PRISM Study: Prostate Recurrence Detection Using Imaging With PSMA PET/MRI Post-high Intensity Focused Ultrasound
Status
RECRUITING
Phase
Age
40 - 95 Years
Enrollments
60Conditions
Prostate CancerSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Central Contacts
- Majlinda Tafa
- (646) 825-6338
- [email protected]
Principal Investigator
- Wei Phin Tan
Eligibility 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.
Study Plan
Men with Prostate Cancer
Patients undergoing High-Intensity Focused Ultrasound (HIFU) for focal therapy of prostate cancer. Participants will be followed for one-year post-treatment, with regular monitoring through various clinical assessments.
Outcome Measures
Primary Outcome Measures
Sensitivity of PSMA PET/MRI
Oncologic Control
Secondary Outcome Measures
Portion of patients achieving a PSA reduction greater than 50%
Change in IPSS (International Prostate Symptom Score)
Change in SHIM (Sexual Health Inventory for Men) Score
Timeline
Last Updated
October 10, 2025Start Date
September 22, 2025Today
March 13, 2026Completion Date ( Estimated )
October 1, 2028
Sponsors of this trial
Lead Sponsor
NYU Langone Health
RECRUITING 
18 - 80 Years