Axumin PETMRI Imaging Following Focal Cryo-ablation (FCA)

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT04009083
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.7
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Device: Standard of Care MRI; Other: Fluciclovine PET scan added to MRI	N/A

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 .

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: CLINICAL UTILITY OF AXUMIN PET/MRI IMAGING TWO YEARS FOLLOWING FOCAL CRYO-ABLATION (FCA) OF PROSTATE CANCER
• Actual Study Start Date: Jun 19, 2019
• Actual Primary Completion Date: Jan 7, 2021
• Actual Study Completion Date: Jan 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Standard of Care	Device: Standard of Care MRI; Prostate MRI, serum Prostate Specific Antigen (PSA), in field and random systemic prostate biopsies
Experimental: 18F-Fluciclovine PET Scan	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

Outcome Measures

Primary Outcome Measures

1. Measure of sensitivity following PET imaging with 18-F fluciclovine (Axumin) [1 Day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Herbert Lepor, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT04009083
• Other Study ID Numbers: 19-00123
• First Posted: Jul 5, 2019
• Last Update Posted: Mar 30, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by NYU Langone Health: 18F-Fluciclovine PET imaging; Focal Cryo Ablation
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Mar 30, 2021