[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553173":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":39,"responsibleParty":58,"collaborators":61,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":25,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":25,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TB+PB group","EXPERIMENTAL","For each predefined MRI suspicious lesion, TB cores were obtained within each predefined MRI suspicious lesion (region of interest, ROI), followed by ring-distributed PB cores within a 10-15 mm radius around the ROI. The location of these cores depended on the shape and location of the suspicious lesion.",[13],"Procedure: TB+PB",{"label":15,"type":10,"description":16,"interventionNames":17},"TB+SB group","For patients in the TB+SB group, TB cores were obtained from the lesion, followed by 12-core SB.",[18],"Procedure: TB+SB",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","TB+PB","The biopsy procedure was conducted by highly skilled and experienced urologists who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. For each predefined MRI suspicious lesion, TB cores were obtained within each predefined MRI suspicious lesion (region of interest, ROI), followed by ring-distributed PB cores within a 10-15 mm radius around the ROI. The location of these cores depended on the shape and location of the suspicious lesion.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"TB+SB","The biopsy procedure was conducted by highly skilled and experienced urologists who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. TB cores were obtained from the lesion, followed by 12-core SB.",[15],[31],{"name":32,"affiliation":5,"role":33},"Yi LIU","PRINCIPAL_INVESTIGATOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+86 13611035261","liuyipkuhsc@163.com",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Beijing","Beijing Municipality","100034","China","CN",{"type":48,"coordinates":49},"Point",[50,51],116.39723,39.9075,{"lat":51,"lon":50},[54],{"name":55,"role":36,"phone":56,"phoneExt":25,"email":57},"Baowei Zhang","+86 83572466","bdyyll@126.com",{"type":33,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"LIU Yi","Associate chief physician",[62,65,67,69,72,74,76],{"name":63,"class":64},"Beijing Hospital","OTHER_GOV",{"name":66,"class":6},"Shanghai East Hospital",{"name":68,"class":6},"Beijing Friendship Hospital",{"name":70,"class":71},"Chinese People's Liberation Army (PLA) General Hospital","UNKNOWN",{"name":73,"class":6},"Zhejiang Cancer Hospital",{"name":75,"class":6},"First Affiliated Hospital of Chongqing Medical University",{"name":77,"class":6},"Tianjin Medical University Cancer Institute and Hospital","100553173","evaluation-of-perilesional-biopsy-in-diagnosis-of-prostate-cancer-100553173",false,"NCT06482645","Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer","Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer: a Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* The age of the patient is between 45 and 85.\n* No previous biopsy.\n* Patients with single suspicious lesion, complete MRI data, qualified image quality control, suspicious lesions, and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of \\> 3.\n* Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) \\>10ng\u002FmL, tPSA 4-10ng\u002FmL with free-to-total PSA ratio (f\u002FtPSA) \\\u003C0.16 or PSA density (PSAD) \\>0.15.\n* The prostate biopsy pathological results were complete. The time interval between prostate biopsy and prostate MRI examination should not exceed one month.\n* Patients with complete clinical information.\n\nExclusion Criteria:\n\n* The MRI data was unqualified or incomplete.\n* Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate MRI examination or prostate biopsy.\n* Patients with previous biopsy.\n* Patients with PI-RADS V2.1 of \\\u003C 4.\n* Patients were not in accordance with the indication of prostate biopsy.\n* The patient could not cooperate to complete the prostate biopsy.\n* The patients or their family members refused to participate in this study.\n* Patients with incomplete clinical information.","MALE","45 Years","85 Years",{"count":89,"type":90},640,"ESTIMATED","INTERVENTIONAL",[93],"NA","The goal of this multicenter randomized controlled trial (RCT) is to evaluate the efficacy of different prostate biopsy schemes, including perilesional biopsy (PB) and combination of systematic biopsy and targeted biopsy (TB+SB).\n\nThe main questions it aims to answer are:\n\nDoes PB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of PB and TB+SB to explore the efficacy of different prostate biopsy schemes.\n\nParticipants will:\n\nReceive TB+PB or TB+SB.",[96],"Prostate Cancer",[98,99,100],"Prostate cancer","Multicenter randomized controlled trial","Perilesional biopsy","2026-06-09",{"date":103,"type":104},"2026-06-11","ACTUAL",{"date":106,"type":104},"2024-07-01",{"date":108,"type":90},"2026-12-31",{"name":5,"class":6},1]