[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616525":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":36,"studyPopulation":29,"armGroups":37,"interventions":44,"overallOfficials":29,"centralContacts":52,"locations":58,"responsibleParty":78,"collaborators":29,"id":82,"slug":29,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":29,"maxAge":29,"enrollmentInfo":90,"targetDuration":29,"studyType":93,"phases":94,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":74,"whyStopped":29,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Menoufia University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":29},[9,13],{"measure":10,"description":11,"timeFrame":12},"Prostate Cancer Detection Rate Assessed by Histopathological Examination","Detection of prostate cancer based on histopathological examination of biopsy core specimens obtained using cognitive-targeted biopsy and fusion-targeted biopsy. This outcome is reported as the presence or absence of prostate cancer and is not reported as a numerical score on a scale.","During the biopsy session",{"measure":14,"description":15,"timeFrame":12},"Clinically Significant Prostate Cancer Detection Rate Defined by International Society of Urological Pathology Grade Group","Detection of clinically significant prostate cancer based on histopathological evaluation of biopsy specimens obtained using each biopsy technique. Clinically significant prostate cancer is defined using the International Society of Urological Pathology (ISUP) Grade Group classification, which ranges from Grade Group 1 (least aggressive) to Grade Group 5 (most aggressive). Clinically significant disease is defined as ISUP Grade Group 2 or higher. Higher ISUP grade groups indicate a worse pathological outcome.",[17,21,25],{"measure":18,"description":19,"timeFrame":20},"Biopsy Procedure Time Measured in Minutes","Duration of each biopsy technique, measured in minutes from insertion of the ultrasound probe to completion of tissue sampling for cognitive-targeted biopsy and fusion-targeted biopsy. This outcome is a direct time measurement and not a scale-based score.","During the procedure",{"measure":22,"description":23,"timeFrame":24},"Target Lesion Length Measured on Multiparametric Magnetic Resonance Imaging","Maximum lesion length measured in millimeters on pre-biopsy multiparametric magnetic resonance imaging. This outcome is a direct physical measurement and not a score on a scale.","Before the biopsy procedure",{"measure":26,"description":27,"timeFrame":28},"Procedural Metrics According to Surgeon Assignment","Assessment of procedural parameters, including procedure duration, according to surgeon assignment. These outcomes are not reported as scale-based scores.","During the biopsy procedure",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"NA","SEQUENTIAL","DIAGNOSTIC",{"masking":35,"maskingDescription":29,"whoMasked":29},"NONE","This study will be conducted in the urology department, Menoufia University, and will include biopsy-naïve patients with clinical suspicion of prostate cancer. Suspicion will be based on abnormal digital rectal examination (DRE) findings and prostate-specific antigen (PSA) levels between 4 and 20 nanograms per milliliter (ng\u002FmL).\n\nAll eligible patients will undergo multiparametric magnetic resonance imaging (mpMRI) of the prostate using a 1.5-Tesla scanner. Imaging will be interpreted by a single experienced radiologist. Only patients with lesions scored as Prostate Imaging-Reporting and Data System (PI-RADS) category 4 or 5 will be included in the study.\n\nParticipants who meet the inclusion criteria will undergo both cognitive-targeted biopsy (CTB) and magnetic resonance imaging-ultrasound fusion-targeted biopsy (FTB) during the same biopsy session. Biopsies will be performed under local or regional anesthesia using the BK3000 ultrasound system.\n\nThe study will assess predefined procedural and pathological parameters, including histopathological findings (presence or absence of malignancy and International Society of Urological Pathology \\[ISUP\\] grade group), lesion location by prostate zone and orientation, serum prostate-specific antigen and prostate-specific antigen density, lesion length, and procedure duration. Procedures will be performed by two operators (surgeon 1 and surgeon 2) according to the study protocol.\n\nNo results are reported in this section. Study outcomes will be entered in the results section after study completion.",[38],{"label":39,"type":40,"description":41,"interventionNames":42},"Sequential cognitive-targeted biopsy followed by fusion-targeted biopsy","EXPERIMENTAL","Participants will undergo a cognitive-targeted prostate biopsy followed immediately by a fusion-targeted prostate biopsy during the same session. Each participant will receive both biopsy techniques sequentially, allowing within-subject comparison. Participants will be assigned to one of two surgeons using a blinded randomization process; however, all participants will receive the same intervention protocol.",[43],"Procedure: Cognitive-targeted prostate biopsy",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"PROCEDURE","Cognitive-targeted prostate biopsy","Participants will undergo a cognitive-targeted prostate biopsy followed immediately by a fusion-targeted prostate biopsy during the same session.",[39],[51],"Fusion-targeted prostate biopsy",[53],{"name":54,"role":55,"phone":56,"phoneExt":29,"email":57},"Mahmoud A Wahbah, MASTER","CONTACT","00201015684868","mwahbah4@gmail.com",[59,73],{"facility":60,"status":61,"city":62,"state":29,"zip":29,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Menoufia university hospital urology department","NOT_YET_RECRUITING","Shibīn al Kawm","Egypt","EG",{"type":66,"coordinates":67},"Point",[68,69],31.00904,30.55258,{"lat":69,"lon":68},[72],{"name":54,"role":55,"phone":56,"phoneExt":29,"email":57},{"facility":60,"status":74,"city":62,"state":29,"zip":29,"country":63,"countryCode":64,"cosmosGeoPoint":75,"geoPoint":77,"contacts":29},"RECRUITING",{"type":66,"coordinates":76},[68,69],{"lat":69,"lon":68},{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Mahmoud Ahmed Mohammed","ASSISTANT LECTURER","100616525",false,"NCT07306741","Cognitive and Fusion Prostatic Biopsy","Cognitive Versus Image Guided Fusion Transrectal Prostatic Biopsy for the Detection of Prostate Cancer","CTB-FTB","Inclusion Criteria:\n\nBiopsy-naïve patients\n\nProstate-specific antigen level between 4 and 20 ng\u002FmL\n\nMultiparametric Magnetic Resonance Imaging Prostate Imaging-Reporting and Data System score 4 or 5\n\nExclusion Criteria:\n\nPrior prostate biopsy\n\nProstate-specific Antigen level outside the specified range\n\nContraindication to Magnetic Resonance Imaging","MALE",{"count":91,"type":92},80,"ESTIMATED","INTERVENTIONAL",[31],"The goal of this study is to compare two different prostate biopsy techniques used to detect prostate cancer. These techniques are cognitive-targeted biopsy (CTB) and magnetic resonance imaging-ultrasound fusion-targeted transrectal biopsy (FTB). Both methods aim to improve the accuracy of prostate cancer detection by targeting suspicious areas identified on prostate imaging. This study will compare how accurately each technique detects prostate cancer, the pathological findings obtained from each biopsy method, and how operator performance may influence the procedure. The information gained from this study may help improve prostate cancer diagnosis and guide future biopsy practices.",[97],"Prostate Cancer",[99,100,101,102,103,104],"Cognitive-Targeted Biopsy","Magnetic Resonance Imaging-Ultrasound Fusion Biopsy","Multiparametric Magnetic Resonance Imaging","Transrectal Prostate Biopsy","Prostate Cancer Detection","Diagnostic Accuracy","2026-01-01",{"date":107,"type":108},"2026-01-05","ACTUAL",{"date":110,"type":108},"2025-12-28",{"date":112,"type":92},"2026-08-05",{"name":5,"class":6},2]