PSMA PET/CT plus MRI to find higher‑grade prostate cancer in men on active surveillance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center Phase 2 study will enroll about 120 men on active surveillance for low-risk or favorable intermediate-risk prostate cancer at Mount Sinai Hospital. Participants undergo rhPSMA-7.3 (18F) PET/CT and 3-T multiparametric MRI before a confirmatory prostate biopsy. Biopsies target lesions seen on MRI, PET/CT, or both, with histopathology as the reference standard. The study will compare lesion-level concordance between PET/CT, MRI, and pathology and test whether PET/CT improves prediction of disease upgrading.

Why it matters

Who can join: the full rules

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 it's running

• Mount Sinai Hospital / Icahn School of Medicine at Mount Sinai
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Ashutosh Tewari — Icahn School of Medicine at Mount Sinai
• Study coordinator: Neeraja Tillu, MBBS, MS, MCh.
• Email: neeraja.tillu@mountsinai.org
• Phone: 646-799-1870

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.