POSLUMA PET Imaging for PI-RADS 3 Prostate Lesions
Public ClinicalTrials.gov record NCT07916311. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07916311
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 130 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 1, 2026 (Estimated)
- Primary completion
- Dec 2028 (Estimated)
- Completion
- Dec 2028 (Estimated)
- Last update posted
- Nov 4, 2026
2026 – 2028
United States locations
- U.S. sites
- 6
- U.S. states
- 1
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| SimonMed Imaging - Akos | Avondale | Arizona | 85392 | — |
| SimonMed Imaging - Chandler South | Chandler | Arizona | 85224 | — |
| SimonMed Imaging - Greenfield | Mesa | Arizona | 85206 | — |
| SimonMed Imaging - Central Phoenix | Phoenix | Arizona | 85004 | — |
| SimonMed Imaging - Kierland | Scottsdale | Arizona | 85254 | — |
| SimonMed Imaging - Surprise Stadium Village | Surprise | Arizona | 85374 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07916311, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 4, 2026 · Synced Nov 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07916311 live on ClinicalTrials.gov.