Metastatic Castration-Resistant Prostate Cancer PatientsPhase 1NCT07135102
A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of [225Ac]Ac-PSMA-XT Injection in Patients With Metastatic Castration-resistant Prostate Cancer
A Phase 1 study testing 225Ac-PSMA-XT in people with Metastatic Castration-Resistant Prostate Cancer Patients, run by Xiaorong Sun at 1 site in China.
Trial summary
The purpose of this study is to determine the safety and efficacy of 225Ac -labeled PSMA ligand(PSMA-XT) in the treatment of mCRPC 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 Patients
- What is being tested?
- 225Ac-PSMA-XT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2024to 1 Jun 2027
- Phase
- Phase 1
- 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
- have the ability to understand and sign an approved informed consent form (ICF).
- >= 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- have a life expectancy >6 months.
- have histological, pathological, and/or cytological confirmation of prostate cancer.
- PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive
Show all 11Show fewer
- have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
- have received at least one NAAD (such as enzalutamide and/or abiraterone)； patients must have been previously treated undergone at least 1-2 prior taxane-based chemotherapy regimens or be unsuitable for taxane therapy (unsuitability includes contraindications, investigator-determined ineligibility, or patient refusal) in mCRPC stage.
- progressive mCRPC.
- have adequate organ function。
- Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, Intra-uterine device（IUD）,etc., during treatment and within 6 months of the last use of the trial drug.
Who cannot join
- Previous treatment with any of the following within 6 months of enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
- Known other malignancies.
- Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.
- Known hypersensitivity to the components of the study therapy or its analogs.
- A superscan as seen in the baseline bone scan.
- Patients with a history of Central Nervous System (CNS) metastases.
- Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or other severe complications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 100023
Xiaorong Sun, 0531-67626287, xrsun@sdfmu.edu.cn
About this study
The purpose of this study is to determine the safety and efficacy of 225Ac -labeled PSMA ligand(PSMA-XT) in the treatment of mCRPC
- Being tested
- 225Ac-PSMA-XT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
225Ac-PSMA-XTDrug
Patients will receive 225Ac-PSMA-XT administration at an interval of 6 weeks between each dose.
| Study group | Role | What they receive |
|---|---|---|
| 225Ac-PSMA-XT treatment | Experimental | Not described Receives: Drug: 225Ac-PSMA-XT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events
To evaluate the safety and tolerability of [177Lu]Lu-PSMA-XT Injection assessed from the number and incidence of patients with adverse events using CTCAE v5.0 and physical examination, electrocardiogram and laboratory abnormality, etc.
Measured: Through study completion, assessed up to 2 years
Dose-limiting toxicity（DLT）
Incidence and severity of dose-limiting toxicities.
Measured: Through study completion, assessed up to 2 years
Secondary outcomes (5)
Prostate-specific Antigen 50 (PSA50) Response
PSA50 response was defined as the proportion of participants who had a >= 50% decrease in PSA from baseline confirmed by a PSA measurement >= 4 weeks later.
Measured: Through study completion, assessed up to 2 years.
Radiographic Progression-free Survival (rPFS)
Radiographic progression-free survival (rPFS) was defined as the time (in months) from the date of enrollment to the date of radiographic disease progression per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death due to any cause.
Measured: Through study completion, assessed up to 2 years.
Overall Response Rate (ORR)
Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on RECIST 1.1 response for patients with measurable disease at baseline.
Measured: Through study completion, assessed up to 2 years.
Duration of Response (DOR)
Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause .
Measured: Through study completion, assessed up to 2 years.
Disease Control Rate (DCR)
Disease control rate (DCR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) according to RECIST v1.1.
Measured: Through study completion, assessed up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start14 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jun 2027 (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 PatientsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaorong Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaorong Sun, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135102
- Sponsor's protocol ID
- SDZLEC2024-365-01
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of [225Ac]Ac-PSMA-XT Injection in Patients With Metastatic Castration-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT07135102
- Acronym / sponsor ID
- SDZLEC2024-365-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xiaorong SunUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 21 Aug 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 purpose of this study is to determine the safety and efficacy of 225Ac -labeled PSMA ligand(PSMA-XT) in the treatment of mCRPC
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 225Ac-PSMA-XT treatment | Experimental | Drug: 225Ac-PSMA-XT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- have the ability to understand and sign an approved informed consent form (ICF).
- >= 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- have a life expectancy >6 months.
- have histological, pathological, and/or cytological confirmation of prostate cancer.
Key exclusion criteria (7 listed)
- Previous treatment with any of the following within 6 months of enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
- Known other malignancies.
- Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.
- Known hypersensitivity to the components of the study therapy or its analogs.
- A superscan as seen in the baseline bone scan.
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 |
|---|---|---|
| 225Ac-PSMA-XTPatients will receive 225Ac-PSMA-XT administration at an interval of 6 weeks between each dose. | Drug | 225Ac-PSMA-XT treatment |
Primary outcome
Treatment emergent adverse events
Time frame: Through study completion, assessed up to 2 years
To evaluate the safety and tolerability of [177Lu]Lu-PSMA-XT Injection assessed from the number and incidence of patients with adverse events using CTCAE v5.0 and physical examination, electrocardiogram and laboratory abnormality, etc.
Dose-limiting toxicity（DLT）
Time frame: Through study completion, assessed up to 2 years
Incidence and severity of dose-limiting toxicities.
5 secondary outcomes
Prostate-specific Antigen 50 (PSA50) Response
Time frame: Through study completion, assessed up to 2 years.
Radiographic Progression-free Survival (rPFS)
Time frame: Through study completion, assessed up to 2 years.
Overall Response Rate (ORR)
Time frame: Through study completion, assessed up to 2 years.
Duration of Response (DOR)
Time frame: Through study completion, assessed up to 2 years.
Disease Control Rate (DCR)
Time frame: Through study completion, assessed up to 2 years.
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 24 Aug 2025.
Related trials for Metastatic Castration-Resistant Prostate Cancer Patients
Active, not recruitingPhase 1/2
Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients With Advanced Malignancies
Advanced Malignant Solid Neoplasm, Castration-Resistant Prostate Carcinoma
RecruitingPhase 1
A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer
Metastatic Castration-resistant Prostate Cancer (mCRPC)
RecruitingPhase 1
A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors
NSCLC, NSCLC (Advanced Non-small Cell Lung Cancer)
Active, not recruitingPhase 2
An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC
Metastatic Castration Resistant Prostate Cancer (mCRPC)
RecruitingObservational study
An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea
Non-metastatic Castration-resistant Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 225Ac-PSMA-XT in people with Metastatic Castration-Resistant Prostate Cancer Patients, run by Xiaorong Sun at 1 site in China.
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 11 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment emergent adverse events (time frame: Through study completion, assessed up to 2 years). The study lists 2 primary outcomes in all. 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 24 Aug 2025.