MedTrace Logo

Axumin PETMRI Imaging Following Focal Cryo-ablation (FCA)

NCT04009083 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-03-30

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Herbert Lepor, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-19
Primary Completion
2021-01-07
Completion
2021-01-07

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04009083 on ClinicalTrials.gov