[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555885":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":42,"responsibleParty":120,"collaborators":26,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":124,"sex":130,"minAge":131,"maxAge":26,"enrollmentInfo":132,"targetDuration":26,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Albany Medical College","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Software fusion biopsy","ACTIVE_COMPARATOR","Software fusion biopsy: Biopsy of the MRI-detected lesion using an image fusion platform such as UroNav or similar.",[13],"Procedure: Software fusion prostate biopsy",{"label":15,"type":16,"description":17,"interventionNames":18},"Cognitive fusion biopy","EXPERIMENTAL","Cognitive fusion biopsy: Biopsy of the MRI-detected lesion using visual estimation and\u002For measurements to identify landmarks and lesions.",[19],"Procedure: Cognitive fusion prostate biopsy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Software fusion prostate biopsy","Software fusion biopsy: Each participant in this study arm will first undergo biopsy of the MRI-detected lesion using an image fusion platform such as UroNav or similar. Three biopsy cores will be taken per lesion, with a maximum of three lesions being sampled per participant. Then systematic samples will be taken from the remainder of the prostate as per standard protocol (10-12 cores).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Cognitive fusion prostate biopsy","Cognitive fusion biopsy: Each participant in this study arm will first undergo biopsy of the MRI-detected lesion using visual estimation and\u002For measurements of lesion. Three biopsy cores will be taken per lesion, with a maximum of three lesions being sampled per participant. Then systematic samples will be taken from the remainder of the prostate as per standard protocol (10-12 cores).",[15],[32],"Visual estimation fusion prostate biopsy",[34],{"name":35,"affiliation":5,"role":36},"Badar M Mian, MD","STUDY_CHAIR",[38],{"name":35,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","5182623296","mianb@amc.edu",[43,65,83,101],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Lahey Clinic, Inc","RECRUITING","Burlington","Massachusetts","01805","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-71.19561,42.50482,{"lat":55,"lon":54},[58,62],{"name":59,"role":39,"phone":60,"phoneExt":26,"email":61},"Kimberly Rieger-Christ","781-744-8027","bilh_osr@lahey.org",{"name":63,"role":64,"phone":26,"phoneExt":26,"email":26},"William Faust, MD","PRINCIPAL_INVESTIGATOR",{"facility":66,"status":45,"city":67,"state":68,"zip":69,"country":49,"countryCode":50,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Albany Medical Center","Albany","New York","12208",{"type":52,"coordinates":71},[72,73],-73.75623,42.65258,{"lat":73,"lon":72},[76,79],{"name":77,"role":39,"phone":78,"phoneExt":26,"email":41},"Badar M. Mian, MD","518-262-7558",{"name":80,"role":39,"phone":81,"phoneExt":26,"email":82},"Brenda Romeo","518-262-8579","romeob@amc.edu",{"facility":84,"status":85,"city":86,"state":87,"zip":88,"country":49,"countryCode":50,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Pennsylvania State University","NOT_YET_RECRUITING","Hershey","Pennsylvania","17023",{"type":52,"coordinates":90},[91,92],-76.65025,40.28592,{"lat":92,"lon":91},[95,99],{"name":96,"role":39,"phone":97,"phoneExt":26,"email":98},"Suzanne Boltz","717-531-0003","urologyresearch@pennstatehealth.psu.edu",{"name":100,"role":64,"phone":26,"phoneExt":26,"email":26},"Jay Raman, MD",{"facility":102,"status":85,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Manitoba Prostate Centre, CancerCare Manitoba","Winnipeg","Manitoba","R3A 1M5","Canada","CA",{"type":52,"coordinates":109},[110,111],-97.14704,49.8844,{"lat":111,"lon":110},[114,118],{"name":115,"role":39,"phone":116,"phoneExt":26,"email":117},"Zoe Ignation","204-787-2955","zignacio@cancercare.mb.ca",{"name":119,"role":64,"phone":26,"phoneExt":26,"email":26},"Ardalanejaz Ahmad, MD",{"type":121,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100555885","fusion-or-cognitive-ultrasound-guided-biopsy-to-detect-prostate-cancer-100555885",false,"NCT06517901","Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer","MRI-targeted Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer","FOCUS-PC","Inclusion Criteria:\n\n* Men undergoing prostate biopsy (either transrectal or transperineal) for suspected prostate cancer as part of their regular medical care\n* Must be eligible to undergo both prostate biopsy procedure (cognitive or fusion)\n* Men undergoing their first prostate biopsy procedure or with no previous prostate biopsy within 3 years\n* Pre-biopsy mp-MRI of prostate with one or more lesions classified as PIRADS 3-5\n* Largest dimension of any lesion on mp-MRI to be ≤ 2 cm\n* Prostate-specific antigen level ≤ 20 ng\u002FmL and\u002For abnormal digital rectal examination\n\nExclusion Criteria:\n\n* mp-MRI detected lesions that are \\> 2 cm\n* History of prostate biopsy within 3 years\n* Previous diagnosis of prostate cancer\n* Contraindications to prostate biopsy (eg, fever, evidence of genito-urinary infection, excessive co-morbidities as per treating physician)","MALE","18 Years",{"count":133,"type":134},1306,"ESTIMATED","INTERVENTIONAL",[137],"NA","The MRI-targeted biopsy for prostate cancer detection can be performed using one of two techniques:\n\n1. Software-based fusion of MRI and ultrasound images (software fusion) or\n2. Visually estimated MRI-informed (cognitive fusion) technique\n\nTo date, there is a lack of adequately powered RCTs directly comparing the cognitive vs fusion targeted biopsy. This randomized study will directly compare the detection rates of clinically significant prostate cancer following either the cognitive or the fusion targeted prostate biopsy in men with suspicious lesions noted on multi-parametric MRI (mp-MRI) of prostate.",[140,141],"Prostate Cancer","Diagnosis",[143,144,145,141,146],"Prostate","Cancer","Biopsy","MRI","2025-09-30",{"date":149,"type":150},"2025-10-03","ACTUAL",{"date":152,"type":150},"2025-04-18",{"date":154,"type":134},"2027-06-30",{"name":5,"class":6},4]