NCT07220720 POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2/3 Lesions
| NCT ID | NCT07220720 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Florida |
| Condition | Prostate |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-11-04 |
| Primary Completion | 2030-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-11-04 with a primary completion date of 2030-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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. The patient has PIRADS 2 and/or PIRADS 3 lesions detected by a board-certified radiologist. Exclusion Criteria: 1. Patients with a prior diagnosis of prostate cancer. 2. 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. 3. Patients participating in another interventional clinical trial within the past 30 days. 4. Patients with known hypersensitivity to the active substance or any excipients of flotufolastat F 18 PET-CT.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07220720 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 100 Years, studying Prostate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07220720 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07220720 currently recruiting?
Yes, NCT07220720 is actively recruiting participants. Contact the research team at Urologyresearch@jax.ufl.edu for enrollment information.
Where is the NCT07220720 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT07220720 clinical trial?
NCT07220720 is sponsored by University of Florida. The trial plans to enroll 30 participants.