Safety and Efficacy of Docetaxel, Darolutamide, and Homoharringtonine Combined With Androgen Deprivation Therapy in Neoadjuvant Treatment of High-Risk Prostate Cancer: A Multicenter Prospective, Single-Arm Clinical Study

Обзор

Previous study findings suggest that the efficacy limitations of the neoadjuvant treatment regimen combining docetaxel with androgen deprivation therapy are associated with protein synthesis. Homoharringtonine (HHT) is currently the only small-molecule translation elongation inhibitor approved by the U.S. Food and Drug Administration (FDA). Building on this foundation, we plan to conduct a prospective interventional study aimed at validating whether the intensified quadruple regimen, formed by adding darolutamide and homoharringtonine (HHT) to the standard regimen, can further significantly enhance the depth of pathological response and improve patient outcomes through multi-mechanism synergy.

Вмешательства

• Препарат Docetaxel+ Darolutamide + Homoharringtonine+ Androgen Deprivation Therapy
  \*\*Docetaxel:\*\* 75 mg/m², intravenous infusion, once every 3 weeks (administered in weeks 1, 4, and 7), for a total of 3 cycles. To prevent allergic reactions and fluid retention, oral dexamethasone 8 mg is administered twice daily on the day before, the day of, and the day after docetaxel infusion. \*\*Darolutamide:\*\* 600 mg, orally, twice daily, starting from day 1 of treatment and continued until 1 week before surgery. To be taken with food. \*\*Homoharringtonine:\*\* 1 mg of homoharr

Первичные конечные точки

• pCR or MRD Rate [Срок оценки: 1 month after surgery]
• PSA response rate [Срок оценки: Defined as the comparison of PSA levels before neoadjuvant therapy and at the end of the neoadjuvant therapy cycle (before surgery).]
• iochemical Progression-Free Survival (bPFS) after Radical Prostatectomy [Срок оценки: 1 month after surgery]

Вторичные конечные точки (5)

• Pathological response after radical prostatectomy [Срок оценки: 1 month after surgery]
• TNM stage [Срок оценки: 1 month after surgery]
• Other PFS [Срок оценки: 1 month after surgery]
• Safety indicator: CTCAE 5.0 adverse event grading [Срок оценки: 1 month after surgery]
• Quality of life score: EORTC QLQ-C30 questionnaire [Срок оценки: 1 month after surgery]

Критерии участия

Критерии включения

• ① Age ≥ 18 years and ≤ 85 years;

• Histologically or cytologically confirmed prostate cancer;

• High-risk prostate cancer: meeting at least one of the following criteria: clinical stage T3-T4, or Gleason score 8-10, or PSA > 20 ng/mL, or presence of distant metastasis (clinical stage M1); ④ ECOG (Eastern Cooperative Oncology Group) performance status score of 0-1; ⑤ All patients voluntarily sign informed consent and are able to adhere to treatment and follow-up

Критерии исключения

• ① Any prior or ongoing treatment for prostate cancer, including radiotherapy, chemotherapy, ADT, etc.;

• Previous prostatectomy; ③ Any other serious underlying medical, psychiatric, or psychological conditions that, in the investigator's judgment, may affect treatment;

• Allergy to any of the study drugs; ⑤ Refusal to undergo radical prostatectomy; ⑥ Deemed unsuitable for participation in this clinical trial by the investigator's judgment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07516704 · 2026ZDSYLL031-P01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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