[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605613":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":20,"responsibleParty":21,"collaborators":25,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":20,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":20,"enrollmentInfo":37,"targetDuration":20,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":48,"overallStatus":52,"whyStopped":20,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":20},{"fullName":5,"class":6},"Zhongda Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Memantine Hydrochloride","EXPERIMENTAL","Participants will receive the study drug, memantine hydrochloride, in addition to their ongoing standard of care treatment. The standard of care background therapy consists of Androgen Deprivation Therapy (ADT) using a GnRH agonist or antagonist , combined with a novel endocrine therapy such as abiraterone acetate or enzalutamide, based on the patient's prior treatment history.\n\nThe dosing for memantine hydrochloride is as follows:\n\nWeek 1: 5 mg once daily. Week 2: 10 mg once daily. Week 3: 15 mg once daily. Week 4 and thereafter: 20 mg once daily as a maintenance dose.",[13],"Drug: Memantine Hydrochloride",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Memantine Hydrochloride","Memantine Hydrochloride is administered orally, once daily, in combination with the patient's ongoing standard of care treatment for metastatic castration-resistant prostate cancer (mCRPC).\n\nThe dosing follows a weekly titration schedule for the first three weeks to reach the maintenance dose.\n\nWeek 1: 5 mg once daily. Week 2: 10 mg once daily. Week 3: 15 mg once daily. Week 4 and onwards: 20 mg once daily. This intervention is being studied to evaluate its potential to reduce neuroendocrine differentiation and correct castration resistance in advanced prostate cancer.",[9],null,{"type":22,"investigatorFullName":23,"investigatorTitle":24,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Bin Xu","Researcher",[26],{"name":27,"class":6},"The First People's Hospital of Lianyungang","100605613","phase-2-memantine-hydrochloride-in-prostate-cancer-patients-100605613",false,"NCT07164794","Memantine Hydrochloride in Prostate Cancer Patients","A Prospective Study of Memantine Hydrochloride for the Treatment of Prostate Cancer Patients","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patients with metastatic castration-resistant prostate cancer (mCRPC) who have failed one or two prior lines of therapy. Patients with concomitant Alzheimer's disease will be prioritized for enrollment.\n3. Complete clinical baseline data must be available, and the patient must be willing to undergo long-term follow-up.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n\nExclusion Criteria:\n\n1. Patients with metastatic prostate cancer at initial diagnosis who have not progressed to mCRPC.\n2. Patients with a concurrent primary malignancy at another site.","MALE","18 Years",{"count":38,"type":39},15,"ESTIMATED","INTERVENTIONAL",[42],"PHASE2","The goal of this clinical trial is to learn if long-term use of memantine hydrochloride can treat, prevent, or correct castration resistance and drug resistance in advanced prostate cancer. The study will enroll male patients aged 18 and older diagnosed with metastatic castration-resistant prostate cancer (mCRPC) who have previously failed first or second-line treatments. The main questions it aims to answer are:\n\nWhat is the progression-free survival (PFS) in patients treated with memantine hydrochloride? What is the disease control rate (DCR) and what is the change in Prostate-Specific Antigen (PSA) levels after treatment?\n\nResearchers will compare outcomes from participants in this single-arm study to an external historical control group of patients who received traditional treatment to see if the addition of memantine hydrochloride improves prognosis.\n\nParticipants will be asked to do the following:\n\nContinue their standard of care treatment, which includes Androgen Deprivation Therapy (ADT) and a novel endocrine therapy.\n\nTake the study drug, memantine hydrochloride, with the dose gradually increasing over the first three weeks to a maintenance dose.\n\nAttend regular follow-up appointments for blood tests to check PSA levels and undergo imaging scans to monitor the disease status. These follow-ups will occur one month after starting the drug and every three months thereafter.",[45,46,47],"Metastatic Castration-resistant Prostate Cancer (mCRPC)","Prostate Cancer","Neuroendocrine Prostate Cancer (NEPC)",[49,50,51],"Memantine","mCRPC","Prospective Study","NOT_YET_RECRUITING","2025-11-15",{"date":55,"type":56},"2025-11-19","ACTUAL",{"date":58,"type":39},"2025-11",{"date":60,"type":39},"2028-06",{"name":23,"class":6}]