NCT07220720RecruitingPhase 2
POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2/3 Lesions
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
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 3 Jun 2025
- Start date
- 4 Nov 2025
- Primary completion date
- 15 Jul 2030
- Lead sponsor
- University of Florida
- Diseases
- Prostate cancer
- NCT number
- NCT07220720
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 4 Nov 2025 to the primary completion date, 15 Jul 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a prior diagnosis of prostate cancer.
Other illness
- Patients with any medical condition or circumstance that, in the investigator's opinion, could compromise the study data or prevent the patient from fulfilling the study requirements.
- Patients with known hypersensitivity to the active substance or any excipients of flotufolastat F 18 PET-CT.
Other
- Patients participating in another interventional clinical trial within the past 30 days.
Who the study is looking for
- The patient is willing to provide signed informed consent and is able to comply with all required study-related procedures, where safe and feasible.
- The patient is male and at least 18 years of age.
- The patient has not previously undergone a prostate biopsy.
- The patient underwent a pelvic mpMRI within the last 90 days for the detection of potential prostate cancer (Pca).
- 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.
- The patient has PIRADS 2 and/or PIRADS 3 lesions detected by a board-certified radiologist.
Age in the registry: 18 years to 100 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UF Health Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.