NCT07285057 · Icahn School of Medicine at Mount Sinai
Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance
What this study is about
This investigator-initiated, forward-looking 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.
View original scientific description
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.
Interventions
RADIATION
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.
DRUG
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.
Primary outcome measures
Proportion of participants with Grade Group ≥ 2
Time frame: Up to 3 months after PET/CT imaging
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 imaging.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male participants aged ≥18 years.
- Histologically confirmed diagnosis of prostate adenocarcinoma.
- Classified as 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.
Exclusion criteria
- A 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. \*\
- Significant intercurrent morbidity refers to a substantial medical condition or complication that arises during a study or treatment, which is severe enough to impact the patient's participation, treatment outcomes, or overall prognosis. These conditions may be unrelated to the primary disease but can influence clinical decision-making, treatment efficacy, and patient safety. Examples include major infections, cardiovascular events, organ failure, or significant worsening of pre-existing comorbidities (https://doi.org/10.1016/S1053-4296(03)00031-6).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Agent(s) or other agents used in study.
Where
- New York, New York
Collaborators
Blue Earth Diagnostics
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 23, 2026 · Source of record for eligibility and locations