Metastatic Castration-resistant Prostate Cancer (mCRPC)Phase 2NCT07164794
Memantine Hydrochloride in Prostate Cancer Patients
A Phase 2 study testing Memantine Hydrochloride in people with Metastatic Castration-resistant Prostate Cancer (mCRPC) and Prostate Cancer, run by Bin Xu.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer (mCRPC), Prostate Cancer, Neuroendocrine Prostate Cancer (NEPC)
- What is being tested?
- Memantine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with metastatic prostate cancer at initial diagnosis who have not progressed to mCRPC.
- Patients with a concurrent primary malignancy at another site.
About this study
Official title: 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?
Read more
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)
- Being tested
- Memantine Hydrochloride
- Keywords
- Memantine, mCRPC, Prospective Study
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Memantine Hydrochloride | Experimental | 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. Receives: Drug: Memantine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study startNov 2025 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bin Xu
- Sponsor type
- University, hospital or other
- Collaborators
- The First People's Hospital of Lianyungang
- Responsible party
- Sponsor-investigator, Bin Xu, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164794
- Sponsor's protocol ID
- 2025ZDSYLL297-P01
- Status last verified
- Nov 2025
- First submitted
- 13 Aug 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the publication of primary study results in a peer-reviewed journal, de-identified individual participant data (IPD) that underlie the results, as well as the study protocol, will be made available upon reasonable request to the Principal Investigator (PI).
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Memantine Hydrochloride for the Treatment of Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT07164794
- Acronym / sponsor ID
- 2025ZDSYLL297-P01
- Conditions
- Metastatic Castration-resistant Prostate Cancer (mCRPC), Prostate Cancer, Neuroendocrine Prostate Cancer (NEPC)
- Keywords
- Memantine, mCRPC, Prospective Study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Bin XuUniversity, hospital or other
- Collaborators
- The First People's Hospital of Lianyungang
- Study start
- Nov 2025 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Memantine Hydrochloride | Experimental | Drug: Memantine HydrochlorideParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with metastatic prostate cancer at initial diagnosis who have not progressed to mCRPC.
- Patients with a concurrent primary malignancy at another site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memantine HydrochlorideMemantine 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. | Drug | Experimental: Memantine Hydrochloride |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: Yes. After the publication of primary study results in a peer-reviewed journal, de-identified individual participant data (IPD) that underlie the results, as well as the study protocol, will be made available upon reasonable request to the Principal Investigator (PI).
Related trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Active, not recruitingPhase 3
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
mCRPC
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Memantine Hydrochloride in people with Metastatic Castration-resistant Prostate Cancer (mCRPC) and Prostate Cancer, run by Bin Xu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.