Androgen Deprivation Withdrawal Versus Maintenance and Intermittent Chemotherapy Versus Continuous in Prostate Cancer Patients With Castrate Resistant Disease
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 600
- 试验地点
- 32
- 主要终点
- overall survival
研究概览
简要总结
The study includes the recruitment of patients with advanced prostate cancer resistant to chemical castration This is a multicenter prospective trial randomized phase III
详细描述
The study includes the recruitment of patients with advanced prostate cancer resistant to chemical castration This is a multicenter prospective trial randomized phase III This study design that includes a double randomizzzazione aims generally demonstrating non-inferiority in terms of survival of the suspension dell'ormonoterapia versus the maintenance and / or administration of intermittent versus continuous administration of chemotherapy in patients with prostate cancer resistant to chemical castration I started to line chemotherapy with Docetaxel.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age over 18 years,
- •histologically documented adenocarcinoma of the prostate,
- •written informed consent to the study,
- •Castrate resistant metastatic prostate cancer in the presence of castrate levels of testosterone (<50 ng/ml) and eligible to docetaxel chemotherapy. The condition of castrate resistant prostate cancer is the defined either as the documentation of a new metastasis or PSA increase more than 50% or increase more than 25% from a lower PSA value during previous hormone therapy in case of disease response or stabilization to previous hormone therapy, respectively. Absolute PSA increase should be greater than 5 ng/ml,
- •an elevated PSA level must have been documented within 4 weeks of initiating docetaxel chemotherapy,
- •more than 4 weeks since major surgery and fully recovered,
- •more than 4 weeks since any prior radiation with any toxicity attributable to radiation resolved to grade 1 or less,
- •more than 8 weeks since the last dose of strontium or samarium,
- •ECOG Performance Status more than/equal to 2,
- •life expectancy >6 months,
- •required initial laboratory values: absolute neutrophil count > 1500/ul Platelets > 100,000/ul., Hemoglobin > 8.0 g/dl, Creatinine, SGOT, SGPT less than 2.0 X upper limit of normal, Bilirubin less than/equal to upper limit of normal (ULN).
- •Appropriate patient compliance
排除标准
- •Patients with increased serum PSA levels with negative bone scan and CT scan.
- •Prior systemic chemotherapy for prostate cancer. Prior neoadjuvant or adjuvant chemotherapy is permitted if there was no evidence of disease relapse within 12 months of the last dose of chemotherapy,
- •Peripheral neuropathy >grade 1,
- •myocardial infarction or significant change in anginal pattern within the last 6 months, symptomatic congestive heart failure (NYHA Class III or higher) or uncontrolled cardiac arrhythmia,
- •patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80,
- •poorly controlled diabetes (fasting blood glucose >250) despite optimization of medical therapy, peptic ulcers or other contraindications to steroid therapy,
- •previous history of malignant disease with the exception of non melanoma skin cancer curatively treated,
- •significant neurologic or psychiatric diseases preventing patients to give a valid informed consent,
- •brain metastases,
- •prisoner status
- •because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded.
研究组 & 干预措施
Treatment arm
ten docetaxel cycles + maintenance androgen deprivation.
干预措施: Docetaxel + LH-RH analogues (Drug)
suspension arm
Ten Docetaxel cycles + stop androgen deprivation therapy
干预措施: Docetaxel (Drug)
intermittent arm
Intermittent Docetaxel
干预措施: Docetaxel (Drug)
Continuous arm
Continuous Docetaxel
干预措施: Continuous Docetaxel (Drug)
结局指标
主要结局
overall survival
时间窗: six years
The primary aim of the study will be the demonstration of non inferiority in terms of overall survival of stopping androgen deprivation therapy (arm B) versus maintenance androgen deprivation therapy (arms A) and intermittent docetaxel therapy (arm AB1) versus continuous docetaxel therapy (arms AB2) up to ten cycles.
次要结局
- Toxicity(six years)
- Progression free survival(six years)
- Quality of life(six years)
- Pain(six years)
- Cost Analysis(six years)