Randomized, Multicenter Study Comparing the Immediate Adjuvant Radiotherapy Associate With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) vs Delayed Radiotherapy Until Biochemical Relapse Associated With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) in Patients With Operable Prostate Cancer pT3 R1 pN0 or pNx at Intermediate Risk.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 424
- 试验地点
- 17
- 主要终点
- Event-free survival
研究概览
简要总结
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as triptorelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving triptorelin and radiation therapy soon after surgery or later after surgery is more effective in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying giving triptorelin and radiation therapy soon after surgery to see how well it works compared with giving them later after surgery in treating patients who have undergone surgery for intermediate-risk stage III or stage IV prostate cancer.
详细描述
OBJECTIVES:
Primary
- Compare the efficacy, in terms of event-free survival at 5 years, of immediate radio-hormonal therapy immediately after prostatectomy for tumor pT2, R1, pN0, or pNx versus radio-hormonal therapy at biochemical relapse.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Compare the metastasis-free survival of these patients.
- Compare the acute and late toxicities of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the functional dependence of patients over 75 years old.
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
A Relapse
Radiotherapy and Hormonotherapy only if relapse
干预措施: triptorelin (Drug)
A Relapse
Radiotherapy and Hormonotherapy only if relapse
干预措施: adjuvant therapy (Procedure)
A Relapse
Radiotherapy and Hormonotherapy only if relapse
干预措施: 3-dimensional conformal radiation therapy (Radiation)
B Immediate treatment
Radiotherapy and Hormonotherapy at randomization
干预措施: triptorelin (Drug)
B Immediate treatment
Radiotherapy and Hormonotherapy at randomization
干预措施: adjuvant therapy (Procedure)
B Immediate treatment
Radiotherapy and Hormonotherapy at randomization
干预措施: 3-dimensional conformal radiation therapy (Radiation)
结局指标
主要结局
Event-free survival
时间窗: From randomization to disease progression or death, up to 5 years
The event-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse (clinical progression, biochemical progression, death)
次要结局
- Acute or chronic toxicity(Throughout study completion, up to 10 years)
- Quality of life questionnaire - Core 30 (QLQ-C30)(At baseline, 2 years, and 5 years)
- Overall survival(From randomization to death from any cause, up to 10 years)
- Metastases-free survival(From randomization to metastases onset, up to 10 years)
- Quality of Life Questionnaire - Prostate Cancer Module (QLQ-PR25)(At baseline, 2 years, and 5 years)
- Functional dependence in patients over 75 years old(At baseline, 2 years, and 5 years)