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

NCT07220720 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB202401666
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

prostate cancer; posluma; pirads 2; pirads 3; prostate biopsy

Outcome Measures

Primary Outcomes (3)

• Change in positive predictive value (PPV)

  Evaluate the change in PPV for detecting clinically significant prostate cancer (csPCa) cores by comparing results from mpMRI alone (PIRADS 2 and 3 lesions) to the combination of mpMRI with flotufolastat F 18 PET-CT.

  From enrollment to the end of treatment visit at roughly 12 weeks.

• Change in negative predictive value (NPV)

  Measure the change in NPV for detecting csPCa cores by comparing mpMRI findings alone (PIRADS 2 and 3 lesions) with the combined approach of mpMRI and flotufolastat F 18 PET-CT.

  From enrollment to the end of treatment visit at roughly 12 weeks.

• Improvement in Accuracy

  Assess the improvement in accuracy (accuracy defined as \[(true positive + true negative) / total number of subjects\] when using the combined imaging approach of flotufolastat F 18 PET-CT with mpMRI versus mpMRI alone in patients with PIRADS 2 and 3 lesions.

  From enrollment to the end of treatment visit at roughly 12 weeks

Study Arms (1)

POSLUMA PET scan

EXPERIMENTAL

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

Drug: Flotufolastat F 18

Interventions

Flotufolastat F 18 DRUG

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.

Also known as: (18)F-rhPSMA-7.3, POSLUMA

POSLUMA PET scan

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is willing to provide signed informed consent and is able to comply with all required study-related procedures, where safe and feasible.
• The patient is male and at least 18 years of age.
• The patient has not previously undergone a prostate biopsy.
• The patient underwent a pelvic mpMRI within the last 90 days for the detection of potential prostate cancer (Pca).
• 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.
• The patient has PIRADS 2 and/or PIRADS 3 lesions detected by a board-certified radiologist.

You may not qualify if:

• Patients with a prior diagnosis of prostate cancer.
• 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.
• Patients participating in another interventional clinical trial within the past 30 days.
• Patients with known hypersensitivity to the active substance or any excipients of flotufolastat F 18 PET-CT.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health - Jacksonville

Jacksonville, Florida, 32209, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Shelby Sparks

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: October 24, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): July 15, 2030
• Study Completion (Estimated): November 15, 2032
• Last Updated: April 13, 2026

Record last verified: 2026-02

Locations

US (1)