NCT07164794

Memantine Hydrochloride in Prostate Cancer Patients

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Bin Xu · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-11-01
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2025-09-10
• Last updated: 2025-11-19