Phase III Multicenter Randomized Trial of Adjuvant Androgen Deprivation in Combination With Three-dimensional Conformal Radiotherapy Doses in High and Intermediate Risk Localized Prostate Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 362
- 试验地点
- 1
- 主要终点
- Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years
研究概览
简要总结
The present study is a phase III randomized and multicentric trial evaluating the potential additional impact effect of two years adjuvant androgen deprivation when combined with neoadjuvant (4 months) and high-dose (76 Gy) conformal radiotherapy in moderate high-risk prostate cancer patients. Stratification will be performed by prognostic factors and by participating institution.
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
- •Histological proven adenocarcinoma of the prostate
- •Stage: cT1c-3b N0M0 according to American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM)
- •Prostatic Specific Antigen (PSA)<100 ng/ml
- •Intermediate (T1-T2 with Gleason Score [GS] 7 and/or PSA 10-20)
- •High risk (T3 and/or GS 8-10 and/or PSA > 20)
- •Karnofsky Index (KI) performance status ≥70%
- •Written informed consent
排除标准
- •T4 N1 M1,
- •Previous surgical treatment (prostatectomy or cryosurgery)
- •Neoadjuvant hormonal treatment > 3 months.
- •History of pelvic radiotherapy (RT)
- •Contraindications for radiotherapy
- •Concomitant use of chemotherapy
- •Serious psychiatric or medical condition
- •Current synchronic malignancies
研究组 & 干预措施
Long term androgen deprivation
- Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
- Bicalutamide 50 mg tablet every day for 2 months
- High dose conformal radiotherapy
- Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy
干预措施: Long term androgen deprivation (Radiation)
Short term androgen deprivation
- Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
- Bicalutamide 50 mg tablet every day for 2 months
- High dose conformal radiotherapy
干预措施: Short term androgen deprivation (Radiation)
结局指标
主要结局
Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years
时间窗: 5 years
Biochemical relapse was defined as the time from inclusion in the study (randomization) until the patient meets criteria for Biochemical failure (Phoenix criteria: PSA nadir plus 2 ng/ml).
次要结局
- Late Toxicity(5 years)
- Overall Survival: Estimated Percentage of Participants Alive at 5 Years(5 years)
- Cause-specific Survival(5 years)
- Metastasis Free Survival: Estimated Percentage of Participants With Metastasis-free Survival at 5 Years(5 years)