[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647530":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":40,"responsibleParty":57,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Ankara Etlik City Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transrectal Cognitive Fusion Prostate Biopsy","ACTIVE_COMPARATOR","Participants randomized to this arm will undergo transrectal cognitive fusion targeted prostate biopsy combined with systematic prostate biopsy according to the institutional protocol.",[13],"Procedure: Transrectal Cognitive Fusion Prostate Biopsy",{"label":15,"type":16,"description":17,"interventionNames":18},"Transperineal Cognitive Fusion Prostate Biopsy","EXPERIMENTAL","Participants randomized to this arm will undergo transperineal cognitive fusion targeted prostate biopsy combined with systematic prostate biopsy according to the institutional protocol.",[19],"Procedure: Transperineal Cognitive Fusion Prostate Biopsy",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Cognitive fusion targeted prostate biopsy performed through the transrectal approach using multiparametric MRI findings for lesion targeting, combined with systematic prostate biopsy.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Cognitive fusion targeted prostate biopsy performed through the transperineal approach using multiparametric MRI findings for lesion targeting, combined with systematic prostate biopsy.",[15],[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"MUHAMMED Y AYDIN, Doctor","CONTACT","+90 554 838 4510","+90","mysfa63@gmail.com",{"name":37,"role":32,"phone":38,"phoneExt":25,"email":39},"ALPER G GÖK, PROFESSOR DOCTOR","+90 532 603 1181","alper_gok@hotmail.com",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":25,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Ankara","Yenimahalle","06170","Turkey (Türkiye)",{"type":48,"coordinates":49},"Point",[50,51],32.85427,39.91987,{"lat":51,"lon":50},[54],{"name":55,"role":32,"phone":56,"phoneExt":25,"email":39},"ALPER GOK, Proffessor Doctor","+90 532 603 11 81",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Muhammed Yusuf Aydın","DOCTOR","100647530","transperineal-versus-transrectal-cognitive-fusion-prostate-biopsy-100647530",false,"NCT07710807","Transperineal Versus Transrectal Cognitive Fusion Prostate Biopsy","Comparison of Transperineal and Transrectal Cognitive Fusion Prostate Biopsy for the Detection of Clinically Significant Prostate Cancer in Patients With mpMRI-Detected Suspicious Lesions: A Prospective Randomized Controlled Trial","PROCOG","Inclusion Criteria:\n\n* Male patients aged 50-75 years.\n* Patients with PI-RADS 3, 4, or 5 lesions detected on multiparametric prostate magnetic resonance imaging (mpMRI).\n* Patients with an indication for prostate biopsy.\n* Patients who are willing to participate and provide informed consent.\n\nExclusion Criteria:\n\n* Previous diagnosis of prostate cancer.\n* Active urinary tract infection.\n* Coagulopathy or bleeding disorders preventing prostate biopsy.\n* Absence of multiparametric prostate MRI evaluation.\n* No indication for prostate biopsy.","MALE","50 Years","75 Years",{"count":73,"type":74},280,"ESTIMATED","INTERVENTIONAL",[77],"NA","This prospective randomized controlled trial aims to compare transperineal and transrectal cognitive fusion prostate biopsy techniques in patients with suspicious prostate lesions detected by multiparametric magnetic resonance imaging (mpMRI).\n\nPatients aged 50-75 years with PI-RADS 3-5 lesions on mpMRI and an indication for prostate biopsy will be randomly assigned in a 1:1 ratio to undergo either transperineal cognitive fusion prostate biopsy or transrectal cognitive fusion prostate biopsy.\n\nThe primary objective of this study is to evaluate whether transperineal cognitive fusion biopsy is non-inferior to transrectal cognitive fusion biopsy in detecting clinically significant prostate cancer (csPCa). Secondary objectives include comparison of overall prostate cancer detection rates, detection of Gleason Grade Group ≥2 prostate cancer, biopsy-related infectious complications, other procedure-related complications, pain scores, and procedure duration.\n\nA total of 280 participants will be enrolled. Pathological evaluation will be performed after biopsy, and clinical outcomes and complications will be assessed during follow-up.",[80,81,82],"Prostate Cancer","Clinically Significant Prostate Cancer","Cognitive Fusion",[84,85,86,87,88],"prostate biopsy","Transperineal biopsy","Transrectal biopsy","Multiparametric magnetic resonance imaging","Prostate cancer detection","2026-07-14",{"date":91,"type":92},"2026-07-17","ACTUAL",{"date":94,"type":92},"2026-06-01",{"date":96,"type":74},"2027-03-31",{"name":5,"class":6},1]