A Prospective Multi-center Study to Compare the QOL and Efficacy of Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer.
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Median biochemical progression-free survival
研究概览
简要总结
This trial is going to evaluate tumor control and quality of life in patients with prostate cancer treated with endocrine therapy with or without cryoablation.
详细描述
OBJECTIVES:
- To determine the tumor control in patients with prostate cancer treated with radiotherapy or cryoablation
- To determine the quality of life of these patients. OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≥ 8 vs 7 vs ≤ 6), persistent prostatic specific antigen (PSA) at allocation (> 0.5 ng/mL vs ≤ 0.5 ng/mL), participating center. Patient are allocated to two treatment arms.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate adenocarcinoma, T4N0M0, Any T with N+ or M+
- •Previously untreated disease or undergone endocrine therapy without reaching to castration resistant prostate cancer
- •Survival ≥ 12 months
- •WHO performance status 0-2
- •white blood cell ≥ 3.5 ×10*9/L
- •Platelets ≥ 5×10*9/L
- •Hemoglobin ≥ 10 g/dL
排除标准
- •History of malignant disease
- •History of coronary artery disease
- •Uncontrolled infection
- •Other concurrent severe or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes mellitus, uncontrolled cardiac disease, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within the past six months, chronic liver or renal disease, and active upper gastrointestinal tract ulceration)
- •Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study treatment and follow-up schedule
研究组 & 干预措施
Arm1
Patients receive oral bicalutamide once daily on days 1-28. Patients also receive luteinizing-hormone releasing-hormone (LHRH) agonist treatment intramuscularly (IM) on day 8. Treatment with LHRH agonist repeats every 12 weeks for 24 weeks.
Patients receive cryoablation therapy.
干预措施: cryoablation (Procedure)
Arm1
Patients receive oral bicalutamide once daily on days 1-28. Patients also receive luteinizing-hormone releasing-hormone (LHRH) agonist treatment intramuscularly (IM) on day 8. Treatment with LHRH agonist repeats every 12 weeks for 24 weeks.
Patients receive cryoablation therapy.
干预措施: Bicalutamide (Drug)
Arm1
Patients receive oral bicalutamide once daily on days 1-28. Patients also receive luteinizing-hormone releasing-hormone (LHRH) agonist treatment intramuscularly (IM) on day 8. Treatment with LHRH agonist repeats every 12 weeks for 24 weeks.
Patients receive cryoablation therapy.
干预措施: luteinizing-hormone releasing-hormone (LHRH) agonist (Drug)
Arm2
Patients receive oral bicalutamide once daily on days 1-28. Patients also receive luteinizing-hormone releasing-hormone (LHRH) agonist treatment intramuscularly (IM) on day 8. Treatment with LHRH agonist repeats every 12 weeks for 24 weeks.
干预措施: Bicalutamide (Drug)
Arm2
Patients receive oral bicalutamide once daily on days 1-28. Patients also receive luteinizing-hormone releasing-hormone (LHRH) agonist treatment intramuscularly (IM) on day 8. Treatment with LHRH agonist repeats every 12 weeks for 24 weeks.
干预措施: luteinizing-hormone releasing-hormone (LHRH) agonist (Drug)
结局指标
主要结局
Median biochemical progression-free survival
时间窗: Within 12 months after treatment
It measures the time to biochemical progression (PSA progression).
Quality of Life impact of treatments' side effects measured by change in EORTC QOL-C30 from baseline to 3, 6 and 12 months after treatment
时间窗: 3, 6 and 12 months after treatment
European Organization for Research and Treatment of Cancer(EORTC)
次要结局
- Disease Specific Survival(5 year)
- Overall survival(5 year)