Metastatic castration-resistant prostate cancer (mCRPC)
Conditions
Interventions
177Lu-PSMA treatment group:177Lu-PSMA treatment
Sponsors
Shanghai General 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 the approved Informed Consent Form (ICF); 2. Age >= 18 years and 2 ng/ml. Radiographic progression: emergence of new lesions, including at least 2 new bone metastatic lesions indicated by bone scan, or newly developed soft tissue lesions assessed by RECIST criteria. 4. Patients must have histologically, pathologically, and/or cytologically confirmed prostate cancer and have disease progression or lack of response to standard clinical treatments (including endocrine therapy, chemotherapy, radiotherapy, novel androgen inhibitors, etc.); 5. Expected survival > 6 months; 6. Eastern Cooperative Oncology Group (ECOG) performance status = 2.5 × 10^9/L; platelet count >= 100 × 10^9/L; hemoglobin >= 9 g/dL; total bilirubin = 50 mL/min. 9. All other existing toxicities must be <= grade 0 or 1 according to NCI-CTCAE v5.0; 10. Agreement to use contraception during the study and for 6 months after the study ends.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of or current uncontrolled primary or metastatic brain tumors; 2. Patients with spinal cord compression or pathological fractures; 3. Patients with DIC (disseminated intravascular coagulation) or severe bone marrow hematopoietic dysfunction; 4. Patients with expected poor bone marrow reserve function, or those with diffuse bone metastases indicated by 68Ga-PSMA PET/CT imaging; 5. Patients who have received radionuclide therapy within the past 6 months; 6. Patients who have received chemotherapy, radiotherapy, immunotherapy, or investigational drug treatments within the past 28 days; 7. Patients with allergies, or who are allergic to known components or excipients of the investigational drug; 8. Patients with claustrophobia or who are unable to tolerate imaging procedures for other reasons; 9. Patients with clinically significant active infections as judged by the investigator; 10. Patients with severe and/or poorly controlled and/or unstable other diseases that, in the investigator's judgment, may affect the study, including but not limited to: poorly controlled diabetes; congestive heart failure; myocardial infarction within the past 12 months; unstable and difficult-to-control hypertension; chronic kidney or liver disease; severe pulmonary disease; 11. Patients with poor compliance who are expected to be unable to complete the trial procedures, or other patients deemed unsuitable to participate in the clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiation doses to major organs and tumors following treatment with 177Lu-PSMA-617; | — |
Countries
China
Contacts
Public ContactYan Xing
Shanghai General Hospital
Outcome results
None listed