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Memantine Hydrochloride in Prostate Cancer Patients

NCT07164794 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-11-19

No results posted yet for this study

Summary

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:

What 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?

Researchers 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.

Participants will be asked to do the following:

Continue their standard of care treatment, which includes Androgen Deprivation Therapy (ADT) and a novel endocrine therapy.

Take the study drug, memantine hydrochloride, with the dose gradually increasing over the first three weeks to a maintenance dose.

Attend 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.

Conditions

  • Metastatic Castration-resistant Prostate Cancer (mCRPC)
  • Prostate Cancer
  • Neuroendocrine Prostate Cancer (NEPC)

Interventions

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). The dosing follows a weekly titration schedule for the first three weeks to reach the maintenance dose. Week 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.

Sponsors & Collaborators

  • The First People's Hospital of Lianyungang

    collaborator OTHER

  • Bin Xu

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2028-06-30
Completion
2028-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07164794 on ClinicalTrials.gov