[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457794":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":15,"centralContacts":25,"locations":35,"responsibleParty":68,"collaborators":7,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":7,"enrollmentInfo":80,"targetDuration":83,"studyType":84,"phases":7,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":38,"whyStopped":7,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Urological Research Network, LLC","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DEVICE","Image Fusion (MR\u002FUS) Software Registration Guided Laser Ablation of Prostate Cancer","Subjects diagnosed by a transperineal fusion or random transperineal or random transrectal prostate biopsy. Laser treatment plan generated by biopsy results +\u002F- MRI is uploaded into the device. In procedure suite, a transperineal anesthetic block is conducted following by Bianco - USPTO PCT\u002FUS18\u002F24404. On lithotomy a transrectal ultrasound probe is advanced, the prostate scanned. The images are acquired by fusion device. Co-registration is performed by surgeon delimiting boundaries of prostate. Medical device delivers real-time fusion guidance outlining prostate contours, ablation goals and laser introduce location. Surgeon executes plan or adjust as needed. Surgeon activates laser device, performs ablation monitored by medical device in real-time. The fusion device will deliver great perspective between the ablation areas and critical anatomical landmarks such as: NVB, membranous urethra, etc. Patient is dismissed to the recovery room and discharged afterwards",[14],"Intervention of Interest: Prostate Cancer Laser Ablation",[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},[51,52,53,56,58,60,62,64,66],{"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",{"name":61,"role":55,"phone":7,"phoneExt":7,"email":7},"ALBERTO LOPEZ-PRIETO, MD",{"name":63,"role":55,"phone":7,"phoneExt":7,"email":7},"DAYRON RODRIGUEZ, MD",{"name":65,"role":55,"phone":7,"phoneExt":7,"email":7},"JUAN I MARTINEZ-SALAMANCA, MD",{"name":67,"role":55,"phone":7,"phoneExt":7,"email":7},"SIMON PAZ, MD",{"type":69,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100457794","mriultrasound-fusion-guided-laser-ablation-of-prostate-cancer-100457794",false,"NCT05241236","MRI\u002FUltrasound Fusion Guided Laser Ablation of Prostate Cancer","Office Based MRI\u002FUltrasound Guided Prostate Cancer Ablation: Outcomes Registry","MRFLA","Inclusion Criteria:\n\n* Men between 50 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","50 Years",{"count":81,"type":82},5000,"ESTIMATED","10 Years","OBSERVATIONAL","This serves as a registration trial. It aims to record short, intermediate, and long-term outcomes of patients treated with targeted laser ablation of biopsy confirmed prostate cancer. Outcomes will be categorized as: 1- Procedure Related, 2- Perioperative - Adverse Events that may occur within 90 days, 3-Oncologic: Recurrence of cancer in treatment area, de-novo tumors, conversion to radical surgery, radiation or cryoablation, emergence of metastasis, 4- Functional: Sexual and Urinary function following treatment",[87,88],"Neoplasms Prostate","Cancer of the Prostate",[90,91,92,93,94,95,96,97,98,99,100,101],"Prostate","PSA","FUSION","Ultrasound","MRI","Cancer","Laser","Outcomes","Recurrence","QOL, Quality of Life","Urinary function","Sexual Function","2023-01-24",{"date":104,"type":105},"2023-01-26","ACTUAL",{"date":107,"type":105},"2020-11-15",{"date":109,"type":82},"2038-11",{"name":5,"class":6},1]