PRISM Study: Prostate Recurrence Detection Using Imaging With PSMA PET/MRI Post-high Intensity Focused Ultrasound
Recruiting · NCT07184970 · Observational (researchers observe without assigning treatment) · Lead sponsor: NYU Langone Health
View the official record on ClinicalTrials.gov →What this trial is about
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 take part
Age range
40 Years to 95 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed across 1 US state.
- NYU Langone Health - New York, New York, United States