Recruiting
Phase 2

rhPSMA-7.3

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07285057

Conditions

Prostatic Neoplasms

Prostate Cancer

Prostate Adenocarcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Flotufolastat F18

Study Details

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

Study ID

NCT07285057

Start date

Feb 10, 2026

Status verified date

Feb, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

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.

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 measure

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

Central Contacts and Locations

Central contacts

Neeraja Tillu, MBBS, MS, MCh.

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

Monali Fatterpekar, PhD

monali.fatterpekar@mountsinai.org

Locations

Mount Sinai Hospital / Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Neeraja Tillu, MBBS, MS, MCh

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

Monali Fatterpekar

Monali.Fatterpekar@mountsinai.org

Principal Investigator:

Ashutosh Tewari

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-02-23.