Actively Recruiting
Inclusion of POSLUMA (18F-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
Led by University of Florida · Updated on 2026-04-13
30
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether the (18)F-rhPSMA-7.3 PET-CT scan, also known as POSLUMA, can better detect significant prostate cancer in men who have uncertain MRI results showing PIRADS 2 or 3 lesions. The study aims to find out if this new imaging test improves detection compared to the standard MRI-based biopsy approach. This trial is a Phase 2 interventional study sponsored by the University of Florida. Participants will receive a single infusion of the PSMA-targeted PET imaging agent called Flotufolastat F 18, followed by a POSLUMA PET scan to locate prostate cancer. The study focuses on men who are scheduled for a targeted MRI/ultrasound biopsy based on recent pelvic multiparametric MRI findings. This imaging agent is administered one time per participant to assess its diagnostic accuracy. During the study, researchers will measure changes in the positive and negative predictive values and overall accuracy of prostate cancer detection from enrollment to about 12 weeks later at the end of treatment visit. Participants will have imaging and biopsy procedures as scheduled, and the study will monitor how well the PET scan detects clinically significant prostate cancer. The total participation time is roughly 12 weeks, with safety and diagnostic outcomes evaluated throughout this period.
CONDITIONS
Brief Title
POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2/3 Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient is willing to provide signed informed consent and comply with all study procedures where safe and feasible
- Male patients aged 18 years or older
- No previous prostate biopsy
- Pelvic multiparametric MRI performed within the last 90 days for potential prostate cancer detection
- Candidate for targeted MRI/ultrasound biopsy and scheduled to undergo the procedure before recruitment
- Presence of PIRADS 2 and/or PIRADS 3 lesions detected by a board-certified radiologist
You will not qualify if you...
- Prior diagnosis of prostate cancer
- Any medical condition or circumstance that could compromise study data or prevent fulfilling study requirements
- Participation in another interventional clinical trial within the past 30 days
- Known hypersensitivity to flotufolastat F 18 or any of its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single day
Participants receive a single infusion of the POSLUMA imaging agent followed by a PSMA PET scan to detect and locate prostate cancer lesions.
1 visit (in-person)
Duration - Up to 12 weeks
Participants are monitored through the end of treatment visit to assess diagnostic outcomes such as positive and negative predictive values and overall accuracy.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
UF Health - Jacksonville
Jacksonville, Florida, United States, 32209
Actively Recruiting
Research Team
S
Shelby Sparks
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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