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NOT YET RECRUITING
NCT07126093
NA

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

Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

134

Start Date

2025-10-01

Completion Date

2030-10-31

Last Updated

2025-08-17

Healthy Volunteers

No

Conditions

Interventions

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.