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A Prospective Study of Memantine Hydrochloride for the Treatment of 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.
Details
| Lead sponsor | Bin Xu |
|---|---|
| Phase | Phase 2 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 15 |
| Start date | 2025-11 |
| Completion | 2028-06 |
Conditions
- Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Prostate Cancer
- Neuroendocrine Prostate Cancer (NEPC)
Interventions
- Memantine Hydrochloride
Primary outcomes
- Progression-Free Survival (PFS) — 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).