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Clinical trial Recruiting at 1 site Observational Ages 40 to 95 Men only

Detecting prostate recurrence after HIFU with PSMA PET/MRI

Official title: Prostate Recurrence Detection Using Imaging With PSMA PET/MRI Post-high Intensity Focused Ultrasound

Run by NYU Langone Health · NCT07184970 · Data updated 2026-11-12

This project will test whether PSMA PET/MRI finds prostate cancer recurrence better than standard MRI in men treated with focal HIFU therapy.

Quick facts

Study typeObservational
Ages40 Years to 95 Years
SexMen only
Enrollment60 (estimated)
SponsorNYU Langone Health
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedOctober 8, 2025
Main results expectedOctober 1, 2027
Study endsOctober 1, 2028
Registry record updatedAugust 27, 2026
Trial IDNCT07184970 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men aged 40–95 with biopsy-proven, unifocal localized prostate cancer Grade Group ≥2 who are undergoing focal HIFU, have PSA <20, no metastatic disease, and can tolerate MRI and PET procedures are ideal candidates.

Probably not a fit

Patients with metastatic disease, multifocal prostate cancer, allergy to the PET tracer or gadolinium, or who cannot tolerate MRI are unlikely to benefit from this imaging comparison.

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

What this trial studies

This observational study at NYU Langone will compare PSMA PET/MRI with standard multiparametric MRI to detect focal therapy failure one year after high-intensity focused ultrasound (HIFU). Eligible men will undergo scheduled imaging and follow-up, with targeted biopsies as needed to confirm suspected recurrence. The main outcome is sensitivity of each imaging method for identifying recurrent or persistent cancer, using biopsy or clinical follow-up as reference standards. All scans are performed at the study site and investigators will analyze concordance and missed lesions between modalities.

Why it matters

Potential benefit: If successful, this approach could catch recurrent prostate cancer earlier or more accurately after HIFU, helping guide targeted retreatment.

How similar studies have gone: PSMA PET has improved detection in post-treatment biochemical recurrence and PET/MRI shows promising sensitivity, but its specific performance for detecting focal HIFU failure is less well established and remains under study.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male patients 40-95 years of age with biopsy-confirmed localized prostate cancer.
* Grade Group ≥2 (Gleason score 3+4 or higher).
* Unifocal disease visible on mpMRI.
* Patients undergoing HIFU as part of their standard of care
* PSA \<20 ng/mL.
* No metastatic disease on PSMA PET/CT
* Willingness to comply with follow-up protocols (PSA testing, imaging, biopsies).

Exclusion Criteria:

* Evidence of metastatic disease on PSMA PET/CT.
* Allergy to POSLUMA or gadolinium.
* Inability to tolerate MRI due to claustrophobia or posture/back-hip issues.

Where it's running

  • NYU Langone Health
    New York, New York, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.