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.
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
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.
Only male patients will be included in this study. The expected age range will be 40-95. There is no enrollment restrictions based upon race or ethnic origin.
Cohort
Prospective
Not listed
Sensitivity 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.
Oncologic Control
Oncologic control at 12 months, defined as the absence of cancer, determined by the scheduled biopsy at 12 months.
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.
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.
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.
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