[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642806":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":19,"collaborators":11,"id":21,"slug":22,"hasResults":23,"nctId":24,"briefTitle":25,"officialTitle":26,"acronym":11,"eligibilityCriteria":27,"healthyVolunteers":23,"sex":28,"minAge":29,"maxAge":11,"enrollmentInfo":30,"targetDuration":11,"studyType":33,"phases":34,"briefSummary":36,"conditions":37,"keywords":11,"overallStatus":39,"whyStopped":11,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":11},{"fullName":5,"class":6},"Norroy Bioscience Co., LTD","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"68-Ga-NYM032","EXPERIMENTAL",null,[13],"Diagnostic Test: 68-Ga-NYM032",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DIAGNOSTIC_TEST","IV injection",[9],{"type":20,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100642806","phase-3-this-study-evaluates-the-diagnostic-performance-and-safety-of-68ga-nym032-petct-imaging-in-patients-with-suspected-recurrence-of-prostate-cancer-100642806",false,"NCT07649122","This Study Evaluates the Diagnostic Performance and Safety of 68Ga-NYM032 PET\u002FCT Imaging in Patients With Suspected Recurrence of Prostate Cancer.","A Phase 3, Multi-Center, Open-Label Study to Assess the Diagnostic Performance and Safety of 68Ga-NYM032 Injection PET\u002FCT Imaging Results in Men With Suspected Recurrence of Prostate Cancer","Inclusion Criteria:\n\n1. Patient is male and aged \\>18 years old.\n2. Participants with histopathologically confirmed prostate adenocarcinoma, who present with elevated PSA and suspected recurrence following radical prostatectomy and\u002For radiotherapy and\u002For other radical prostate cancer treatments (e.g., proton therapy, cryoablation, high-intensity focused ultrasound, etc.). (PSA must be measured within 30 days prior to screening.). (Meeting any one of the following criteria):\n\n   1. Post-radical prostatectomy (RP): PSA ≥0.2 ng\u002FmL on two consecutive measurements obtained ≥6 weeks after surgery;\n   2. Post-radiotherapy (as defined by the ASTRO-Phoenix consensus): PSA rise ≥2 ng\u002FmL above the PSA nadir;\n   3. Participants with recurrence after other treatments: PSA rise ≥2 ng\u002FmL above the PSA nadir.\n3. ECOG performance status 0-2; expected survival ≥ 6 months.\n4. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Participants who have previously participated in other interventional clinical trials and are within five physical half-lives, or have received radionuclide agents previously with an interval of less than ten physical half-lives prior to study drug injection.\n2. Participants administered any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection.\n3. Known hypersensitivity to the active ingredient or excipients of the study drug.\n4. Participants not capable of getting PET study , or inability to lay still for the duration of the exam.\n5. Any medical condition or circumstance that, in the investigator's judgment, may compromise study safety or patient compliance.","MALE","18 Years",{"count":31,"type":32},232,"ESTIMATED","INTERVENTIONAL",[35],"PHASE3","This study evaluates the diagnostic performance and safety of 68Ga-NYM032 PET\u002FCT imaging in patients with suspected recurrence of prostate cancer.",[38],"Prostate Cancer","NOT_YET_RECRUITING","2026-06-11",{"date":42,"type":43},"2026-06-16","ACTUAL",{"date":45,"type":32},"2026-06-30",{"date":47,"type":32},"2028-07-31",{"name":5,"class":6}]