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

NCT ID: NCT07184970

Last Updated: 2025-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-08

Study Completion Date

2028-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Men with Prostate Cancer

Patients undergoing High-Intensity Focused Ultrasound (HIFU) for focal therapy of prostate cancer. Participants will be followed for one-year post-treatment, with regular monitoring through various clinical assessments.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

95 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei Phin Tan

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Majlinda Tafa

Role: CONTACT

(646) 825-6338

Wei Phin Tan, MD

Role: CONTACT

(646) 825-6325

Other Identifiers

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24-01935

Identifier Type: -

Identifier Source: org_study_id

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