Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prior negative MRFTB of PI-RADS 4 and 5 lesions | Experimental | Diagnosed withing 12 months of initial diagnostic cancer biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Herbert Lepor, MD | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Langone Medical Center | New York | New York | 10016 | United States |
The objective of the study is: to determine if PET imaging with 18-F fluciclovine identifies those men with prior negative MRFTBs of PI-RADS 4&5
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |