RightFit
RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "These uncertain results include MRI results that showed a PIRADS 2 or PIRADS 3 area on the prostate."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a POSLUMA PET-CT scan can help find serious prostate cancer in men with unclear prostate MRI results called PI-RADS 2 or 3. It compares this scan with using MRI alone to guide a biopsy, a test that takes small tissue samples.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are male and at least 18 years old.
  • You agree to join, sign a consent form, and can safely follow the study steps.
  • You have never had a prostate biopsy.
  • You had a pelvic MRI to check for possible prostate cancer within the past 90 days.
  • You can have a prostate biopsy guided by MRI and ultrasound, and it was scheduled before you were approached about the study.
  • A board-certified doctor who reads scans found prostate areas rated PI-RADS 2 or 3 on your MRI.

Who can't join

  • You have been diagnosed with prostate cancer before.
  • The study doctor thinks a health condition or other issue could affect the study results or keep you from completing the study.
  • You took part in another trial testing a treatment or procedure within the past 30 days.
  • You have a known allergy to flotufolastat F 18, the drug used for this PET-CT scan, or any of its ingredients.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

FL