POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2/3 Lesions
ConditionProstate
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-100
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Flotufolastat F 18
DrugA 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: POSLUMA PET scanExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of treatment visit at roughly 12 weeks.2
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.
Time frame
From enrollment to the end of treatment visit at roughly 12 weeks.3
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.
Time frame
From enrollment to the end of treatment visit at roughly 12 weeksSponsors and contacts
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Source ClinicalTrials.gov