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Not yet recruiting NCT07164794

Memantine Hydrochloride in Prostate Cancer Patients

Phase II Interventional Metastatic Castration-resistant Prostate Cancer (mCRPC) Prostate Cancer Neuroendocrine Prostate Cancer (NEPC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Memantine Hydrochloride.
Who it may be relevant to
Registry conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC), Prostate Cancer, Neuroendocrine Prostate Cancer (NEPC). Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Study of Memantine Hydrochloride for the Treatment of Prostate Cancer Patients

Overview

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.

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 dif

Primary outcome measures

  • Progression-Free Survival (PFS) [Time frame: 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]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years
  • 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.
  • Complete clinical baseline data must be available, and the patient must be willing to undergo long-term follow-up.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Exclusion criteria

  • Patients with metastatic prostate cancer at initial diagnosis who have not progressed to mCRPC.
  • Patients with a concurrent primary malignancy at another site.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07164794 · 2025ZDSYLL297-P01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗