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PRISM Study: Prostate Recurrence Detection Using Imaging With PSMA PET/MRI Post-HIFU

This study, called the PRISM Study, is looking at how well a special type of imaging called PSMA PET/MRI can find prostate cancer that has come back after treatment with High-Intensity Focused Ultrasound (HIFU). It compares PSMA PET/MRI to standard MRI to see if it's better at detecting if the treatment was not fully successful. You might be able to join if you are a man between 40 and 95 years old with localized prostate cancer that has a certain grade (Gleason score 3+4 or higher), and you are having HIFU treatment. The study will look at how well these imaging methods work after 12 months. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information without giving any specific treatments. It plans to include 60 participants.
What's involved
You would need to agree to follow-up protocols, which include PSA testing, imaging, and biopsies.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months to measure the sensitivity of PSMA PET/MRI and oncologic control.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07184970

PRISM Study: Prostate Recurrence Detection Using Imaging With PSMA PET/MRI Post-high Intensity Focused Ultrasound

Recruiting
Not specifiedAges 40–95Observational
NYU Langone Health
~60 participants
Updated 2026-08-27 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity of PSMA PET/MRI
Measured over Month 12
+1 more outcome measured

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Wei Phin Tan · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Majlinda Tafa
[email protected]
(646) 825-6338
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Sensitivity of PSMA PET/MRIMonth 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 ControlMonth 12

    Oncologic control at 12 months, defined as the absence of cancer, determined by the scheduled biopsy at 12 months.