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.
Study Type
OBSERVATIONAL
Enrollment
60
NYU Langone Health
New York, New York, United States
RECRUITINGSensitivity of PSMA PET/MRI
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.
Time frame: Month 12
Oncologic Control
Oncologic control at 12 months, defined as the absence of cancer, determined by the scheduled biopsy at 12 months.
Time frame: Month 12
Portion of patients achieving a PSA reduction greater than 50%
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.
Time frame: Month 3, Month 6, Month 12
Change in IPSS (International Prostate Symptom Score)
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.
Time frame: Baseline, Month 12
Change in SHIM (Sexual Health Inventory for Men) Score
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.
Time frame: Baseline, Month 12
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