Memantine Hydrochloride in Prostate Cancer Patients

NCT ID: NCT07164794

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2028-06-30

Brief 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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Memantine Hydrochloride

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.

The dosing for memantine hydrochloride is as follows:

Week 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.

Group Type: EXPERIMENTAL

Memantine Hydrochloride

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years

2. 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.

3. Complete clinical baseline data must be available, and the patient must be willing to undergo long-term follow-up.

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Exclusion Criteria

1. Patients with metastatic prostate cancer at initial diagnosis who have not progressed to mCRPC.

2. Patients with a concurrent primary malignancy at another site.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The First People's Hospital of Lianyungang

OTHER

Sponsor Role: collaborator

Bin Xu

OTHER

Sponsor Role: lead

Responsible Party

Bin Xu

Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2025ZDSYLL297-P01

Identifier Type: -

Identifier Source: org_study_id