Prostate cancer with bone metastasis
Conditions
Interventions
Experimental group:177Lu-TBM-001
Sponsors
West Southwest Medical University Affiliated Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.The patient is able to understand and voluntarily sign an approved informed consent form (ICF); 2.Age >= 18 years old, 2 ng/ml. b) Imaging progress: Emergence of new lesions, including 2 or more new bone metastases on bone scan or new soft tissue lesions evaluated using RECIST criteria. The patient must have histologically, pathologically, and/or cytologically confirmed prostate cancer that is not responding to or progressing from conventional clinical treatments (including endocrine therapy, chemotherapy, radiotherapy, and novel androgen inhibitors); 5.Expected survival > 6 months; 6.The functional status score of the Eastern Tumor Collaboration Group (ECOG) was = 2; 7.Baseline 68Ga-PSMA and 68Ga-TBM-001 PET/CT imaging showed high uptake lesions; 8.Adequate bone marrow, liver and kidney functions are defined as follows: a) White blood cells (WBC) >= 2.5*10^9/L b) Platelets >= 100*10^9/L c) Hemoglobin >= 9 g/dL d) Total bilirubin = 50 mL/min. 9.All other pre-existing toxicity ratings need to be <= NCI-CTCAE v5.0 Level 0 or 1. 10.Agree that contraception must be used during the study period and for 6 months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1.Previous or current uncontrolled primary or metastatic brain tumor. 2.Patients with spinal cord compression and pathological fracture. 3.Combined with DIC or serious bone marrow hematopoietic dysfunction. 4.Poor bone marrow reserve was expected, and 68Ga-PSMA or 68Ga-TBM-001PET/CT imaging suggested diffuse bone metastases throughout the body. 5.Patients who have received nuclide therapy within 6 months. 6.Receive chemotherapy, radiotherapy, immunotherapy, or clinical trial drugs within 28 days. 7.Allergy, or allergy to known investigational drug ingredients or excipients. 8.Suffer from claustrophobia or for other reasons cannot tolerate the imaging operator. 9.Active infection with clinical significance as judged by the investigator . 10.Other severe and/or poorly controlled and/or unstable medical conditions that the investigator determines may affect the study, including but not limited to: a) Poorly controlled diabetes b) Congestive heart failure c) Myocardial infarction in the past 12 months d) Unstable and difficult to control hypertension e) Chronic kidney or liver disease f) Severe lung disease. 11.Subjects with poor compliance who are expected to be unable to complete the test procedure, or other subjects deemed unsuitable for clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiation Dosimetry: Collect biodistribution and radiation dose data for the whole body and major tissues/organs at various time points after drug administration;The incidence and severity of adverse events (AEs),;Serious adverse events (SAEs);SREs;68Ga-PSMA+68Ga-TBM PET/CT;PSA;KPS?NRS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival and progression-free survival were analyzed; | — |
Countries
China
Contacts
Public ContactChen Yue
West Southwest Medical University Affiliated Hospital
Outcome results
None listed