Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC

Korábbi kezelés

• 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
• Received radiotherapy within 2 weeks before starting 6 months of darolutamide + docetaxel + ADT treatment;
• Difficulty swallowing, chronic diarrhea, intestinal obstruction, and various factors affecting drug intake and absorption;

Más betegség

• No metastatic disease;
• Stroke, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass surgery, congestive heart failure (New York Heart Association class III or IV);
• History of malignant tumors;
• Known allergy to the above drug components;

Egyéb

• Planned receipt of other anti-tumor treatment during the study treatment period;
• Refusal to sign the informed consent form;
• Investigator's opinion that the participant is not suitable for inclusion.

• 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) Hematological examination (no blood transfusion or use of hematopoietic growth factors within 7 days before screening):
• 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;
• Willing to participate in this study, sign an informed consent form, and have good compliance