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
Qualifiers
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
Treatments tested in this trial
- Flotufolastat F 18
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov