[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587074":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":56,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":26,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"First Affiliated Hospital of Fujian Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"The control group","ACTIVE_COMPARATOR","The control group will receive TRUS guided transperineal saturation biopsy.",[13],"Diagnostic Test: TRUS guided transperineal saturation biopsy",{"label":15,"type":16,"description":17,"interventionNames":18},"The experimental group","EXPERIMENTAL","The experimental group will undergo PSMA PET\u002FMRI examination. For those with positive PSMA PET\u002FMRI results, a PSMA PET\u002FMRI-TRUS guided prostate targeted biopsy will be performed based on transrectal ultrasound (TRUS) guided transperineal saturation biopsy, targeting the positive lesions. For those with negative PSMA PET\u002FMRI results, only TRUS guided transperineal saturation biopsy will be performed.",[19],"Diagnostic Test: PSMA PET\u002FMRI-TRUS guided prostate targeted combined saturation biopsy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","PSMA PET\u002FMRI-TRUS guided prostate targeted combined saturation biopsy","The experimental group will undergo PSMA PET\u002FMRI examination. For those with positive PSMA PET\u002FMRI results, a PSMA PET\u002FMRI-TRUS guided prostate targeted biopsy will be performed based on transrectal ultrasound (TRUS) guided transperineal saturation biopsy, targeting the positive lesions. For those with negative PSMA PET\u002FMRI results, only TRUS guided transperineal saturation biopsy will be performed. Clinical and pathological data of the patients will be collected for statistical analysis.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"TRUS guided transperineal saturation biopsy","The control group will receive TRUS guided transperineal saturation biopsy. Clinical and pathological data of the patients will be collected for statistical analysis.",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Ning Xu","CONTACT","13235907575","0086","drxun@fjmu.edu.cn",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"The First Affiliated Hospital of Fujian Medical University","RECRUITING","Fuzhou","Fujian","350005","China","CN",{"type":48,"coordinates":49},"Point",[50,51],119.30611,26.06139,{"lat":51,"lon":50},[54],{"name":33,"role":34,"phone":55,"phoneExt":26,"email":37},"059187981687",{"type":57,"investigatorFullName":33,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Deputy Director of Department","100587074","psma-petmri-guided-prostate-biopsy-for-pi-rads-3-and-prior-negative-biopsy-100587074",false,"NCT06923657","PSMA PET\u002FMRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy","Application of PSMA PET\u002FMRI-guided Prostate Targeted Biopsy in Patients With PI-RADS ≤ 3 and Negative Previous Biopsy: A Single-center, Prospective, Open-label, Randomized Controlled Trial","Inclusion Criteria:\n\n* Serum PSA \\> 4 ng\u002FmL\n* At least one prior negative prostate biopsy\n* At least two consecutive increases in PSA and\u002For PHI\n* Negative digital rectal examination\n* Multiparametric MRI (mpMRI) indicating a PI-RADS score ≤ 3\n\nExclusion Criteria\n\n* Age ≤ 30 years or \\> 85 years\n* Concurrent presence of other malignant tumors\n* Previous treatment with any form of anti-tumor therapy or prostate surgery (excluding prostate biopsy)\n* Inability to comply with PSMA PET\u002FMRI examination (e.g., contrast allergy, claustrophobia, etc.)\n* Contraindications for prostate biopsy (e.g., coagulation disorders, acute prostatitis, acute urinary tract infection, etc.)\n* Severe organ dysfunction (e.g., significant cardiac, pulmonary, hepatic, or renal impairment)\n* Incomplete clinical or pathological data","MALE","30 Years","85 Years",{"count":70,"type":71},230,"ESTIMATED","INTERVENTIONAL",[74],"NA","The goal is to provide more accurate diagnostic tools and optimized diagnostic workflows for clinically suspected prostate cancer patients with prior negative biopsies, improving early detection rates for csPCa and reducing missed diagnoses.",[77,78],"Prostate Cancer Screening","PSMA-PET",[80,81,82],"imaging examinations","PSMA PET\u002FMRI","Prostate cancer","2026-05-26",{"date":85,"type":86},"2026-05-28","ACTUAL",{"date":88,"type":86},"2025-05-07",{"date":90,"type":71},"2026-12-01",{"name":5,"class":6},1]