Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 2:45 AM
Study NCT ID:
NCT07164794
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Memantine Hydrochloride in Prostate Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008559', 'term': 'Memantine'}], 'ancestors': [{'id': 'D000547', 'term': 'Amantadine'}, {'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-07-22', 'size': 396710, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-29T12:32', 'hasProtocol': True}, {'date': '2025-07-22', 'size': 195359, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-08-29T12:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-15', 'studyFirstSubmitDate': '2025-08-13', 'studyFirstSubmitQcDate': '2025-09-07', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Assessed at 1 month post-treatment initiation, and every 3 months thereafter, until disease progression, death, or study completion, up to a maximum of 1 year', 'description': 'PFS is defined as the time from treatment initiation to the first documentation of disease progression or death from any cause, whichever comes first. Disease progression is a composite event, defined by either biochemical progression (per PCWG3 criteria using blood PSA levels) or radiological progression (per RECIST 1.1 criteria using imaging such as pelvic CT or prostate MRI).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Memantine', 'mCRPC', 'Prospective Study'], 'conditions': ['Metastatic Castration-resistant Prostate Cancer (mCRPC)', 'Prostate Cancer', 'Neuroendocrine Prostate Cancer (NEPC)']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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."}, 'identificationModule': {'nctId': 'NCT07164794', 'briefTitle': 'Memantine Hydrochloride in Prostate Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Zhongda Hospital'}, 'officialTitle': 'A Prospective Study of Memantine Hydrochloride for the Treatment of Prostate Cancer Patients', 'orgStudyIdInfo': {'id': '2025ZDSYLL297-P01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Memantine Hydrochloride', 'description': "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.", 'interventionNames': ['Drug: Memantine Hydrochloride']}], 'interventions': [{'name': 'Memantine Hydrochloride', 'type': 'DRUG', 'description': "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.", 'armGroupLabels': ['Experimental: Memantine Hydrochloride']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'After the publication of primary study results in a peer-reviewed journal, de-identified individual participant data (IPD) that underlie the results, as well as the study protocol, will be made available upon reasonable request to the Principal Investigator (PI).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bin Xu', 'class': 'OTHER'}, 'collaborators': [{'name': "The First People's Hospital of Lianyungang", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Bin Xu', 'investigatorAffiliation': 'Zhongda Hospital'}}}}