International Randomised Study of Prostatectomy vs Stereotactic Body Radiotherapy (SBRT) and Conventionally Fractionated Radiotherapy vs SBRT for Organ-Confined Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,205
- 试验地点
- 75
- 主要终点
- PACE-B and PACE-C: Freedom from biochemical or clinical failure
研究概览
简要总结
This study is an international multicentre randomised study of low, intermediate, and high risk prostate cancer and is composed of three parallel randomisation schemes based on applicability of surgery as a treatment for the patient and risk group. Low and intermediate risk patients, for whom surgery is a consideration, are randomised to either prostatectomy or prostate SBRT. Low and intermediate risk patients, for whom surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Intermediate and high risk patients, for whom ADT treatment is indiacted and surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Efficacy, toxicity and quality of life outcomes will be compared across the pairs in each randomisation.
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
结局指标
主要结局
PACE-B and PACE-C: Freedom from biochemical or clinical failure
时间窗: 5 years from randomisation (primary timepoint)
Biochemical progression is defined as: Phoenix definition Clinical progression is defined as: commencement (PACE-B) or re-commencement (PACE-C) of androgen deprivation therapy, local recurrence, nodal recurrence and distant metastases
PACE-A: Co-primary patient reported outcomes of urinary incontinence and bowel bother
时间窗: 2 years from treatment (primary timepoint)
Urinary incontinence assessed by the number of absorbent pads required per day to control leakage measured by The Expanded Prostate Cancer Index (EPIC) questionnaire. Bowel bother assessed by summary score from the EPIC questionnaire.
次要结局
- All arms: Clinician reported acute toxicity(10 years)
- All arms: Progression-free survival(10 years)
- All arms: Disease-specific and overall survival(10 years)
- All arms: Patient reported acute and late bowel, bladder and erectile dysfunction symptoms.(10 years)
- All arms: Clinician reported late toxicity(10 years)
- PACE-A and PACE-B: Commencement of androgen deprivation therapy; PACE-C: Re-commencement of androgen deprivation therapy(10 years)
- PACE-A: Freedom from biochemical or clinical failure(5 years from randomisation (primary timepoint))