PET/MRI Study of Men With Highly Suspicious MRI Lesions That Showed no Clinically Significant Prostate Cancer Following MRI Fusion Targeted Biopsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Number of patients with negative prostate biopsy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
prior negative MRFTB of PI-RADS 4 and 5 lesions
Diagnosed withing 12 months of initial diagnostic cancer biopsy
Intervention: Fluciclovine PET/MRI (Diagnostic Test)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported