NCT07184970 · NYU Langone Health
PRISM Study: Prostate Recurrence Detection Using Imaging With PSMA PET/MRI Post-high Intensity Focused Ultrasound
What this study 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.
View original scientific description
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
Sensitivity of PSMA PET/MRI for detecting clinically significant prostate cancer at 12 months post HIFU, defined as the portion of patients with clinically significant cancer on the 12-month biopsy (reference standard) who had a positive PSMA PET/MRI.
Oncologic Control
Time frame: Month 12
Oncologic control at 12 months, defined as the absence of cancer, determined by the scheduled biopsy at 12 months.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 10, 2025 · Source of record for eligibility and locations