Randomized Controlled Study on the Efficacy and Safety of Intermittent Darolutamide Treatment in the Triple Therapy of Metastatic Hormone Sensitive Prostate Cancer
To evaluate the efficacy and safety of intermittent use of darolutamide compared to long-term use in combination with ADT and docetaxel in the treatment of mHSPC patients.
⁃ Patients must meet all of the following criteria to be eligible for this study:
• Male aged ≥18 years;
• Histologically or cytologically confirmed prostate adenocarcinoma;
• Metastatic disease (confirmed by conventional imaging);
• ECOG performance status of 0-1;
• Suitable for ADT and docetaxel treatment;
• 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):
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN
• Total bilirubin (TBIL) ≤ 2.0 × ULN;
• Serum creatinine (Cr) ≤ 2.0×ULN;
⁃ 7\. Willing to participate in this study, sign an informed consent form, and have good compliance