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

NCT ID: NCT07220720

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-04

Study Completion Date

2032-11-15

Brief Summary

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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

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Conditions

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Prostate

Keywords

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prostate cancer posluma pirads 2 pirads 3 prostate biopsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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POSLUMA PET scan

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

Group Type EXPERIMENTAL

Flotufolastat F 18

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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(18)F-rhPSMA-7.3 POSLUMA

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UF Health - Jacksonville

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB202401666

Identifier Type: -

Identifier Source: org_study_id