Actively Recruiting
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
Led by Xiaorong Sun · Updated on 2025-08-24
40
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a new drug called 225Ac-labeled PSMA ligand (PSMA-XT) for treating metastatic castration-resistant prostate cancer (mCRPC). This phase 1 clinical study focuses on men with mCRPC who have progressed despite prior treatments including hormone therapies and chemotherapy. The goal is to understand how well this drug works and how safe it is for patients with this advanced prostate cancer. Participants in this study receive the 225Ac-PSMA-XT drug through injections given every six weeks. This treatment is being carefully monitored for any side effects or toxicities over the course of the study. The study does not use a placebo or comparison group; all enrolled patients receive the experimental treatment. The study period includes assessments up to two years to observe treatment effects and safety. During the study, participants will undergo regular evaluations including scans, blood tests, and clinical exams to monitor their cancer status and any side effects. Researchers will track prostate-specific antigen (PSA) responses, disease progression, overall response rates, and the duration of any benefits. Safety is closely watched by recording any adverse events and dose-limiting toxicities. Patients will be followed for up to two years to gather comprehensive information on treatment impact and tolerability.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent
- Male, 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy greater than 6 months
- Confirmed diagnosis of prostate cancer by histology, pathology, or cytology
- Positive PSMA PET/CT scan
- Castrate serum/plasma testosterone level (<50 ng/dL or <1.7 nmol/L)
- Received at least one novel androgen axis drug such as enzalutamide or abiraterone
- Previously treated with 1-2 taxane-based chemotherapy regimens or unsuitable for taxane therapy
- Progressive metastatic castration-resistant prostate cancer
- Adequate organ function
- Use of effective contraception if of childbearing potential during treatment and for 6 months after last dose
You will not qualify if you...
- Previous treatment within 6 months with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, or hemi-body irradiation
- Prior PSMA-targeted radioligand therapy
- Other known malignancies
- Systemic anti-cancer therapy within 28 days prior to enrollment
- Known hypersensitivity to study therapy components or analogs
- Presence of superscan on baseline bone scan
- History of central nervous system metastases
- Uncontrolled illness such as active infection, symptomatic heart failure, arrhythmia, or severe complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until discontinuation
Participants receive 225Ac-PSMA-XT injections with 6 weeks between each dose to evaluate safety, tolerability, and preliminary efficacy.
Visits every 6 weeks for dosing and assessments
Duration - Up to 2 years
Participants are monitored for treatment emergent adverse events and long-term outcomes after treatment ends.
Periodic visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 100023
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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