Evaluation of the Efficacy of Darolutamide Triplet Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer

Not yet recruitingOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

June 30, 2027

Conditions
Metastatic Hormone-sensitive Prostate CancerDarolutamide (DARO) in Combination With Androgen-deprivation Therapy (ADT) and Docetaxel (DOC)
Interventions
DRUG

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

All Listed Sponsors
lead

Nanfang Hospital, Southern Medical University

OTHER