The purpose of this study is to investigate the clinical efficacy and safety of darolutamide combined with androgen deprivation therapy (ADT) and different dose-intensity docetaxel chemotherapy in the treatment of patients with metastatic hormone-sensitive prostate cancer.
Study Type
OBSERVATIONAL
Enrollment
50
According to the relative dose intensity of docetaxel (RDI; Defined as the ratio of the dose received to the full planned dose of 75mg/m2 per 6 cycles specified in the protocol) were divided into cohort 1 (patients receiving docetaxel dose intensity ≤80%) and cohort 2 (patients receiving docetaxel dose intensity ≤80%). A total of 50 patients who received docetaxel dose intensity \> 80% were planned to be enrolled, including 25 patients in the docetaxel dose intensity ≤80% group and 25 patients in the docetaxel dose intensity \> 80% group
6-month prostate-specific antigen (PSA) undetectable rate
The proportion of patients with PSA \<0.2 ng/mL after 6 months of treatment
Time frame: From the beginning of the patient's treatment to 6 months
Radiological progression-free survival
Time from treatment initiation to radiological progression
Time frame: From the beginning of the patient's treatment to 6 months
PSA kinetics curve
The PSA decline curve from the start of ADT, darolutamide, and docetaxel treatment to the completion of docetaxel.
Time frame: Every 3 weeks during the triplet therapy, and every month after treatment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.