PRISM Study: Prostate Recurrence Detection Using Imaging With PSMA PET/MRI Post-high Inten
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 iden
| Condition(s) | Prostate Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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. |
| Ages | 40 Years to 95 Years |
| Sex | Male |
| Lead sponsor | NYU Langone Health |
| Locations | New York, New York, United States |
| Start date | 2025-10-08 |
| NCT ID | NCT07184970 |
| Official listing | https://clinicaltrials.gov/study/NCT07184970 |