Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flotufolastat F 18 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- POSLUMA PET scan
- description
- Eligible participants will undergo a PSMA PET scan after infusion of POSLUMA imaging agent.
- interventionNames
- Drug: Flotufolastat F 18
Primary outcomes (3)
- measure
- Change in positive predictive value (PPV)
- timeFrame
- From enrollment to the end of treatment visit at roughly 12 weeks.
- description
- 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.
- measure
- Change in negative predictive value (NPV)
- timeFrame
- From enrollment to the end of treatment visit at roughly 12 weeks.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
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