NCT07916311Not yet recruiting
POSLUMA PET Imaging for PI-RADS 3 Prostate Lesions
Targeting the Gray Zone: Early Detection of Clinically Significant Prostate Cancer in PI-RADS 3 Patients Using PET Imaging With an 18F-Labeled Radiohybrid PSMA-Targeted Imaging Agent
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
This prospective, multicenter diagnostic accuracy study will evaluate whether POSLUMA (flotufolastat F 18) PET/MRI or PET/CT can detect clinically significant prostate cancer, defined as Gleason score 7 or higher, in adult men with PI-RADS 3 lesions on recent multiparametric MRI and a clinical indication for prostate biopsy. Participants will undergo a research-only POSLUMA PET scan before targeted and systematic prostate biopsy. PET imaging metrics and clinical variables will be compared with histopathology. Research PET results will not be used to guide clinical management or replace standard diagnostic procedures.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 29 Oct 2026
- Start date
- 1 Dec 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- SimonMed Imaging
- Diseases
- Prostate cancer
- NCT number
- NCT07916311
What you commit to
- Study type: Interventional
- Planned participants: 130
- From 1 Dec 2026 to the primary completion date, Dec 2028
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior diagnosis or treatment of prostate cancer
Other illness
- Any medical condition that may interfere with study procedures
Other
- PI-RADS 4 or 5 lesion
- Negative MRI, defined as PI-RADS 1 or 2
- Contraindication to PSMA PET or prostate biopsy
- Contraindication to both MRI and CT
Who the study is looking for
- Male, age 18 years or older
- PI-RADS 3 lesion diagnosed by multiparametric MRI within the past 4 weeks
- Clinical indication for prostate biopsy
- Undergoing targeted biopsy and systematic biopsy as part of the routine clinical pathway
- Able to provide written informed consent
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SimonMed Imaging - Akos | Avondale | United States | Unknown status |
| SimonMed Imaging - Chandler South | Chandler | United States | Unknown status |
| SimonMed Imaging - Greenfield | Mesa | United States | Unknown status |
| SimonMed Imaging - Central Phoenix | Phoenix | United States | Unknown status |
| SimonMed Imaging - Kierland | Scottsdale | United States | Unknown status |
| SimonMed Imaging - Surprise Stadium Village | Surprise | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.