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Axumin PETMRI Imaging Following Focal Cryo-ablation (FCA)

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ClinicalTrials.gov Identifier: NCT04009083
Recruitment Status : Recruiting
First Posted : July 4, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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 Not Applicable

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 .


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 : June 19, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Measure of sensitivity following PET imaging with 18-F fluciclovine (Axumin) [ Time Frame: 1 Day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04009083


Contacts
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Contact: Rozalba Gogaj (646)-825-6356 Rozalba.Gogaj@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Rozalba Gogaj    646-825-6356    Rozalba.Gogaj@nyulangone.org   
Principal Investigator: Herbert Lepor, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Herbert Lepor, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04009083     History of Changes
Other Study ID Numbers: 19-00123
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019

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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:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases