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NCT07285057 · ClinicalTrials.gov registry record · Phase 2
Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance
A Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT07285057: Recruiting Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by Icahn School of Medicine at Mount Sinai.
NCT07285057 is a Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 120 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07285057, a Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
This investigator-initiated, prospective study evaluates the diagnostic utility of rhPSMA-7.3 (¹⁸F) PET/CT (flotufolastat F18, marketed as POSLUMA®) in men with biopsy-proven, low-risk or favorable intermediate-risk prostate cancer managed with active surveillance. The study aims to determine whether the addition of PSMA-based PET/CT to standard multiparametric MRI (mpMRI) improves detection of clinically significant prostate cancer compared to MRI alone. Eligible participants will undergo rhPSMA-7.3 (¹⁸F) PET/CT and mpMRI prior to confirmatory prostate biopsy. Biopsies will target areas identified on MRI, PET/CT, or both, and histopathologic outcomes will serve as the reference standard. The study will assess lesion-level concordance between PET/CT, MRI, and pathology, and evaluate the predictive value of PET/CT for disease upgrading. Approximately 120 participants will be enrolled at Mount Sinai Hospital over 12 months. Study participation will involve one imaging visit, one confirmatory biopsy, and follow-up through review of clinical results. There is minimal risk to participants beyond standard diagnostic procedures. The study is funded jointly by the Icahn School of Medicine at Mount Sinai and Blue Earth Diagnostics, which provides the imaging agent flotufolastat F18 and technical support.
Primary Outcome
Detection rate measured by the proportion of participants with clinically significant prostate cancer (csPCa) (Grade Group ≥2) using rhPSMA-7.3 (¹⁸F) PET/CT compared to standard mpMRI confirmed on targeted or systematic biopsy Clinically significant prostate cancer is defined as Gleason Grade Group ≥ 2 (Gleason score ≥ 3+4 Predominantly well-formed glands with a lesser component of poorly-formed/fused/cribriform glands) based on histopathologic evaluation of biopsy cores obtained after PET/CT i
Conditions Studied
Interventions
- RADIATION rhPSMA-7.3 (18F) PET/CT Imaging (Flotufolastat F18, POSLUMA®)
- DRUG Flotufolastat F18
Study Locations (1)
New York
- Mount Sinai Hospital / Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2026-02-10 |
| Est. Completion | 2027-05-01 |
| Phase | Phase 2 |
What NCT07285057 shows while recruiting
NCT07285057 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (80% lower).
The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which rhPSMA-7.3 (18F) PET/CT Imaging (Flotufolastat F18, POSLUMA®) is the first listed.
NCT07285057 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT07285057 about?
NCT07285057 is a clinical study titled "Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance". This investigator-initiated, prospective study evaluates the diagnostic utility of rhPSMA-7.3 (¹⁸F) PET/CT (flotufolastat F18, marketed as POSLUMA®) in men with biopsy-proven, low-risk or favorable intermediate-risk prostate cancer managed with active surveillance. The study aims to determine whethe...
What is the current status of trial NCT07285057?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2026-02-10. Estimated completion is 2027-05-01.
What conditions does trial NCT07285057 study?
This clinical trial studies the following conditions: Prostate Cancer, Prostate Adenocarcinoma, Prostatic Neoplasms.
What interventions are being tested in trial NCT07285057?
The interventions under investigation include: rhPSMA-7.3 (18F) PET/CT Imaging (Flotufolastat F18, POSLUMA®) (RADIATION), Flotufolastat F18 (DRUG).
Who is sponsoring clinical trial NCT07285057?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07285057 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07285057's enrollment target sits among peer trials
120 301st of 735 higher than 427 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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