Memantine Hydrochloride in Prostate Cancer Patients

Phase 2Not Yet RecruitingNCT07164794

Bin Xu15 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Interventions

Memantine HydrochlorideDRUG

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

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).

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