Radiotherapy - Adjuvant Versus Early Salvage. A Phase III Multi-centre Randomised Trial Comparing Adjuvant Radiotherapy (RT) With Early Salvage RT in Patients With Positive Margins or Extraprostatic Disease Following Radical Prostatectomy.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 333
- 试验地点
- 68
- 主要终点
- Biochemical failure: PSA ≥ 0.4 ng/ml and rising following RT
研究概览
简要总结
Radical prostatectomy (RP) is the most common curative approach offered to men with newly diagnosed prostate cancer. Unfortunately, up to half of these patients will have factors placing them at high risk of their cancer recurring. Having radiotherapy after RP is known to improve cure rates, but what is not known is whether it should be given straight after the operation or only when there is a rising PSA after surgery indicating active cancer. Immediate RT may not benefit all men, and can cause serious side effects such as bladder and bowel problems and impotence. International lack of consensus on the optimal timing of RT has resulted in varied clinical practice. This phase 3 trial will compare the two approaches.
详细描述
This is a prospective, multi-centre, international, randomised controlled trial with a 1:1 allocation ratio. Patients with positive margins and/or pT3 disease will be randomised to adjuvant RT (Standard Arm) or active surveillance with salvage RT delivered at early relapse (Experimental Arm). 64 Gy in 32 fractions will be delivered to the prostate bed. QoL self-assessment questionnaires, Hospital Anxiety and Depression Score and toxicity will be assessed at baseline, the end of RT and annually for 5 years. Patients will be seen by their doctor 6 monthly for the first 5 years, then annually for the next 5 years. A blood test measuring prostate specific antigen (PSA) is done 3 monthly for the first 5 years for patients randomised to early salvage RT, then 6 monthly from years 5 to 10.
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
- •Prior Radical Prostatectomy (RP) for adenocarcinoma of the prostate.
- •Histological confirmation of adenocarcinoma of the prostate with the Gleason score reported (Radical Prostatectomy specimen).
- •Patients must have at least one of the following risk factors: 1) Positive margins, 2) Extraprostatic extension (EPE) with or without seminal vesicle involvement (pT3a or pT3b)
- •Capable of starting RT within 4 months of RP (a requirement if randomised to adjuvant RT arm)
- •Most recent PSA ≤ 0.10 ng/ml following RP and prior to randomisation
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
- •Patient able to adhere to the specified follow-up schedule and complete the Quality of Life and anxiety/depression self-assessments
- •Written informed consent obtained prior to randomisation
- •Completion of all pre-treatment evaluations
- •18 years and older
排除标准
- •Previous pelvic RT
- •Androgen deprivation (AD) prior to or following RP
- •Evidence of nodal or distant metastases
- •Co-morbidities that would interfere with the completion of treatment and/or 5 years of follow-up
- •Concurrent cytotoxic medication
- •Hip prosthesis
结局指标
主要结局
Biochemical failure: PSA ≥ 0.4 ng/ml and rising following RT
时间窗: After 160 events have been observed, expected to be 5 years after recruitment closes
次要结局
- Toxicity(Final analysis will be after 160 events, estimated to be 5 years after end of accrual.)
- Quality of Life(Final Analysis will be after 160 events, estimated to be five years after the end of accrual)
- Overall survival(Final analysis will be after 160 events, estimated to be 5 years after end of accrual.)
- Time to distant failure(Final analysis will be after 160 events, estimated to be 5 years after end of accrual.)
- Time to the initiation of androgen ablation(Final analysis will be after 160 events, estimated to be 5 years after end of accrual.)
- Anxiety/Depression(Final analysis will be after 160 events, estimated to be 5 years after end of accrual.)
- Biochemical failure-free survival(Final analysis will be after 160 events, estimated to be 5 years after end of accrual.)
- Cost-utility(Final analysis will be after 160 events, estimated to be 5 years after end of accrual.)
- Disease-specific survival(Final analysis will be after 160 events, estimated to be 5 years after end of accrual.)
- Quality adjusted life years(Final analysis will be after 160 events, estimated to be 5 years after end of accrual.)
- Time to local failure(Final analysis will be after 160 events, estimated to be 5 years after end of accrual.)