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

RECRUITINGSponsored by NYU Langone Health
Actively Recruiting
SponsorNYU Langone Health
Started2025-10-08
Est. completion2027-10-01
Eligibility
Age40 Years – 95 Years
SexMALE
Locations1 site
View on ClinicalTrials.gov →

NCT07184970

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.

Eligibility

Age: 40 Years – 95 YearsSex: MALE
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.

Conditions2

CancerProstate Cancer

Locations1 site

NYU Langone Health
New York, New York, 10016

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