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Evaluation of the Efficacy of Darolutamide Triplet Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer
Sponsor: Nanfang Hospital, Southern Medical University
Summary
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.
Official title: Prospective Real-world Data Evaluation of Darolutamide (DARO) in Combination With Androgen-deprivation Therapy (ADT) and Docetaxel (DOC) in Patients With Metastatic Hormone-sensitive Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2025-06
Completion Date
2027-06
Last Updated
2025-06-22
Healthy Volunteers
No
Conditions
Interventions
Dose of docetaxel
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