[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627157":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":47,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":20,"overallStatus":68,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Fujian Medical University Union Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Rezvilutamide plus ADT (Leuprorelin)","EXPERIMENTAL","Participants will receive Rezvilutamide (240 mg daily) plus ADT (Leuprorelin 3.75mg every 28 days) for 12 cycles, followed by Rezvilutamide monotherapy (240 mg daily) for up to 12 additional cycles. The total treatment duration is up to 24 cycles.",[13],"Drug: Rezvilutamide and Leuprorelin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Rezvilutamide and Leuprorelin","Combination Phase (Cycles 1-12): Rezvilutamide 240 mg orally once daily, combined with Leuprorelin 3.75 mg via subcutaneous injection every 28 days.\n\nMaintenance Phase (Cycles 13-24): Rezvilutamide 240 mg orally once daily as monotherapy.\n\nDuration: Each cycle is 28 days. The total treatment duration is up to 24 cycles (approximately 2 years). This study specifically focuses on the adjuvant intensive endocrine therapy for high-risk patients following radical prostatectomy.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Mengqiang Li","Department of Urology, Fujian Union Hospital, Fujian Medical University","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Jiabing Zheng","CONTACT","+8613799422519","xhyykjk@163.com",[33],{"facility":24,"status":20,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Fuzhou","Fujian","350000","China","CN",{"type":40,"coordinates":41},"Point",[42,43],119.30611,26.06139,{"lat":43,"lon":42},[46],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100627157","rezvilutamide-for-high-risk-prostate-cancer-after-surgery-100627157",false,"NCT07444983","Rezvilutamide for High-Risk Prostate Cancer After Surgery","An Exploratory Clinical Study of Rezvilutamide as Adjuvant Therapy for High-Risk Patients After Radical Prostatectomy","Inclusion Criteria\n\nSubjects must meet all of the following criteria to be eligible for entry into this study:\n\nAge ≥ 18 years.\n\nHistologically confirmed adenocarcinoma of the prostate following radical prostatectomy.\n\nEvaluated by the investigator as requiring pharmacological treatment.\n\nECOG Performance Status of 0 or 1.\n\nPreoperative imaging ruled out metastatic disease.\n\nMust meet at least one of the following postoperative high-risk factors:\n\nPositive surgical margins;\n\nPathological stage pT3-pT4;\n\nLymph node metastasis;\n\nPreoperative PSA ≥ 20 ng\u002Fml.\n\nUnwilling to receive postoperative radiotherapy.\n\nPSA \\\u003C 0.1 ng\u002Fml during the screening period.\n\nCapable of understanding and voluntarily signing the Informed Consent Form (ICF).\n\nExclusion Criteria\n\nPatients meeting any of the following criteria will be excluded from the study:\n\nPostoperative pathology contains non-adenocarcinoma components, such as neuroendocrine differentiation or small cell features.\n\nKnown or suspected hypersensitivity to Rezvilutamide or any of its excipients.\n\nFactors affecting drug administration or absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction.\n\nHistory of seizures or presence of conditions predisposing to seizures within 12 months prior to screening (including history of transient ischemic attack, stroke, or traumatic brain injury with loss of consciousness requiring hospitalization).\n\nActive cardiac disease within 6 months prior to screening, including: severe\u002Funstable angina, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medical treatment.\n\nHistory of other malignancies within 3 years prior to screening (except for completely remitted carcinoma in situ or malignancies judged by the investigator to be slow-progressing).\n\nActive HBV or HCV infection (HBV DNA ≥ 10\\^4 copies\u002FmL, HCV RNA ≥ 10\\^3 copies\u002FmL).\n\nHistory of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases) or history of organ transplantation.\n\nMale subjects with female partners of childbearing potential who refuse surgical sterilization or refuse to use effective contraception during the study period.\n\nAny other condition which, in the opinion of the investigator, may interfere with the conduct of the study, compromise protocol compliance, or pose an unacceptable risk to the subject.","MALE","18 Years","95 Years",{"count":60,"type":61},33,"ESTIMATED","INTERVENTIONAL",[64],"NA","The goal of this clinical trial is to learn if Rezvilutamide works to treat high-risk prostate cancer in patients who have recently undergone surgery (radical prostatectomy). It will also learn about the safety of Rezvilutamide. The main questions it aims to answer are:\n\nDoes Rezvilutamide, when used as an add-on treatment after surgery, lower the risk of the cancer returning (biochemical recurrence) within 3 years? What is the 36-month metastasis-free survival (MFS) rate for patients receiving this treatment? What is the safety profile of Rezvilutamide combined with ADT, specifically regarding the types, grades, and incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Adverse Events of Special Interest (AESIs), and rare adverse events? What are the exploratory findings regarding the status of immune cells after using Rezvilutamide?\n\nResearchers will evaluate the combination of Rezvilutamide and hormone therapy (ADT) to see if it helps keep patients cancer-free.\n\nParticipants will:\n\nTake Rezvilutamide: 240 mg once daily, taken orally before or after breakfast. Each cycle is 28 days, for up to 24 cycles. Treatment continues unless biochemical recurrence, disease progression, intolerable toxicity occurs, or the participant withdraws consent, as determined by the investigator.\n\nReceive Androgen Deprivation Therapy (ADT): Leuprorelin 3.75mg via subcutaneous injection, once every 28 days for a total of 12 cycles.",[67],"Prostate Cancer (Adenocarcinoma)","NOT_YET_RECRUITING","2026-03-02",{"date":71,"type":72},"2026-03-03","ACTUAL",{"date":74,"type":61},"2026-02-11",{"date":76,"type":61},"2029-07-11",{"name":5,"class":6},1]