RecruitingInterventionalNot ApplicableLast updated Sep 15, 2025

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

Exploratory Study on the Efficacy and Safety of Triple Therapy (ADT + Darolutamide + Docetaxel Chemotherapy) Combined With Transrectal High-Intensity Focused Ultrasound Focal Therapy in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) With High Tumor Burden

Overview

ClinicalTrials.gov ID: NCT07172685
Lead Sponsor: Qilu Hospital of Shandong UniversityOTHER
Brief 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.

Status

Overall Status: Recruiting
Start Date: Jul 30, 2025Actual
Primary Completion Date: Jun 30, 2026Estimated
Completion Date: Jun 30, 2027Estimated

Study Record Dates

First Submitted: Aug 26, 2025
First Submitted that Met QC Criteria: Sep 7, 2025
First Posted: Sep 15, 2025Actual
Last Update Submitted that Met QC Criteria: Sep 7, 2025
Last Update Posted: Sep 15, 2025Actual
Last Verified: Jul 2025

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