A PHASE III TRIAL OF RADIATION THERAPY WITH OR WITHOUT CASODEX IN PATIENTS WITH PSA ELEVATION FOLLOWING RADICAL PROSTATECTOMY FOR pT3N0 CARCINOMA OF THE PROSTATE
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 840
- 试验地点
- 240
- 主要终点
- Overall Survival (12-year Rates Reported)
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. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 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
Bicalutamide
Radiation therapy + bicalutamide
干预措施: bicalutamide (Drug)
Bicalutamide
Radiation therapy + bicalutamide
干预措施: radiation therapy (Radiation)
Placebo
Radiation therapy + placebo
干预措施: radiation therapy (Radiation)
Placebo
Radiation therapy + placebo
干预措施: placebo (Drug)
结局指标
主要结局
Overall Survival (12-year Rates Reported)
时间窗: From date of randomization to 12 years.
Overall survival rates were estimated by the Kaplan-Meier method, with failure defined as death by any cause. Four-year follow-up was required of all patients, twelve-year rates are reported. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.
次要结局
- Second PSA Recurrence (12-year Rates Reported)(From date of randomization to 12 years.)
- Third PSA Recurrence (12-year Rates Reported)(From start of salvage hormone therapy to 12 years.)
- PSA Complete Response at End of Protocol Treatment(End of protocol treatment, which is planned to last for two years)
- Grade 3+ Toxicity(From date of randomization to four years.)
- Non-Prostate Cancer Death (12-year Rates Reported)(From date of randomization to 12 years.)
- Distant Failure (12-year Rates Reported)(From date of randomization to 12 years.)
- Prostate Cancer Death (12-year Rates Reported)(From date of randomization to 12 years.)
- Progression-free Survival (12-year Rates Reported)(From date of randomization to 12 years.)