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Completed

NCT Number: NCT03635866

PET/MRI Study of Men With Highly Suspicious MRI Lesions That Showed no Clinically Significant Prostate Cancer Following MRI Fusion Targeted Biopsy

The principal aim of this study is to determine if PET/MRI imaging with 18-F fluciclovine (Axumin) identifies those men with false negative MRI fusion targeted biopsy (MRFTB) of PI-RADS 4 and 5 lesions. PI-RADS 4 and 5 MRI lesions are highly suspicious for clinically significant prostate cancer and require future repeat MRI imaging and possible repeat prostate biopsy depending on the results of the repeat MRI. Men, who had negative MRFTB within past 12 months of PI- RADS 4 or 5 MRI lesion will be included in this diagnostic study. The repeat MRI is standard of care at NYU Langone Health. The investigation aspect of the study is to perform an Axumin scan the same day as the MRI. Those men with persistent highly suspicious lesions will under MRFTB. The biopsy results will be compared with intensity of Axumin uptake within the prostate. The urologist will have the discretion to biopsy Axumin avid lesions not detected by MRI.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

New York University Langone Medical Center

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The participant has undergone MRFTB of an MRI lesion at the Department of Urology or at NYU Langone Health within past 12 months and has signed informed consent to participate in the NYU Urology prostate biopsy database.
  • The most recent MRFTB of a PIRADS 4 or 5 lesion did not show clinically significant prostate cancer.

Exclusion criteria

  • The urologist who performed the initial MRFTB does not feel a repeat MRI is indicated.
  • Any contraindication to prostate biopsy including untreated urinary tract infection
  • Prior allergic reaction to axumin
  • Patient refuses MRI

Treatment and study plan

Fluciclovine PET/MRI

Diagnostic Test

It is unknown how many negative MRFTBs of PI-RADS 4 lesions are false negative biopsies or false positive tests.

Primary outcomes

  1. Number of patients with negative prostate biopsy

    Time frame: 12 Months

    This will be measured by determining is if PET imaging with 18-F fluciclovine (Axumin) identifies those men with prior negative MRFTBs of PI-RADS 4 and 5 lesions who harbor clinically significant prostate cancer

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 17, 2018
Registry last updated
Dec 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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