Clinical Study of Homoharringtonine Combined With Androgen Deprivation Therapy in Neoadjuvant Treatment of Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- pCR or MRD rate
研究概览
简要总结
The project aims to verify the therapeutic effect of neoadjuvant homoharringtonine combined with androgen deprivation therapy in patients with localized high-risk/very high-risk, regional lymph node-metastatic, or metastatic prostate cancer before radical prostatectomy through clinical trials, thereby identifying an effective treatment for patients with advanced prostate cancer.
详细描述
This study is a single-arm clinical trial, and eligible patients will be enrolled. For the enrolled patients, they will receive an intravenous infusion of homoharringtonine (1 mg) plus an intravenous infusion of 5% glucose injection (250 ml), once daily for two consecutive days. Patients with localized high-risk/very high-risk and regional lymph node-metastatic prostate cancer will receive at least one cycle of the above treatment plus continuous androgen deprivation therapy; patients with metastatic prostate cancer will receive one cycle of treatment, followed by a three-week interval before repeated medication, with the treatment repeated for a total of at least three cycles plus continuous androgen deprivation therapy. All patients will undergo radical prostatectomy within 3 weeks (±7 days) after the end of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patients with Localized High-Risk/Very High-Risk and Regional Lymph Node-Metastatic Prostate Cancer
This study is a single-arm clinical trial, and eligible patients will be enrolled. For the enrolled patients, the treatment regimen will consist of intravenous infusion of 1mg homoharringtonine combined with 250ml of 5% glucose injection, administered once daily for two consecutive days. Patients with localized high-risk/very high-risk prostate cancer or prostate cancer with local lymph node metastasis will receive at least one cycle of the above treatment plus continuous androgen deprivation therapy.All patients will undergo radical prostatectomy within 3 weeks (±7 days) after the completion of treatment.
干预措施: Radical prostatectomy (Procedure)
Patients with Localized High-Risk/Very High-Risk and Regional Lymph Node-Metastatic Prostate Cancer
This study is a single-arm clinical trial, and eligible patients will be enrolled. For the enrolled patients, the treatment regimen will consist of intravenous infusion of 1mg homoharringtonine combined with 250ml of 5% glucose injection, administered once daily for two consecutive days. Patients with localized high-risk/very high-risk prostate cancer or prostate cancer with local lymph node metastasis will receive at least one cycle of the above treatment plus continuous androgen deprivation therapy.All patients will undergo radical prostatectomy within 3 weeks (±7 days) after the completion of treatment.
干预措施: homoharringtonine (Drug)
Patients with metastatic prostate cancer
This study is a single-arm clinical trial, and eligible patients will be enrolled. For the enrolled patients, the treatment will consist of intravenous infusion of 1mg homoharringtonine plus 250ml of 5% glucose injection, administered once daily for two consecutive days. For patients with metastatic prostate cancer, the medication will be repeated after an interval of three weeks following one treatment cycle, with the entire course lasting for at least three cycles, in addition to continuous androgen deprivation therapy. All patients will undergo radical prostatectomy within 3 weeks (±7 days) after the completion of treatment.
干预措施: homoharringtonine (Drug)
Patients with metastatic prostate cancer
This study is a single-arm clinical trial, and eligible patients will be enrolled. For the enrolled patients, the treatment will consist of intravenous infusion of 1mg homoharringtonine plus 250ml of 5% glucose injection, administered once daily for two consecutive days. For patients with metastatic prostate cancer, the medication will be repeated after an interval of three weeks following one treatment cycle, with the entire course lasting for at least three cycles, in addition to continuous androgen deprivation therapy. All patients will undergo radical prostatectomy within 3 weeks (±7 days) after the completion of treatment.
干预措施: Radical prostatectomy (Procedure)
结局指标
主要结局
pCR or MRD rate
时间窗: Within three weeks after the operation
PSA response rate
时间窗: Within one week after the completion of the last treatment cycle (each treatment cycle lasts approximately 25 days)
Biochemical Progression-Free Survival (bPFS) after radical prostatectomy
时间窗: From the date of random grouping to the date when progression was first recorded or the date of any cause of death (whichever comes first), an assessment was conducted for a period of up to 5 years.
次要结局
- Pathological response after radical prostatectomy (including positive surgical margins, tumor size, extraprostatic extension, seminal vesicle invasion, and lymph node involvement)(Within one month after the surgery)
- Changes in radiological TNM staging from post-neoadjuvant therapy to pre-surgery(Within one month after the surgery)
- Safety indicator: CTCAE 5.0 Adverse Event Grading(From the date of random grouping to the date when progression was first recorded or the date of any cause of death, an assessment was conducted for a period of up to 5 years.)
- Quality of life score: EORTC QLQ-C30 scale(From the date of random grouping to the date when progression was first recorded or the date of any cause of death, an assessment was conducted for a period of up to 5 years.)
- Other progression-free survival (progression includes radiological progression, castration resistance, need for further therapeutic intervention, etc.)(From the date of random grouping to the date when progression was first recorded or the date of any cause of death (whichever comes first), an assessment was conducted for a period of up to 5 years.)
研究者
baotai Liang
lead researcher
Zhongda Hospital