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

NCT07285057 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY-25-00518
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostatic Neoplasms; Prostate Cancer; Prostate Adenocarcinoma

Keywords

Prostate cancer; Prostatic neoplasms; Active surveillance; PSMA PET/CT; rhPSMA-7.3; Prostate biopsy

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with Grade Group ≥ 2

  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.

  Up to 3 months after PET/CT imaging

Secondary Outcomes (8)

• Incremental detection rate of csPCa by PET/CT over MRI

  up to 6 months

• Lesion-level concordance between rhPSMA-7.3 (¹⁸F) PET/CT, multiparametric MRI, and histopathology

  Up to 6 months following enrollment (from baseline imaging to confirmatory biopsy)

• Predictive value of PET SUVmax for detecting clinically significant disease

  Baseline to 6 months

• Sensitivity

  Baseline to 6 months

• Specificity

  Baseline to 6 months

Study Arms (1)

rhPSMA-7.3 (18F) PET/CT Imaging

EXPERIMENTAL

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.

Radiation: rhPSMA-7.3 (18F) PET/CT Imaging (Flotufolastat F18, POSLUMA®); Drug: Flotufolastat F18

Interventions

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.

Also known as: POSLUMA®

rhPSMA-7.3 (18F) PET/CT Imaging

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.

rhPSMA-7.3 (18F) PET/CT Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Blue Earth Diagnostics: collaborator

Study Sites (1)

Mount Sinai Hospital / Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ashutosh Tewari

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neeraja Tillu, MBBS, MS, MCh.

CONTACT

646-799-1870; neeraja.tillu@mountsinai.org

Monali Fatterpekar, PhD

CONTACT

monali.fatterpekar@mountsinai.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label diagnostic imaging study. Neither participants nor investigators are blinded to the imaging procedures. However, imaging interpretation will be performed independently - PET/CT scans will be reviewed by nuclear medicine physicians blinded to MRI findings, and MRI scans will be reviewed by radiologists blinded to PET/CT results. Pathologists evaluating biopsy specimens will be blinded to imaging results to minimize interpretation bias.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and System Chair

Model Details: This is a single-arm, prospective diagnostic imaging study in which all enrolled participants will undergo rhPSMA-7.3 (¹⁸F) PET/CT and standard multiparametric MRI prior to confirmatory prostate biopsy. Each participant serves as an own control for within-patient comparison of imaging modalities. No randomization or separate intervention arms are used.

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 16, 2025
• Study Start: February 10, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)