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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Комбинированный продукт 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
• Другое Standard novel hormonal therapy only
  Participants in the control arm will receive standard NHT.

Первичные конечные точки

• progression-free survival (PFS) [Срок оценки: 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]

Вторичные конечные точки (2)

• overall survival (OS) [Срок оценки: From date of randomization until the date of death from any cause, assessed up to 80 months]
• Time to castration resistance [Срок оценки: the time from the start of randomization to the occurrence of castration resistance, assessed up to 80 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07126093 · HIFUNHT20250808

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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