116
Participants
Start Date
July 30, 2025
Primary Completion Date
June 30, 2026
Study Completion Date
June 30, 2027
Darolutamide , Docetaxel , ADT and Transrectal HIFU Focal Therapy
"Darolutamide , Docetaxel , ADT and Transrectal HIFU Focal Therapy Group:~Darolutamide (600 mg, orally, twice daily) GnRHa (Goserelin 10.8 mg sustained-release implant, subcutaneous injection, every 3 months) Docetaxel (75 mg/m², intravenous infusion, every 3 weeks, for 6 cycles) Dexamethasone (8 mg, orally, 12/3/1 hour before docetaxel infusion)\* Prednisone/Prednisolone (at the investigator's discretion)\* Transrectal High-Intensity Focused Ultrasound (HIFU) for prostate focal therapy (ablation extent determined based on MRI and biopsy findings; number of treatments ≤ 2)~\*Note: Dexamethasone and prednisone/prednisolone are adjunct medications and are not assigned as separate intervention arms; urinary catheter placement is a procedural detail and not listed as an intervention."
RECRUITING
Qilu hospital, Jinan
Qilu Hospital of Shandong University
OTHER