[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dongkook Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100553764","phase-3-efficacy-and-safety-of-dkf-ma102-in-patients-with-prostate-cancer-100553764",false,"NCT06490328","Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer","A Phase 3, Multi-center, Single-group, Open-label Study to Evaluate the Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer","Inclusion Criteria:\n\n1. Adult male aged 19 or older\n2. Histologically or cytologically-confirmed prostate cancer\n3. Serum testosterone level \\>150 ng\u002FdL\n4. ECOG PS grade ≤ 2\n5. Life expectancy of at least 1 year\n\nExclusion Criteria:\n\n1. History of surgical procedures such as testicular resection, adrenal resection, and pituitary resection\n2. History of hormone therapy\n3. History of 5α-reductase inhibitor\n4. History of radical radiation therapy\n5. History of adjuvant male hormone block therapy\n6. Severe liver failure\n7. Serum creatinine ≥1.5 times the ULN\n8. Hormone-independent prostate cancer\n9. Diagnosed pituitary adenoma\n10. Brain metastasis or spinal cord compression\n11. Requires prostatectomy, radiation therapy, chemotherapy, and anti-androgen therapy during the clinical trial period\n12. Urinary tract obstruction\n13. Cardiovascular disease\n14. Significant impairments in the digestive system, respiratory system, endocrine system, and central nervous system\n15. Uncontrolled diabetes\n16. Allergic reaction or hypersensitivity to any ingredient of the investigational product or to a synthetic GnRH or GnRH analogs\n17. Severe asthma, severe vascular edema, and severe hives\n18. Significant infection\n19. Lack of self-determination due to psychiatric illness\n20. Participating in another interventional clinical trial\n21. Pregnant or unwilling to use medically approved contraception\n22. Deemed inappropriate to participate in this clinical trial by the investigator","MALE","19 Years",{"count":19,"type":20},154,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","A phase 3, multi-center, single-group, open-label study to evaluate the efficacy and safety of DKF-MA102 in patients with prostate cancer.",[26],"Advanced Prostate Cancer","RECRUITING","2024-07-03",{"date":30,"type":31},"2024-07-08","ACTUAL",{"date":33,"type":31},"2024-05-30",{"date":35,"type":20},"2025-05-20",{"name":37,"class":38},"Dongkook Pharmaceutical Co., Ltd.","INDUSTRY",""]