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

NCT07172685 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2025-09-15

No results posted yet for this study

Summary

This study is a single-arm prospective cohort study designed to evaluate the efficacy and safety of triple therapy (ADT + darolutamide + docetaxel) combined with transrectal high-intensity focused ultrasound (HIFU) focal therapy in patients with high-tumor-burden metastatic hormone-sensitive prostate cancer (mHSPC).

A total of 116 high-tumor-burden mHSPC patients will be enrolled and are scheduled to receive the following treatment:

Darolutamide + Docetaxel + ADT + Transrectal HIFU Focal Therapy for the Prostate.

Conditions

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.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Principal Investigators

  • Shouzhen Chen, Dr. · Qilu Hospital of Shandong University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-30
Primary Completion
2026-06-30
Completion
2027-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07172685 on ClinicalTrials.gov