PRISM Study: Prostate Recurrence Detection Using Imaging With PSMA PET/MRI Post-high Intensity Focused Ultrasound
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 40 years — 95 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prostate Recurrence Detection Using Imaging With PSMA PET/MRI Post-high Intensity Focused Ultrasound
Overview
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.
Primary outcome measures
- Sensitivity of PSMA PET/MRI [Time frame: Month 12]
- Oncologic Control [Time frame: Month 12]
Secondary outcome measures (3)
- 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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT07184970 · 24-01935