Recruiting
Phase 2

PET-CT Scan

Sponsor:

University of Florida

Code:

NCT07220720

Conditions

Prostate

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Flotufolastat F 18

Study Details

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.

Conditions

Prostate

Study ID

NCT07220720

Start date

Nov 4, 2025

Status verified date

Feb, 2026

Completion date

Nov 15, 2032

Anticipated

Primary completion date

Jul 15, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: POSLUMA PET scan

Eligible participants will undergo a PSMA PET scan after infusion of POSLUMA imaging agent.

Interventions

Flotufolastat F 18

A PSMA-targeted PET imaging agent used to detect and locate prostate cancer during PET scans that will be administered one time to each study subject.

Primary outcome measure

  • Change in positive predictive value (PPV) [ Time Frame: From enrollment to the end of treatment visit at roughly 12 weeks. ]
  • Change in negative predictive value (NPV) [ Time Frame: From enrollment to the end of treatment visit at roughly 12 weeks. ]
  • Improvement in Accuracy [ Time Frame: From enrollment to the end of treatment visit at roughly 12 weeks ]

Central Contacts and Locations

Central contacts

Shelby Sparks

904-244-7340Urologyresearch@jax.ufl.edu

Locations

UF Health - Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Shelby Sparks

904-244-7340shelby.sparks@ufhealth.org

Principal Investigator:

Kethandapatti Balaji, MD

More Information

Sponsor

University of Florida

Last update posted

Apr 13, 2026

Last verified

Feb, 2026

Keywords

  • prostate cancer
  • posluma
  • pirads 2
  • pirads 3
  • prostate biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-04-13.