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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07184970

Enrollment

Registered

2025-09-22

Start date

2025-10-08

Completion date

2028-10-01

Last updated

2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

40 Years to 95 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity of PSMA PET/MRI	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	Month 12	Oncologic control at 12 months, defined as the absence of cancer, determined by the scheduled biopsy at 12 months.

Secondary

Measure	Time frame	Description
Portion of patients achieving a PSA reduction greater than 50%	Month 3, Month 6, Month 12	The portion of patients achieving a PSA reduction greater than 50% from pre-HIFU baseline measured at 3 months, 6 months, and every 6 months post-HIFU.
Change in IPSS (International Prostate Symptom Score)	Baseline, Month 12	The IPSS (International Prostate Symptom Score) assesses lower urinary tract symptoms (LUTS). A total IPSS score of 1-7 is considered mild, 8-19 moderate, and 20-35 severe.
Change in SHIM (Sexual Health Inventory for Men) Score	Baseline, Month 12	The SHIM (Sexual Health Inventory for Men) score measures erectile dysfunction (ED). A SHIM score of 22-25 indicates no ED, 17-21 is mild, 12-16 mild to moderate, 8-11 moderate, and 1-7 severe ED.

Countries

United States

Contacts

CONTACTMajlinda Tafa

Majlinda.Tafa@nyulangone.org(646) 825-6338

CONTACTWei Phin Tan, MD

weiphin.tan@nyulangone.org(646) 825-6325

PRINCIPAL_INVESTIGATORWei Phin Tan

NYU Langone Health

Outcome results