name	Time	Method
Measure of sensitivity following PET imaging with 18-F fluciclovine (Axumin)	1 Day

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States