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Recruiting NCT07220720

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

Phase II Interventional Prostate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Flotufolastat F 18.
Who it may be relevant to
Registry conditions: Prostate. Basic parameters: 18 years — 100 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Inclusion of POSLUMA® ((18)F-rhPSMA-7.3) PET-CT Imaging Improves Diagnostic Accuracy of Clinically-Significant Prostate Cancer Diagnosis in Men With PIRADS 2 and 3 Lesions on MRI

Overview

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.

Interventions

  • Drug 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 measures

  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • UF Health - Jacksonville — Jacksonville

Identifiers

NCT: NCT07220720 · IRB202401666

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗