[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607162":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":28,"studyPopulation":32,"armGroups":33,"interventions":28,"overallOfficials":37,"centralContacts":41,"locations":51,"responsibleParty":64,"collaborators":28,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":28,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":28,"studyType":79,"phases":28,"briefSummary":80,"conditions":81,"keywords":28,"overallStatus":53,"whyStopped":28,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"NYU Langone Health","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":28},[9,13],{"measure":10,"description":11,"timeFrame":12},"Sensitivity of PSMA PET\u002FMRI","Sensitivity of PSMA PET\u002FMRI 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\u002FMRI.","Month 12",{"measure":14,"description":15,"timeFrame":12},"Oncologic Control","Oncologic control at 12 months, defined as the absence of cancer, determined by the scheduled biopsy at 12 months.",[17,21,25],{"measure":18,"description":19,"timeFrame":20},"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.","Month 3, Month 6, Month 12",{"measure":22,"description":23,"timeFrame":24},"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.","Baseline, Month 12",{"measure":26,"description":27,"timeFrame":24},"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.",null,{"allocation":28,"interventionModel":28,"interventionModelDescription":28,"primaryPurpose":28,"observationalModel":30,"timePerspective":31,"maskingInfo":28},"COHORT","PROSPECTIVE","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.",[34],{"label":35,"type":28,"description":36,"interventionNames":28},"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.",[38],{"name":39,"affiliation":5,"role":40},"Wei Phin Tan","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},"Majlinda Tafa","CONTACT","(646) 825-6338","Majlinda.Tafa@nyulangone.org",{"name":48,"role":44,"phone":49,"phoneExt":28,"email":50},"Wei Phin Tan, MD","(646) 825-6325","weiphin.tan@nyulangone.org",[52],{"facility":5,"status":53,"city":54,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":28},"RECRUITING","New York","10016","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-74.00597,40.71427,{"lat":62,"lon":61},{"type":65,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100607162","prism-study-prostate-recurrence-detection-using-imaging-with-psma-petmri-post-high-intensity-focused-ultrasound-100607162",false,"NCT07184970","PRISM Study: Prostate Recurrence Detection Using Imaging With PSMA PET\u002FMRI Post-high Intensity Focused Ultrasound","Prostate Recurrence Detection Using Imaging With PSMA PET\u002FMRI Post-high Intensity Focused Ultrasound","Inclusion Criteria:\n\n* Male patients 40-95 years of age with biopsy-confirmed localized prostate cancer.\n* Grade Group ≥2 (Gleason score 3+4 or higher).\n* Unifocal disease visible on mpMRI.\n* Patients undergoing HIFU as part of their standard of care\n* PSA \\\u003C20 ng\u002FmL.\n* No metastatic disease on PSMA PET\u002FCT\n* Willingness to comply with follow-up protocols (PSA testing, imaging, biopsies).\n\nExclusion Criteria:\n\n* Evidence of metastatic disease on PSMA PET\u002FCT.\n* Allergy to POSLUMA or gadolinium.\n* Inability to tolerate MRI due to claustrophobia or posture\u002Fback-hip issues.","MALE","40 Years","95 Years",{"count":77,"type":78},60,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to compare the sensitivity of PSMA PET\u002FMRI 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\u002FMRI offers a higher sensitivity than MRI alone for identifying recurrence or failure in patients undergoing focal therapy.",[82],"Prostate Cancer","2026-08-26",{"date":85,"type":86},"2026-08-27","ACTUAL",{"date":88,"type":86},"2025-10-08",{"date":90,"type":78},"2028-10-01",{"name":5,"class":6},1]