Phase III Randomized Study of Adjuvant Therapy for High Risk pT3N0 Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Drugs such as, flutamide or bicalutamide may stop the adrenal glands from producing androgens. Giving radiation therapy with hormone therapy after surgery to remove the tumor may kill any tumor cells remaining after surgery and be an effective treatment for stage II or stage III prostate cancer. It is not yet known if radiation therapy combined with hormone therapy is more effective than either radiation therapy alone or hormone therapy alone in treating stage II or stage III prostate cancer. (Hormone therapy alone group closed as of 12/9/2002.)
PURPOSE: Randomized phase III trial to compare the effectiveness of adjuvant radiation therapy plus hormone therapy to that of radiation therapy alone or hormone therapy alone in treating patients who have stage II or stage III prostate cancer.
详细描述
OBJECTIVES:
- Compare the overall survival, disease-free survival, freedom from distant metastases, and freedom from PSA failure in patients with high-risk stage II or III prostate cancer treated in the adjuvant setting with radiotherapy and hormonal therapy vs radiotherapy alone.
- Compare the qualitative and quantitative toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to seminal vesicle invasion (yes vs no), preoperative PSA (10 ng/mL or less vs greater than 10 ng/mL), Gleason score (2-6 vs 7 vs 8-10), positive surgical margins (yes vs no), and neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 3 treatment arms. (Arm III closed to accrual as of 12/9/2002.)
- Arm I: Patients undergo radiotherapy once daily 5 days a week for 7 weeks. Beginning the first day of radiotherapy, patients also receive hormonal therapy comprising a luteinizing-hormone-releasing hormone agonist once every 1-4 months for 2 years AND oral flutamide 3 times daily OR oral bicalutamide once daily for 1 month.
- Arm II: Patients undergo radiotherapy as in arm I.
- Arm III (Closed to accrual as of 12/9/2002):Patients receive hormonal therapy as in arm I.
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.
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
- 0 Years 至 120 Years（Child, 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
Radiation therapy alone
Radiation therapy alone to 63.0 - 66.6 Gy
干预措施: adjuvant therapy (Procedure)
LH-RH agonist plus radiation therapy
Luteinizing hormone-releasing hormone (LH-RH) agonist x 2 years plus radiation therapy (RT) to 63.0 - 66.6 Gy
干预措施: bicalutamide (Drug)
LH-RH agonist plus radiation therapy
Luteinizing hormone-releasing hormone (LH-RH) agonist x 2 years plus radiation therapy (RT) to 63.0 - 66.6 Gy
干预措施: flutamide (Drug)
LH-RH agonist plus radiation therapy
Luteinizing hormone-releasing hormone (LH-RH) agonist x 2 years plus radiation therapy (RT) to 63.0 - 66.6 Gy
干预措施: releasing hormone agonist therapy (Drug)
LH-RH agonist plus radiation therapy
Luteinizing hormone-releasing hormone (LH-RH) agonist x 2 years plus radiation therapy (RT) to 63.0 - 66.6 Gy
干预措施: adjuvant therapy (Procedure)
LH-RH agonist plus radiation therapy
Luteinizing hormone-releasing hormone (LH-RH) agonist x 2 years plus radiation therapy (RT) to 63.0 - 66.6 Gy
干预措施: radiation therapy (Radiation)
Radiation therapy alone
Radiation therapy alone to 63.0 - 66.6 Gy
干预措施: radiation therapy (Radiation)
LH-RH agonist alone
Luteinizing hormone-releasing hormone (LH-RH) agonist x 2 years
干预措施: bicalutamide (Drug)
LH-RH agonist alone
Luteinizing hormone-releasing hormone (LH-RH) agonist x 2 years
干预措施: flutamide (Drug)
LH-RH agonist alone
Luteinizing hormone-releasing hormone (LH-RH) agonist x 2 years
干预措施: releasing hormone agonist therapy (Drug)
LH-RH agonist alone
Luteinizing hormone-releasing hormone (LH-RH) agonist x 2 years
干预措施: adjuvant therapy (Procedure)
结局指标
主要结局
Overall survival
时间窗: From the date of randomization to the date of death due to any cause
次要结局
- Disease-Free Survival(From the date of randomization to the date of first documented local progression or distant failure)
- Distant Failure(From the date of randomization to the date of frist documented metastatic disease)
- Biochemical Failure (detectable PSA)(From the date of randomization to the date of developing a PSA of 0.5 ng/ml or greater over the entry PSA)