[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605906":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":17,"locations":26,"responsibleParty":175,"collaborators":178,"id":197,"slug":198,"hasResults":199,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":199,"sex":205,"minAge":206,"maxAge":7,"enrollmentInfo":207,"targetDuration":210,"studyType":211,"phases":7,"briefSummary":212,"conditions":213,"keywords":216,"overallStatus":29,"whyStopped":7,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},{"fullName":5,"class":6},"Istanbul University - Cerrahpasa","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","Ga-68 PSMA11 PET\u002FCT","delayed (120-minute) Ga-68 PSMA PET\u002FCT and will be evaluated by using Istanbul PSMA PET\u002FCT Criteria (IPPC)",[14],{"name":15,"affiliation":5,"role":16},"Levent Kabasakal, Prof. MD","PRINCIPAL_INVESTIGATOR",[18,22],{"name":15,"role":19,"phone":20,"phoneExt":7,"email":21},"CONTACT","00905323667908","lkabasakal@tsnm.org",{"name":23,"role":19,"phone":24,"phoneExt":7,"email":25},"Nalan Alan, Prof. MD.","00905322940667","nalanselcuk@yahoo.com",[27,51,66,79,96,106,122,138,151,165],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":7,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Yeditepe University","RECRUITING","Istanbul","Turkey","34000","Turkey (Türkiye)",{"type":35,"coordinates":36},"Point",[37,38],28.94966,41.01384,{"lat":38,"lon":37},[41,42,46,49],{"name":23,"role":19,"phone":24,"phoneExt":7,"email":25},{"name":43,"role":19,"phone":44,"phoneExt":7,"email":45},"Kaan Akcay, Resident, MD","00905079195680","Kaan.akcay@yeditepe.edu.tr",{"name":47,"role":48,"phone":7,"phoneExt":7,"email":7},"Gamze Beydagi, Resident, MD","SUB_INVESTIGATOR",{"name":50,"role":48,"phone":7,"phoneExt":7,"email":7},"Turkay Toklu, Phys. 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Prof. MD.","00905557041806","onur.sahin@iuc.edu.tr",{"name":15,"role":16,"phone":7,"phoneExt":7,"email":7},{"facility":152,"status":29,"city":30,"state":7,"zip":32,"country":33,"countryCode":7,"cosmosGeoPoint":153,"geoPoint":155,"contacts":156},"SBÜ Başakşehir Çam Sakura Şehir hastanesi",{"type":35,"coordinates":154},[37,38],{"lat":38,"lon":37},[157,161],{"name":158,"role":19,"phone":159,"phoneExt":7,"email":160},"Burcu Esen Akkaş, Prof. MD.","00905327450364","burcuesen@yahoo.com",{"name":162,"role":19,"phone":163,"phoneExt":7,"email":164},"Halil Lütfi Canat, Prof. MD.","00905056884234","drclcanat@gmail.com",{"facility":166,"status":29,"city":30,"state":7,"zip":32,"country":33,"countryCode":7,"cosmosGeoPoint":167,"geoPoint":169,"contacts":170},"Sisli Hamidiye Etfal Eğitim ve Arastırma Hastanesi",{"type":35,"coordinates":168},[37,38],{"lat":38,"lon":37},[171],{"name":172,"role":19,"phone":173,"phoneExt":7,"email":174},"Nurettin Cem Sonmez, Prof. MD.","00905324259128","ncsonmez@hotmail.com",{"type":16,"investigatorFullName":176,"investigatorTitle":177,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Levent Kabasakal","Professor of Nuclear Medicine, Medical Doctor",[179,180,182,184,186,188,191,193,195],{"name":28,"class":6},{"name":181,"class":6},"Yedikule Training and Research Hospital",{"name":183,"class":6},"Acibadem University",{"name":185,"class":6},"Ankara Yildirim Beyazıt University",{"name":187,"class":6},"University of Gaziantep",{"name":189,"class":190},"Istanbul Training and Research Hospital","OTHER_GOV",{"name":192,"class":6},"Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital",{"name":194,"class":6},"Sisli Hamidiye Etfal Training and Research Hospital",{"name":196,"class":6},"Haseki Training and Research Hospital","100605906","study-of-psma-petct-imaging-to-help-select-men-with-low-risk-prostate-cancer-for-active-surveillance-100605906",false,"NCT07168616","Study of PSMA PET\u002FCT Imaging to Help Select Men With Low-Risk Prostate Cancer for Active Surveillance","Prospective Evaluation of Istanbul PSMA PET\u002FCT Criteria for Selecting Candidates for Active Surveillance in Low-Risk Prostate Cancer","I-SELECT","Inclusion Criteria:\n\n* mpMRI performed within 3 months prior to enrollment\n* Systematic or MRI-targeted prostate biopsy performed\n* Biopsy-confirmed ISUP Grade 1 low-risk PCa\n* Prostate biopsy report specifying tumor localization and number of positive cores\n* Meets AS criteria: ISUP 1, PSA ≤10 ng\u002FmL, PSAd \\>0.15 ng\u002FmL², clinical stage cT1c-T2a, ≤3 positive cores\n* Life expectancy ≥10 years\n* No prior PSMA PET imaging\n* No evidence of extra-prostatic disease on mpMRI\n* Signed informed consent for study procedures\n\nExclusion Criteria:\n\n* High-risk or unfavorable intermediate-risk PCa, or adverse histologies (neuroendocrine, ductal adenocarcinoma, basal cell carcinoma, TP53 or BRCA1\u002F2 mutations if available)\n* Prior prostate cancer treatment or prostate surgery\n* MRI evidence of extracapsular extension, seminal vesicle invasion, or nodal metastasis\n* History of pelvic radiotherapy\n* Life expectancy \\\u003C10 years\n* Severe renal impairment\n* Inability to comply with follow-up schedule","MALE","18 Years",{"count":208,"type":209},201,"ESTIMATED","2 Years","OBSERVATIONAL","This is a multicenter, prospective diagnostic accuracy study evaluating the Istanbul PSMA PET\u002FCT Criteria (IPPC) for selecting patients with biopsy-confirmed low-risk prostate cancer (ISUP Grade 1) for active surveillance (AS). The study integrates delayed Ga-68 PSMA PET\u002FCT imaging into the diagnostic pathway to refine patient stratification, minimize overtreatment and potentially reduce unnecessary biopsies and MRI, or exposing high-risk individuals to the danger of cancer progression if left untreated scans.",[214,215],"Low Risk Prostate Cancer","Clinically Significant Prostate Cancer",[217,218,219,220,221,222],"PSMA PET\u002FCT","Low risk prostate cancer","active surveillance","prostate cancer","clinically significant prostate cancer","Diagnosis of prostate cancer","2025-09-11",{"date":225,"type":226},"2025-09-15","ACTUAL",{"date":228,"type":226},"2025-09-01",{"date":230,"type":209},"2028-06-01",{"name":5,"class":6},10]