NCT04009083

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

1.6 years

First QC Date

July 2, 2019

Last Update Submit

March 29, 2021

Conditions

Prostate Cancer

Keywords

18F-Fluciclovine PET imagingFocal Cryo Ablation

Outcome Measures

Primary Outcomes (1)

  • Measure of sensitivity following PET imaging with 18-F fluciclovine (Axumin)

    1 Day

Study Arms (2)

Standard of Care

OTHER
Device: Standard of Care MRI

18F-Fluciclovine PET Scan

EXPERIMENTAL
Other: Fluciclovine PET scan added to MRI

Interventions

Standard of Care MRIDEVICE

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

Standard of Care
Fluciclovine PET scan added to MRIOTHER

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

18F-Fluciclovine PET Scan

Eligibility Criteria

Age18 Years - 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Any contraindication to prostate biopsy
  • Prior allergic reaction to 18F-Fluciclovine
  • Patient refuses MRI and prostate biopsy two years following FCA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Herbert Lepor, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 5, 2019

Study Start

June 19, 2019

Primary Completion

January 7, 2021

Study Completion

January 7, 2021

Last Updated

March 30, 2021

Record last verified: 2021-03

Locations

US(1)