Inclusion of POSLUMA® ((18)F-rhPSMA-7.3) PET-CT Imaging Improves Diagnostic Accuracy of Clinically-Significant Prostate Cancer Diagnosis in Men With PIRADS 2 and 3 Lesions on MRI

University of Florida

Summary

The goal of this study to determine if using the (18)F-rhPSMA-7.3 PET-CT scan can improve the ability to spot serious prostate cancer in patients who have uncertain MRI results. These uncertain results include MRI results that showed a PIRADS 2 or PIRADS 3 area on the prostate. The investigators want to find out if this new test is better to detect prostate cancer than just doing a biopsy based on MRI alone.

Eligibility

Age range: 18–100 years
Sex: Male
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. The patient is willing to provide signed informed consent and is able to comply with all required study-related procedures, where safe and feasible. 2. The patient is male and at least 18 years of age. 3. The patient has not previously undergone a prostate biopsy. 4. The patient underwent a pelvic mpMRI within the last 90 days for the detection of potential prostate cancer (Pca). 5. The patient is a candidate for a targeted MRI/US biopsy and is scheduled to undergo the procedure. Only patients scheduled for a biopsy before recruitment will be considered candidates. 6. T…

Interventions

Drug
Flotufolastat F 18
A PSMA-targeted PET imaging agent used to detect and locate prostate cancer during PET scans that will be administered one time to each study subject.

Location

UF Health - Jacksonville
Jacksonville, Florida
shelby.sparks@ufhealth.org 904-244-7340

Inclusion of POSLUMA® ((18)F-rhPSMA-7.3) PET-CT Imaging Improves Diagnostic Accuracy of Clinically-Significant Prostate Cancer Diagnosis in Men With PIRADS 2 and 3 Lesions on MRI

Summary

Eligibility

Interventions

Location

Run this study?

Details

Conditions