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

Not Applicable

Active, not recruiting

• Conditions: Prostate
• Interventions: Drug: Flotufolastat F 18

• Registration Number: NCT07220720
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-10-22
• Study First Posted: 2025-10-24
• Study Start: 2025-11-04
• Last Update Submitted: 2025-11-04
• Last Update Posted: 2025-11-06
• Primary Completion: 2030-07-15
• Study Completion: 2032-11-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
POSLUMA PET scan	Flotufolastat F 18	Eligible participants will undergo a PSMA PET scan after infusion of POSLUMA imaging agent.

Primary Outcome Measures

Name	Time	Method
Change in positive predictive value (PPV)	From enrollment to the end of treatment visit at roughly 12 weeks.	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.
Change in negative predictive value (NPV)	From enrollment to the end of treatment visit at roughly 12 weeks.	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.
Improvement in Accuracy	From enrollment to the end of treatment visit at roughly 12 weeks	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.

Trial Locations

Locations (1)

UF Health - Jacksonville; 🇺🇸 Jacksonville, Florida, United States