[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100238430":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":15,"centralContacts":25,"locations":35,"responsibleParty":60,"collaborators":7,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":7,"enrollmentInfo":72,"targetDuration":75,"studyType":76,"phases":7,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":38,"whyStopped":7,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Urological Research Network, LLC","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"PROCEDURE","FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY","Biopsy proven Prostate Cancer is delimited and defined by MP-MRI. The MRI study is fused with transrectal ultrasound in realtime. The cryogenic \"cryoprobes\u002Fdevices\" are employed to freeze and all \"circuled or noted\" cancer lesions. Two freeze 8 min\u002F thaw 10 min clycles are performed. Thermocouples are used to monitor treatment areas and safety margins",[14],"Intervention of Interest: Prostate Cryoablation",[16,20,23],{"name":17,"affiliation":18,"role":19},"FERNANDO J BIANCO, MD","UROLOGICAL RESEARCH NETWORK","PRINCIPAL_INVESTIGATOR",{"name":21,"affiliation":18,"role":22},"EUSEBIO LUNA, MD","STUDY_DIRECTOR",{"name":24,"affiliation":18,"role":22},"Isabel H Lopez, MD",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":7,"email":30},"CIELO D GUERRA, BS","CONTACT","305-515-9887","CIELO@BESTUROLOGY.NET",{"name":32,"role":28,"phone":33,"phoneExt":7,"email":34},"LUANDA SIANO, PA","305-822-7227","LUANDA@BESTUROLOGY.NET",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Urological Research Network","RECRUITING","Miami Lakes","Florida","33016","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-80.30866,25.90871,{"lat":48,"lon":47},[51,52,53,56,58],{"name":27,"role":28,"phone":29,"phoneExt":7,"email":30},{"name":17,"role":19,"phone":7,"phoneExt":7,"email":7},{"name":54,"role":55,"phone":7,"phoneExt":7,"email":7},"EDWARD L GHEILER, MD","SUB_INVESTIGATOR",{"name":57,"role":55,"phone":7,"phoneExt":7,"email":7},"ARIEL M KAUFMAN, MD",{"name":59,"role":55,"phone":7,"phoneExt":7,"email":7},"EUSEBIO J LUNA, MD",{"type":61,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100238430","mriultrasound-fusion-guided-prostate-cryotherapy-100238430",false,"NCT02381990","MRI\u002FUltrasound Fusion Guided Prostate Cryotherapy","Office Based MRI\u002FUltrasound Guided Prostate Cryotherapy: Outcomes Registry","FIPC","Inclusion Criteria:\n\n* Men between 55 and 65 years of age with a clinical diagnosis of prostate cancer with Low or Intermediate risk prostate cancer, and \\\u003C50% positive core rate by prostate lobe\n* Men older than 65 years of age with clinical diagnosis of prostate cancer \\\u003C50% positive core rate by prostate lobe\n* Absence of extra-capsular extension\n* Absence of seminal vesicle invasion\n* Absence of regional or distant metastatic disease\n* Multiparametric MRI of the prostate performed either before the biopsy or \\>10 weeks after prostate biopsy\n* Treated with Cryotherapy of the prostate\n* Treatment based on co-registration between MP-MRI and Prostate Ultrasound\n\nExclusion Criteria:\n\n* Prior treatment of prostate cancer in the form of surgery.\n* Performance status greater than 0 based on ECOG criteria\n* Mental status impairment","MALE","55 Years",{"count":73,"type":74},5000,"ESTIMATED","10 Years","OBSERVATIONAL","Registration of Prostate Cancer patients undergoing Prostate Cryotherapy guided by Mutiparametric-MRI (MP-MRI) highlighting biopsy confirmed regions. The primary outcome measure is 5 year oncological control. Secondary aim is lack of progression beyond the prostate gland. The aim of intervention is to eradicate prostate cancer disease in the treated area while imposing no or minimal deleterious effects in quality of life.",[79,80],"Neoplasms Prostate","Cancer of the Prostate",[82,83,84,85,86,87,88,89,90,91,92,93],"Prostate","PSA","FUSION","Ultrasound","MRI","Cancer","Cryotherapy","Outcomes","Recurrence","QOL, Quality of Life","Urinary function","Sexual Function","2023-01-24",{"date":96,"type":97},"2023-01-26","ACTUAL",{"date":99,"type":97},"2013-08",{"date":101,"type":74},"2033-08",{"name":5,"class":6},1]