POSLUMA PET-CT to improve detection of significant prostate cancer in 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
This test will see if POSLUMA (18F-rhPSMA-7.3) PET-CT can better find clinically significant prostate cancer in men with uncertain PIRADS 2 or 3 MRI results who are scheduled for a targeted biopsy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Male |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT07220720 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional protocol gives biopsy‑naïve men with PIRADS 2 or 3 findings on recent mpMRI a POSLUMA (18F-rhPSMA-7.3) PET-CT scan prior to their planned MRI/ultrasound-targeted prostate biopsy. Investigators will compare PET-CT imaging findings against biopsy histopathology to determine whether PET adds diagnostic value beyond MRI-based targeting alone. Eligible participants must have had pelvic mpMRI within 90 days and be scheduled for a targeted biopsy. The study uses Flotufolastat F 18 at a single site (UF Health–Jacksonville) to collect imaging and correlate with biopsy results.
Who should consider this trial
Good fit: Biopsy‑naïve men aged 18 or older with a pelvic mpMRI within the past 90 days showing PIRADS 2 and/or 3 lesions who are scheduled for an MRI/US-targeted prostate biopsy.
Not a fit: Men with a prior prostate cancer diagnosis, those who have already had a prostate biopsy, patients with PIRADS 4–5 disease, or individuals unable to undergo PET-CT or travel to the study site are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could help doctors find significant prostate cancers more accurately and reduce unnecessary or missed biopsies.
How similar studies have performed: Other PSMA PET agents have shown improved prostate cancer detection and staging in many settings, but using 18F-rhPSMA-7.3 specifically for PIRADS 2/3 lesions is relatively novel and has limited prior data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jacksonville, Florida
- UF Health - Jacksonville — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Shelby Sparks
- Email: Urologyresearch@jax.ufl.edu
- Phone: 904-244-7340
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.