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RecruitingObservational

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

NCT ID: NCT07184970Sponsor: NYU Langone HealthLast updated: 2025-10-10

Summary

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.

Arms & interventions

Outcome measures

Primary

  • Sensitivity of PSMA PET/MRI

    Sensitivity of PSMA PET/MRI for detecting clinically significant prostate cancer at 12 months post HIFU, defined as the portion of patients with clinically significant cancer on the 12-month biopsy (reference standard) who had a positive PSMA PET/MRI.

    Time frame: Month 12

  • Oncologic Control

    Oncologic control at 12 months, defined as the absence of cancer, determined by the scheduled biopsy at 12 months.

    Time frame: Month 12

Secondary

  • Portion of patients achieving a PSA reduction greater than 50%

    Time frame: Month 3, Month 6, Month 12

  • Change in IPSS (International Prostate Symptom Score)

    Time frame: Baseline, Month 12

  • Change in SHIM (Sexual Health Inventory for Men) Score

    Time frame: Baseline, Month 12

Eligibility criteria

Sex: MaleAge: 40 Years to 95 Years
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 locations (1)

NYU Langone Health

New York, New York, 10016

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