Phase III Randomized Study of Adjuvant Radiotherapy With Versus Without Concurrent Goserelin in Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 743
- 试验地点
- 31
- 主要终点
- Progression-free (biological and/or clinical) survival
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin, may stop the adrenal glands from making androgens. Giving radiation therapy with or without goserelin after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective with or without goserelin in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy and goserelin to see how well they work compared with radiation therapy alone in treating patients who have undergone surgery for recurrent or refractory prostate cancer.
详细描述
OBJECTIVES:
Primary
- Compare the efficacy of adjuvant radiotherapy with vs without concurrent goserelin, in terms of biological and/or clinical progression-free survival, in patients who have undergone surgery for recurrent or refractory prostate cancer.
Secondary
- Compare overall survival of patients treated with these regimens.
- Compare metastases-free survival of patients treated with these regimens.
- Compare the immediate and delayed toxicities of these regimens.
- Compare the delay in reaching the prostate-specific antigen nadir in patients treated with these regimens.
- Compare the quality of life at 1 and 5 years after radiotherapy in these patients.
- Compare the functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over.
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 120 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
I
Exclusive Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
干预措施: adjuvant therapy (Procedure)
I
Exclusive Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
干预措施: radiation therapy (Radiation)
II
Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) and GOSERELIN ACETATE in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
干预措施: goserelin acetate (Drug)
II
Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) and GOSERELIN ACETATE in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
干预措施: adjuvant therapy (Procedure)
II
Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) and GOSERELIN ACETATE in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Progression-free (biological and/or clinical) survival
时间窗: 3.5 years
次要结局
- Immediate and delayed toxicities(not yet evaluable)
- Delay in reaching the prostate-specific antigen nadir(not yet evaluable)
- Quality of life at 1 and 5 years after radiotherapy(not yet evaluable)
- Overall survival(not yet evaluable)
- Metastases-free survival(not yet evaluable)
- Functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over(not yet evaluable)