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
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the safety and efficacy of 225Ac -labeled PSMA ligand(PSMA-XT) in the treatment of mCRPC
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign an informed consent form
- 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy longer than 6 months
- Confirmed diagnosis of prostate cancer by histology, pathology, or cytology
- Positive PSMA PET/CT scan
- Castrate level of serum/plasma testosterone (less than 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 during treatment and for 6 months after last dose if of childbearing potential
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
- Presence of other known malignancies
- Systemic anti-cancer therapy within 28 days before enrollment
- Known allergy to study treatment or similar compounds
- Superscan observed on baseline bone scan
- History of central nervous system metastases
- Uncontrolled illnesses such as active infections, symptomatic heart failure, arrhythmia, or other severe complications
AI-Screening
AI-Powered Screening
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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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