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

NCT03635866 | Completed

• 1 other identifier: 18-00601
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Number of patients with negative prostate biopsy

  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

  12 Months

Study Arms (1)

prior negative MRFTB of PI-RADS 4 and 5 lesions

EXPERIMENTAL

Diagnosed withing 12 months of initial diagnostic cancer biopsy

Diagnostic Test: Fluciclovine PET/MRI

Interventions

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.

prior negative MRFTB of PI-RADS 4 and 5 lesions

Eligibility Criteria

• Age: 18 Years - 100 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Herbert Lepor, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 17, 2018
• Study Start: January 2, 2019
• Primary Completion: October 9, 2020
• Study Completion: October 9, 2020
• Last Updated: December 7, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)