Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07285057
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rhPSMA-7.3 (18F) PET/CT Imaging (Flotufolastat F18, POSLUMA®) — RADIATION
    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 — DRUG
    An FDA-approved PSMA-targeted radiotracer. The radiotracer will be administered intravenously at the standard diagnostic dose prior to PET/CT image acquisition.

Study Details

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.

Key Dates

Start date
Feb 10, 2026
Status verified
Feb 2026
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: rhPSMA-7.3 (18F) PET/CT Imaging
    Participants in this arm will undergo rhPSMA-7.3 (¹⁸F) PET/CT (flotufolastat F18, POSLUMA®) imaging and standard multiparametric MRI prior to confirmatory prostate biopsy. All participants receive the same imaging procedures; there are no control or comparison arms.

Primary Outcome Measure

Proportion of participants with Grade Group ≥ 2 [ Time Frame: Up to 3 months after PET/CT imaging ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai Hospital / Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Neeraja Tillu, MBBS, MS, MCh
[email protected]
646-799-1870
Monali Fatterpekar
[email protected]
Ashutosh Tewari (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Mount Sinai Hospital / Icahn School of Medicine at Mount Sinai· New York, NY

Related Studies