Actively Recruiting
Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-02-23
120
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
B
Blue Earth Diagnostics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 years or older
- Histologically confirmed diagnosis of prostate adenocarcinoma
- Low-risk or favorable intermediate-risk prostate cancer according to NCCN criteria (Low-risk: Grade Group 1, PSA <10 ng/mL, cT1-T2a; Favorable intermediate-risk: Grade Group 2, PSA 10-20 ng/mL, cT2b-c)
- Currently managed with active surveillance
- Able and willing to undergo rhPSMA-7.3 (18F) PET/CT imaging, mpMRI, and confirmatory prostate biopsy
- Able to provide written informed consent
You will not qualify if you...
- History of other active malignancy within the last 5 years, except for non-melanoma skin cancer
- Contraindication to 3-T mpMRI
- Significant intercurrent morbidity limiting compliance with study protocols
- History of allergic reactions to compounds similar to the study agents or other agents used in the study
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Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital / Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
N
Neeraja Tillu, MBBS, MS, MCh.
CONTACT
M
Monali Fatterpekar, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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