Prostate cancer
Conditions
Interventions
therapeutic group:Subjects will receive 177Lu-PSMA injection intravenously during treatment at an interval of 6±2 weeks, and the first cycle of treatment will be the DLT evaluation period, with a maxi
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: (1) pathologically confirmed (adenocarcinoma) metastatic castration-resistant prostate cancer in which the disease has progressed after standard treatment with taxane-based chemotherapy and second-generation antiandrogens (abiraterone, enzalutamide, or a combination of both), unless the patient is medically unfit or rejects these standard treatments; (2) Radiographic progression (based on solid tumor response assessment criteria [RECIST] or bone scan) or new pain at the site of the lesion with radiological evidence was defined as entrainable progression. Patients are required to have an Eastern Tumor Assistance Group (ECOG) performance score of 2 or lower and a life expectancy of more than 12 weeks. (4) PSMA PET/CT and/or PET/MRI imaging proved that patients had high PSMA expression.
Exclusion criteria
Exclusion criteria: (1) Clinically significant impairment of bone marrow, liver and kidney function, such as platelet count < 75×109/L, neutrophil count < 1.5×109/L, hemoglobin concentration < 90g/L or albumin concentration < 25g/L, and GFR < 40ml/min. (2) Concurrent use of nephrotoxic drugs, recent (within 6 weeks) radiation therapy for a single evaluable lesion or uncontrollable complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| lifetime;RECIST;PSA; | — |
Countries
China
Contacts
Public ContactWang Xinlu
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed