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

This study is looking at how well a special type of scan, called rhPSMA-7.3 (18F) PET/CT, helps doctors find prostate cancer that might be more serious. This scan uses a substance called flotufolastat F18 (also known as POSLUMA®), which is approved by the FDA. You might be able to join if you are a man, 18 or older, with prostate cancer that has been confirmed by a biopsy and is considered low-risk or favorable intermediate-risk. You should also be currently managed with active surveillance, meaning your doctors are watching your cancer closely without immediate treatment. The main goal is to see if adding this PET/CT scan to standard MRI (magnetic resonance imaging) helps detect more significant prostate cancer. The study is currently unclear on its recruitment status.

Study design
This is a single-center study that aims to enroll 120 participants. It is an interventional study, meaning participants will receive a specific intervention.
What's involved
Participants will have one rhPSMA-7.3 (18F) PET/CT scan after receiving an intravenous injection of flotufolastat F18. They will also undergo an mpMRI and a confirmatory prostate biopsy.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 3 months after their PET/CT imaging to assess the proportion of participants with Grade Group ≥ 2.

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NCT07285057

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

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Icahn School of Medicine at Mount Sinai
~120 participants
Updated 2026-02-23 on ClinicalTrials.gov
What's tested:rhPSMA-7.3 (18F) PET/CT Imaging (Flotufolastat F18, POSLUMA®)Flotufolastat F18

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants with Grade Group ≥ 2
Measured over Up to 3 months after PET/CT imaging

Conditions

Prostatic Neoplasms
Prostate Cancer
Prostate Adenocarcinoma

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Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Ashutosh Tewari · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Neeraja Tillu, MBBS, MS, MCh.
[email protected]
646-799-1870
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Agent(s) or other agents used in study.

What this trial measures

  • Proportion of participants with Grade Group ≥ 2Up 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.