NCT07126093

High-intensity Focused Ultrasound Combined With Novel Hormone Therapy in Advanced Prostate Cancer

An Exploratory Study on the Application of Focal High-intensity Focused Ultrasound (HIFU) Therapy Combined With Systemic Novel Hormone Therapy in Advanced Prostate Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: Male
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to explore the feasibility and the synergistic anti-cancer effect of high-intensity focused ultrasound (HIFU) combined with novel hormone therapy (NHT) in advanced prostate cancer (PCa). The main questions it aims to answer are: (1) whether could HIFU combined with NHT improve the long-term survival of patients with advanced PCa and alleviate local symptoms? (2) Does the synergistic effect of HIFU combined with NHT exist? Researchers will compare HIFU combined with NHT to NHT alone in advanced PCa patients. Participants will receive HIFU before NHT therapy or only receive NHT. In addition, participants are encouraged to record local symptoms condition and conduct regular follow-up.

Detailed description

An RCT study is conducted to include patients with advanced prostate cancer, who are randomly divided into two groups: the NHT alone group and the HIFU combined with NHT group. We compare the PFS after treatment to explore whether HIFU plus NHT improve the long-term survival and postpone progression. All patients will sign the informed consent form before enrollment and will be taken good care during study period. Patients will be screened according to the inclusion and exclusion criteria and will be given therapy according to randomization. Research data will be analyzed by a professional statistics team. The completion of the research will facilitate the expansion of HIFU into the comprehensive treatment of advanced PCa and will help improve the survival of such patients.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	focal high-intensity focused ultrasound therapy combined with standard novel hormonal therapy	The participants in the intervention arm will receive HIFU combined with standard NHT. Depending on the location of the lesion, tumor load and the pathological conditions, hemicglandular ablation or focal ablation was selectively administered. The safe boundary was set at 3mm, with a power of 300W and a pulse width of 30ms. Novel endocrine therapy was given after HIFU treatment
OTHER	Standard novel hormonal therapy only	Participants in the control arm will receive standard NHT.

Timeline

• Start date: 2025-10-01
• Primary completion: 2029-10-31
• Completion: 2030-10-31
• First posted: 2025-08-17
• Last updated: 2025-08-17