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

University of Florida

Status and phase: Begins enrollment this month; Phase 2

Conditions: Prostate

Treatments: Drug: Flotufolastat F 18

Study type: Interventional

Funder types: Other

Identifiers

NCT07220720

IRB202401666

Details and patient eligibility

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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

POSLUMA PET scan

Experimental group

Description:

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

Treatment:

Drug: Flotufolastat F 18