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NCT Number: NCT07164794

Memantine Hydrochloride in Prostate Cancer Patients

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Memantine Hydrochloride

Drug

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.

Primary outcomes

  1. 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

    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).

Sponsors and collaborators

Lead sponsor

Bin Xu

Other

Collaborators

  • The First People's Hospital of Lianyungang

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 10, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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