Axumin PETMRI Imaging Following Focal Cryo-ablation (FCA)

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04009083
• Other study ID #: 19-00123
• Status: Completed
• Phase: N/A
• Start date: June 19, 2019
• Est. completion date: January 7, 2021

Study information

• Verified date: March 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 7, 2021
• Est. primary completion date: January 7, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Standard of Care MRI
Prostate MRI, serum Prostate Specific Antigen (PSA), in field and random systemic prostate biopsies

Other:
• 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

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of sensitivity following PET imaging with 18-F fluciclovine (Axumin)		1 Day