Actively Recruiting
A Study of [177Lu] Lu-PSMA-XT Injection in Patients With Metastatic Prostate Cancer
Led by Jinming Zhang · Updated on 2025-07-31
36
Participants Needed
3
Research Sites
140 weeks
Total Duration
On this page
Sponsors
J
Jinming Zhang
Lead Sponsor
S
Sinotau Pharmaceutical Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
This was a multicenter, open-label, phase I study to evaluate the safety, tolerability, radiation dosimetry and efficacy of \[177Lu\] Lu-PSMA-XT injection in patients with metastatic prostate cancer .
CONDITIONS
Official Title
A Study of [177Lu] Lu-PSMA-XT Injection in Patients With Metastatic Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent
- Age 18 to 80 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 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 level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L)
- Received at least one androgen receptor axis-directed therapy (e.g., enzalutamide or abiraterone)
- Received 1-2 prior 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 for subjects of childbearing potential
You will not qualify if you...
- Treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, or hemi-body irradiation within 6 months
- Previous PSMA-targeted radioligand therapy
- Presence of other known cancers
- Systemic anti-cancer therapy within 28 days before enrollment
- Known hypersensitivity to study therapy components or analogs
- Superscan on baseline bone scan
- History of central nervous system metastases
- Uncontrolled or active illness including infection, symptomatic heart failure, cardiac arrhythmia, or severe complications
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
2
Mianyang Central Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
3
The First Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
J
Jinming Zhang
CONTACT
J
Jinming Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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