Tests radioactive Lu-PSMA-XT drug in men with metastatic prostate cancer
Tests a radioactive drug, Lu-PSMA-XT, in adults with metastatic prostate cancer.
Plain-language title generated from the registry record
Registry title: A Study of [177Lu] Lu-PSMA-XT Injection in Patients With Metastatic Prostate Cancer
Key facts
- Where
- Beijing, ChinaSee the 3 sites
- Phase
- Phase 1
Where in China
- Beijing Cancer HospitalBeijing, ChinaTaking people
- Mianyang Central HospitalBeijing, ChinaTaking people
- The First Medical Center, Chinese PLA General HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jinming Zhang
- Trial code
- NCT07096128
- Record updated
- 31 July 2025
- Original description
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 .Read full original descriptionShow less
A Phase I Study to Assess the Safety, Tolerability, Radiation Dosimetry and Efficacy of [177Lu] Lu-PSMA-XT in Patients With Metastatic Prostate Cancer
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 .
Inclusion: Patients must have the ability to understand and sign an approved informed consent form (ICF); Patients must be >= 18 and <＝80 years of age; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Patients must have a life expectancy >6 months; Patients must have histological, pathological, and/or cytological confirmation of prostate cancer; Patients must be PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive。; Patients must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L); Patients must 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; Patients must have progressive mCRPC; Patients must 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.
Exclusion: 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; Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment; Known other malignancies; Known hypersensitivity to the components of the study therapy or its analogs; 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; A superscan as seen in the baseline bone scan.