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NCT Number: NCT07184970

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–95 year

Sex eligibility

Male

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Portion of patients achieving a PSA reduction greater than 50%

    Time frame: 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.

  2. Change in IPSS (International Prostate Symptom Score)

    Time frame: 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.

  3. Change in SHIM (Sexual Health Inventory for Men) Score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Majlinda Tafa

CONTACT

[email protected]

(646) 825-6338

Wei Phin Tan, MD

CONTACT

[email protected]

(646) 825-6325

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 22, 2025
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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