Homoharringtonine Plus Androgen Deprivation Therapy in the Neoadjuvant Treatment of Prostate Cancer: A Single-Arm Clinical Study
Not Applicable
Recruiting
- Conditions
- Prostate Cancer
- Interventions
- Procedure: Radical prostatectomy
- Registration Number
- NCT07163910
- Lead Sponsor
- baotai Liang
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 93
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients with Localized High-Risk/Very High-Risk and Regional Lymph Node-Metastatic Prostate Cancer homoharringtonine 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. Patients with Localized High-Risk/Very High-Risk and Regional Lymph Node-Metastatic Prostate Cancer Radical prostatectomy 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. Patients with metastatic prostate cancer homoharringtonine 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. Patients with metastatic prostate cancer Radical prostatectomy 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.
- Primary Outcome Measures
Name Time Method pCR or MRD rate Within three weeks after the operation PSA response rate 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 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.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Zhongda Hospital
🇨🇳Nanjing, Jiangsu, China
Zhongda Hospital🇨🇳Nanjing, Jiangsu, Chinabaotai liangContact188520698212978793353@qq.com