A Phase III Study of Neoadjuvant Docetaxel and Androgen Suppression Plus Radiation Therapy Versus Androgen Suppression Alone Plus Radiation Therapy for High-Risk Localized Adenocarcinoma of the Prostate
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 13
- 主要终点
- Disease-free survival
研究概览
简要总结
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, leuprolide, buserelin, and goserelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving androgen suppression therapy together with radiation therapy is more effective with or without docetaxel in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying androgen suppression therapy, radiation therapy, and docetaxel to see how well they work compared with androgen suppression therapy and radiation therapy in treating patients with high-risk localized prostate cancer.
CLOSURE: This trial closed to further accrual in November 2009. The study endpoints will not be reached.
详细描述
OBJECTIVES:
Primary
- To compare disease-free survival rates in patients with high-risk localized adenocarcinoma of the prostate treated with androgen suppression therapy and radiotherapy with vs without docetaxel.
Secondary
- To compare overall survival.
- To compare time to biochemical disease progression.
- To compare time to local disease progression.
- To compare time to distant disease progression.
- To compare time to next anticancer therapy.
- To compare progression-free survival.
- To compare degree of prostate-specific antigen (PSA) suppression prior to radiotherapy.
- To compare quality of life (QOL) using EORTC QLQ C30 and EORTC QLQ PR25 questionnaires and a trial-specific checklist.
- To compare the nature, severity, and frequency of adverse events.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Antiandrogen; LHRH; Radiation Therapy
Antiandrogen (Flutamide or Bicalutamide) LHRH agonist (Eligard)
干预措施: flutamide (Drug)
Antiandrogen; LHRH; Docetaxel, Radiation Therapy
Antiandrogen (Flutamide or Bicalutamide) LHRH agonist (Eligard) Docetaxel
干预措施: bicalutamide (Drug)
Antiandrogen; LHRH; Docetaxel, Radiation Therapy
Antiandrogen (Flutamide or Bicalutamide) LHRH agonist (Eligard) Docetaxel
干预措施: buserelin (Drug)
Antiandrogen; LHRH; Docetaxel, Radiation Therapy
Antiandrogen (Flutamide or Bicalutamide) LHRH agonist (Eligard) Docetaxel
干预措施: flutamide (Drug)
Antiandrogen; LHRH; Docetaxel, Radiation Therapy
Antiandrogen (Flutamide or Bicalutamide) LHRH agonist (Eligard) Docetaxel
干预措施: goserelin (Drug)
Antiandrogen; LHRH; Docetaxel, Radiation Therapy
Antiandrogen (Flutamide or Bicalutamide) LHRH agonist (Eligard) Docetaxel
干预措施: leuprolide acetate (Drug)
Antiandrogen; LHRH; Docetaxel, Radiation Therapy
Antiandrogen (Flutamide or Bicalutamide) LHRH agonist (Eligard) Docetaxel
干预措施: neoadjuvant therapy (Procedure)
Antiandrogen; LHRH; Docetaxel, Radiation Therapy
Antiandrogen (Flutamide or Bicalutamide) LHRH agonist (Eligard) Docetaxel
干预措施: quality-of-life assessment (Procedure)
Antiandrogen; LHRH; Docetaxel, Radiation Therapy
Antiandrogen (Flutamide or Bicalutamide) LHRH agonist (Eligard) Docetaxel
干预措施: radiation therapy (Radiation)
Antiandrogen; LHRH; Docetaxel, Radiation Therapy
Antiandrogen (Flutamide or Bicalutamide) LHRH agonist (Eligard) Docetaxel
干预措施: Docetaxel (Drug)
Antiandrogen; LHRH; Radiation Therapy
Antiandrogen (Flutamide or Bicalutamide) LHRH agonist (Eligard)
干预措施: bicalutamide (Drug)
Antiandrogen; LHRH; Radiation Therapy
Antiandrogen (Flutamide or Bicalutamide) LHRH agonist (Eligard)
干预措施: buserelin (Drug)
Antiandrogen; LHRH; Radiation Therapy
Antiandrogen (Flutamide or Bicalutamide) LHRH agonist (Eligard)
干预措施: goserelin (Drug)
Antiandrogen; LHRH; Radiation Therapy
Antiandrogen (Flutamide or Bicalutamide) LHRH agonist (Eligard)
干预措施: leuprolide acetate (Drug)
Antiandrogen; LHRH; Radiation Therapy
Antiandrogen (Flutamide or Bicalutamide) LHRH agonist (Eligard)
干预措施: neoadjuvant therapy (Procedure)
Antiandrogen; LHRH; Radiation Therapy
Antiandrogen (Flutamide or Bicalutamide) LHRH agonist (Eligard)
干预措施: quality-of-life assessment (Procedure)
Antiandrogen; LHRH; Radiation Therapy
Antiandrogen (Flutamide or Bicalutamide) LHRH agonist (Eligard)
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Disease-free survival
次要结局
- Overall survival
- Time to distant disease progression
- Progression-free survival
- Quality of life
- Time to local disease progression
- Time to biochemical disease progression
- Time to next anti-cancer therapy
- Degree of prostate-specific antigen (PSA) suppression prior to radiotherapy
- Adverse events