Actively Recruiting

Phase 2
Age: 18Years - 100Years
MALE
NCT07220720

POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2/3 Lesions

Led by University of Florida · Updated on 2026-04-13

30

Participants Needed

1

Research Sites

366 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2/3 Lesions

Who Can Participate

Age: 18Years - 100Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • The patient is willing to provide signed informed consent and can comply with study procedures safely and feasibly
  • The patient is male and at least 18 years old
  • The patient has not previously had a prostate biopsy
  • The patient had a pelvic mpMRI within the last 90 days to check for possible prostate cancer
  • The patient is scheduled for a targeted MRI/ultrasound biopsy before recruitment
  • The patient has PIRADS 2 and/or PIRADS 3 lesions identified by a board-certified radiologist
Not Eligible

You will not qualify if you...

  • Prior diagnosis of prostate cancer
  • Any medical condition or situation that could affect study data or prevent study participation
  • Participation in another interventional clinical trial within the past 30 days
  • Known allergy to flotufolastat F 18 or any of its ingredients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UF Health - Jacksonville

Jacksonville, Florida, United States, 32209

Actively Recruiting

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Research Team

S

Shelby Sparks

CONTACT

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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