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Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance
Sponsor: Icahn School of Medicine at Mount Sinai
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.
Official title: Diagnostic Utility of rhPSMA-7.3 (18F) PET /CT Imaging in Patients With Prostate Cancer on Active Surveillance
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-02-10
Completion Date
2027-05-01
Last Updated
2026-02-23
Healthy Volunteers
No
Interventions
rhPSMA-7.3 (18F) PET/CT Imaging (Flotufolastat F18, POSLUMA®)
Participants will undergo a single rhPSMA-7.3 (¹⁸F) PET/CT scan using flotufolastat F18 (POSLUMA®), an FDA-approved PSMA-targeted radiotracer. The radiotracer will be administered intravenously at the standard diagnostic dose prior to PET/CT image acquisition. The scan will be performed according to institutional imaging protocols, approximately 50-70 minutes post-injection.
Flotufolastat F18
An FDA-approved PSMA-targeted radiotracer. The radiotracer will be administered intravenously at the standard diagnostic dose prior to PET/CT image acquisition.
Locations (1)
Mount Sinai Hospital / Icahn School of Medicine at Mount Sinai
New York, New York, United States