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

NCT07126093 | Not Yet Recruiting DMC

• 1 other identifier: HIFUNHT20250808
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prostate Cancer

Keywords

prostate cancer; HIFU; NHT

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  PFS refers to the time from the start of randomization to disease progression. Disease progression includes biochemical progression, clinical progression and imaging progression. Biochemical progression is defined as a PSA increase of more than 25% and an absolute increase of 2ng/ml compared to the baseline/minimum value. The definition of clinical progression is the emergence of any new clinical symptoms related to the primary disease and metastases of prostate cancer. The definition of imaging progression in imaging is the appearance of any new metastatic lesions.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 80 months

Secondary Outcomes (2)

• overall survival (OS)

  From date of randomization until the date of death from any cause, assessed up to 80 months

• Time to castration resistance

  the time from the start of randomization to the occurrence of castration resistance, assessed up to 80 months

Study Arms (2)

Combined group

EXPERIMENTAL

Participants in this arm will receive HIFU combined with standard NHT therapy

Combination Product: focal high-intensity focused ultrasound therapy combined with standard novel hormonal therapy

Standard treatment group

OTHER

Participants in this arm will receive standard NHT

Other: Standard novel hormonal therapy only

Interventions

focal high-intensity focused ultrasound therapy combined with standard novel hormonal therapy COMBINATION_PRODUCT

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

Combined group

Standard novel hormonal therapy only OTHER

Participants in the control arm will receive standard NHT.

Standard treatment group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients who are at least 18 years old;
• The physical condition score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 to 2 points.
• Newly diagnosed patients with advanced prostate cancer confirmed by PSMA PET/CT (including metastatic hormone-sensitive prostate cancer or inoperable locally advanced prostate cancer);
• No previous treatments for prostate cancer have been received;
• After assessment, there was no obvious insufficiency of vital organs.
• Sign the written informed consent form for this study, indicating that they fully understand the purpose and process of this study and are willing to participate in it.

You may not qualify if:

• A history of any other active malignant tumor within 2 years (excluding well-treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other carcinoma in situ currently in complete remission);
• Prostate biopsy pathology shows sarcomatoid cells, intraductal carcinoma, and neuroendocrine cell components;
• Accompanied by severe comorbidities, immunosuppression, severe mental illness, severe activity limitation and other conditions that prevent compliance with clinical trials;
• Currently participating in other clinical trials related to this disease;
• According to the researcher's judgment, there are relevant evaluations that do not align with the best interests of the subjects' participation in the study (such as affecting the subjects' sense of happiness) or may hinder, restrict or interfere with the research protocol;
• Concurrent infectious diseases that affect the treatment outcome.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician and assistant resarcher

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 17, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2030
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share