POSLUMA PET-CT to improve detection of significant prostate cancer in PIRADS 2/3 lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UF Health - Jacksonville
  Jacksonville, Florida, United States Recruiting

Study contacts

• Study coordinator: Shelby Sparks
• Email: Urologyresearch@jax.ufl.edu
• Phone: 904-244-7340

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.