PSMA PET/CT plus MRI to find higher‑grade prostate cancer in men on active surveillance
Diagnostic Utility of rhPSMA-7.3 (18F) PET /CT Imaging in Patients With Prostate Cancer on Active Surveillance
This study tries adding rhPSMA-7.3 (flotufolastat F18) PET/CT to standard mpMRI to see if it finds higher-grade prostate cancer in men on active surveillance.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07285057 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Men aged 18 or older with biopsy-proven low-risk or favorable intermediate-risk prostate adenocarcinoma who are currently managed on active surveillance and can undergo mpMRI, rhPSMA-7.3 PET/CT, and confirmatory biopsy are ideal candidates.
Not a fit: Men with known high-risk disease, contraindications to 3-T mpMRI or PET/CT, recent other active malignancies, or severe comorbidities that prevent imaging or biopsy are unlikely to benefit.
Why it matters
Potential benefit: If successful, adding PSMA PET/CT could detect occult or higher-grade cancers earlier and help guide timely decisions about treatment versus continued surveillance.
How similar studies have performed: PSMA PET/CT has improved prostate cancer detection and staging in prior studies and early work suggests it can find lesions missed by MRI, although rhPSMA-7.3 is a newer tracer with more limited data in active surveillance populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.