Clinical Research Directory

Inclusion Criteria: Patients must meet all of the following criteria to be eligible for this study: 1. Male aged ≥18 years; 2. Histologically or cytologically confirmed prostate adenocarcinoma; 3. Metastatic disease (confirmed by conventional imaging); 4. ECOG performance status of 0-1; 5. Suitable for ADT and docetaxel treatment; 6. Good bone marrow, kidney, and liver function: 1\. (1) Hematological examination (no blood transfusion or use of hematopoietic growth factors within 7 days before screening): 1\. Hemoglobin (HB) ≥ 90g/L; 2. Absolute neutrophil count (ANC) ≥ 1.5×109/L; 3. Platelets (PLT) ≥ 80×109/L; 2. (2) Blood biochemistry examination (no blood transfusion or albumin within 7 days before screening): 1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN 2. Total bilirubin (TBIL) ≤ 2.0 × ULN; 3. Serum creatinine (Cr) ≤ 2.0×ULN; 7\. Willing to participate in this study, sign an informed consent form, and have good compliance Exclusion Criteria: 1. No metastatic disease; 2. Prior treatment with: a) Second-generation ARis or other experimental ARis b) CYP17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole for anti-tumor treatment of prostate cancer c) Chemotherapy or immunotherapy prior to randomization for prostate cancer 3. Received radiotherapy within 2 weeks before starting 6 months of darolutamide + docetaxel + ADT treatment; 4. Stroke, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass surgery, congestive heart failure (New York Heart Association class III or IV); 5. History of malignant tumors; 6. Planned receipt of other anti-tumor treatment during the study treatment period; 7. Known allergy to the above drug components; 8. Difficulty swallowing, chronic diarrhea, intestinal obstruction, and various factors affecting drug intake and absorption; 9. Refusal to sign the informed consent form; 10. Investigator's opinion that the participant is not suitable for inclusion.