Axumin PETMRI Imaging Following Focal Cryo-ablation (FCA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-19

Study Completion Date

2021-01-07

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.

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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 .

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Standard of Care

Group Type OTHER

Standard of Care MRI

Intervention Type DEVICE

Prostate MRI, serum Prostate Specific Antigen (PSA), in field and random systemic prostate biopsies

18F-Fluciclovine PET Scan

Group Type EXPERIMENTAL

Fluciclovine PET scan added to MRI

Intervention Type OTHER

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

Interventions

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Standard of Care MRI

Prostate MRI, serum Prostate Specific Antigen (PSA), in field and random systemic prostate biopsies

Intervention Type DEVICE

Fluciclovine PET scan added to MRI

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

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No