Axumin PETMRI Imaging Following Focal Cryo-ablation (FCA)

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04009083

Enrollment

Registered

2019-07-05

Start date

2019-06-19

Completion date

2021-01-07

Last updated

2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

18F-Fluciclovine PET imaging, Focal Cryo Ablation

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 .

Interventions

DEVICEStandard of Care MRI

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

OTHERFluciclovine 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 100 Years

Healthy 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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026