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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: Fluciclovine PET/MRI

• Registration Number: NCT03635866
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-15
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-17
• Study Start: 2019-01-02
• Primary Completion: 2020-10-09
• Study Completion: 2020-10-09
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
prior negative MRFTB of PI-RADS 4 and 5 lesions	Fluciclovine PET/MRI	Diagnosed withing 12 months of initial diagnostic cancer biopsy

Primary Outcome Measures

Name	Time	Method
Number of patients with negative prostate biopsy	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

Trial Locations

Locations (1)

New York University Langone Medical Center; 🇺🇸 New York, New York, United States