A PHASE III TRIAL COMPARING WHOLE PELVIC IRRADIATION FOLLOWED BY A CONEDOWN BOOST TO BOOST IRRADIATION ONLY AND COMPARING NEOADJUVANT TO ADJUVANT TOTAL ANDROGEN SUPPRESSION (TAS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,322
- 主要终点
- Progression-free survival (Arms 1, 3 vs. Arms 2, 4)
研究概览
简要总结
RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Hormone therapy combined with radiation therapy may be a more effective treatment for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of four different combinations of radiation and hormone therapy in treating patients with prostate cancer.
详细描述
OBJECTIVES: I. Examine whether total androgen suppression (TAS) with flutamide/goserelin and whole-pelvic irradiation followed by a cone-down boost to the prostate improves progression-free survival at 5 years by at least 10% compared to TAS and prostate-only irradiation in patients with adenocarcinoma of the prostate at significant risk of nodal involvement. II. Examine whether induction and concurrent (neoadjuvant) TAS and radiotherapy improves the progression-free survival at 5 years by at least 10% compared to adjuvant TAS and radiotherapy. III. Compare treatments with regard to local control, time to distant failure, and overall survival.
OUTLINE: Randomized study. Arm I: Neoadjuvant Antiandrogen Therapy with Radiotherapy. Flutamide, FLUT, NSC-147834; Goserelin, Zoladex, ZDX, NSC-606864; with irradiation of the whole pelvis followed by a boost to the prostate using photons of at least 6 MV. Arm II: Neoadjuvant Antiandrogen Therapy with Radiotherapy; FLUT; ZDX; with irradiation of the prostate using equipment as in Arm I. Arm III: Radiotherapy followed by Adjuvant Antiandrogen Therapy. Irradiation as in Arm I; followed by FLUT; ZDX. Arm IV: Radiotherapy followed by Adjuvant Antiandrogen Therapy. Irradiation as in Arm II; followed by FLUT; ZDX.
PROJECTED ACCRUAL: 1,200 patients will be accrued over 2.5 years.
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
- — 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
Arm 1
Neoadjuvant total androgen suppression (TAS) given 2 months before and during radiation therapy (RT) to the whole pelvis followed by a prostate boost.
干预措施: flutamide (Drug)
Arm 1
Neoadjuvant total androgen suppression (TAS) given 2 months before and during radiation therapy (RT) to the whole pelvis followed by a prostate boost.
干预措施: goserelin acetate (Drug)
Arm 1
Neoadjuvant total androgen suppression (TAS) given 2 months before and during radiation therapy (RT) to the whole pelvis followed by a prostate boost.
干预措施: low-LET photon therapy (Radiation)
Arm 2
Neoadjuvant TAS given 2 months before and during RT to the prostate only.
干预措施: flutamide (Drug)
Arm 2
Neoadjuvant TAS given 2 months before and during RT to the prostate only.
干预措施: goserelin acetate (Drug)
Arm 2
Neoadjuvant TAS given 2 months before and during RT to the prostate only.
干预措施: low-LET photon therapy (Radiation)
Arm 3
RT to the whole pelvis followed by a boost to the prostate followed by 4 months of TAS.
干预措施: flutamide (Drug)
Arm 3
RT to the whole pelvis followed by a boost to the prostate followed by 4 months of TAS.
干预措施: goserelin acetate (Drug)
Arm 3
RT to the whole pelvis followed by a boost to the prostate followed by 4 months of TAS.
干预措施: low-LET photon therapy (Radiation)
Arm 4
RT to the prostate only followed by 4 months of TAS.
干预措施: flutamide (Drug)
Arm 4
RT to the prostate only followed by 4 months of TAS.
干预措施: goserelin acetate (Drug)
Arm 4
RT to the prostate only followed by 4 months of TAS.
干预措施: low-LET photon therapy (Radiation)
结局指标
主要结局
Progression-free survival (Arms 1, 3 vs. Arms 2, 4)
时间窗: From randomization to the first occurrence of biochemical failure, clinical failure (local or distant), death from any cause, or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.
次要结局
- Local progression(From randomization to the date of local progression or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.)
- Progression-free survival (Arms 1, 2 vs. Arms 3, 4)(From randomization to the first occurrence of biochemical failure, clinical failure (local or distant), death from any cause, or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.)
- Overall survival(From the date of randomization to the date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.)
- Distant metastasis(From randomization to the date of metastatic disease or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.)