Study on Triple Therapy Combined With HIFU for High-Tumor-Burden mHSPC

NARecruitingINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

July 30, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2027

Conditions
Prostate Cancer
Interventions
COMBINATION_PRODUCT

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."

Trial Locations (1)

276600

RECRUITING

Qilu hospital, Jinan

All Listed Sponsors
lead

Qilu Hospital of Shandong University

OTHER

NCT07172685 - Study on Triple Therapy Combined With HIFU for High-Tumor-Burden mHSPC | Biotech Hunter | Biotech Hunter