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

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

Recruiting
40-95 years
Male
Phase N/A
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Overview

The purpose of this study is to compare the sensitivity of PSMA PET/MRI and standard MRI in detecting focal therapy failure in the prostate one year after High-Intensity Focused Ultrasound (HIFU) treatment. Specifically, the study aims to evaluate whether PSMA PET/MRI offers a higher sensitivity than MRI alone for identifying recurrence or failure in patients undergoing focal therapy.

Eligibility

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.

Study details
    Prostate Cancer

NCT07184970

NYU Langone Health

15 October 2025

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