prostate cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who meet all the following criteria can be selected for this study: 1. Prior to participating in the study, a signed informed consent form must be obtained. 2. Male patients aged = 18 years old. 3. Prostate cancer confirmed by histology or cytology. 4. Regular imaging examination confirmed or suspected metastatic hormone sensitive prostate cancer (mHSPC) or metastatic castration resistant prostate cancer (mCRPC): confirmed or suspected at least 1 bone and/or soft tissue/visceral metastasis: a Baseline 99mTc MDP bone scan imaging or other examinations showed bone metastasis at any location; And/or b. lymph node metastasis of any size or distribution; And/or c. Any size or distribution of visceral metastasis. Patients confirmed to have liver metastasis and retroperitoneal metastasis through routine imaging examination will be prioritized for inclusion. 5. The ECOG score is 0-2 points. 6. Adequate organ function: Bone marrow reserve: Neutrophil count (ANC) = 1.5 × 10 ^ 9/L, platelet count = 100 × 10 ^ 9/L, hemoglobin = 90g/L; Liver: total bilirubin (TBIL) = 1.5 times the upper limit of normal value (ULN), alanine aminotransferase (ALT) and Asparagus cochinchinensis aminotransferase (AST) = 3.0 × ULN; Kidney: blood creatinine (SCr) = 1.5 × ULN.
Exclusion criteria
Exclusion criteria: 1. Previously received PSMA targeted radioligand therapy. 2. Participating in any other clinical trial or receiving experimental drugs. 3. Patients with central nervous system (CNS) metastasis accompanied by symptoms or receiving glucocorticoid treatment to maintain the functional integrity of the nervous system. 4. Patients who merge with other malignant tumors that may interfere with disease assessment, have a history of malignant tumors but have been adequately treated, have not received treatment for more than 3 years before enrollment, and have no evidence of recurrence are eligible to participate in the study. 5. Medical diseases combined with severe or poorly controlled diseases, including but not limited to uncontrollable infections (including severe or poorly recovered COVID-19 infections), known active hepatitis B or hepatitis C, or other diseases that the researcher believes may impair research participation or cooperation. 6. A physical or mental illness history that may interfere with the research purpose and evaluation, or any situation where the researcher determines that the patient is unable to cooperate with imaging examinations and procedures. 7. Patients who do not agree to effective contraceptive measures or restrictive sexual behavior. 8. There are other conditions that the researcher believes are not suitable for participating in the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum standardized uptake value;absorbed dose;effective dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| the incidence types and severity of adverse events;the incidence rate and frequency of adverse events; | — |
Countries
China
Contacts
Affiliated Hospital of North Sichuan Medical College