← Back to Search

prior negative MRFTB of PI-RADS 4 and 5 lesions for Prostate Cancer

N/A
Waitlist Available
Led By Herbert Lepor, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients with negative prostate biopsy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: prior negative MRFTB of PI-RADS 4 and 5 lesionsExperimental Treatment1 Intervention
Diagnosed withing 12 months of initial diagnostic cancer biopsy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluciclovine PET/MRI
2019
N/A
~40

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,403 Previous Clinical Trials
855,090 Total Patients Enrolled
26 Trials studying Prostate Cancer
5,279 Patients Enrolled for Prostate Cancer
Herbert Lepor, MDPrincipal InvestigatorNYU Langone Medical Center
2 Previous Clinical Trials
57 Total Patients Enrolled
2 Trials studying Prostate Cancer
57 Patients Enrolled for Prostate Cancer
~5 spots leftby Oct 2025