FLAME: Single Blind Randomized Phase III Trial to Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 571
- 试验地点
- 8
- 主要终点
- To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard of care.
研究概览
简要总结
Rationale: Dose escalation in external-beam irradiation has proven to benefit outcome in local prostate cancer. Randomized trials were performed up to doses of 78 Gy in 2 Gy fractions. Nevertheless, the five-year biochemical relapse rate still was approximately 35% in the high-dose arm. Therefore further dose escalation seems to be required. A feasibility study up to appr. 85 Gy on the entire prostate has already been performed and showed acceptable toxicity when combined with adequate position verification. Higher doses to the entire prostate are expected to increase severe toxicity. As local recurrences only occur at the site of the primary macroscopic tumour area the next step in increasing the dose should be an ablative boost to the macroscopic tumour alone, while electively irradiating the rest of the prostate to the current gold standard dose. Feasibility of this approach has been shown for an ablative dose of 95 Gy to the macroscopic tumour within the prostate.
详细描述
Objective:
- Primary study objective: To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard of care.
- Secondary study objectives: Establish and compare the rates of treatment-related toxicity, quality of life and disease-free survival.
Study design: Single blind prospective randomized controlled phase III trial.
Study population: Patients with intermediate or high risk adenocarcinoma of the prostate. Intermediate or high risk is defined according to the Ash et al. 2000 criteria as:
- One (intermediate-risk) or more (high-risk) factors: T2, or Gleasonscore=7, or iPSA 10-20 ng/mL
- One or more (high-risk) factors: T3, or Gleasonscore >7, or iPSA >20 ng/mL
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
- Single (Participant)
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
- •Prostate cancer patients scheduled for external beam radiotherapy using IMRT and fiducial marker-based position verification
- •Intermediate and high risk prostate cancer, defined by Ash et al. 2000, namely:
- •One or more factors: T2, or Gleasonscore >7, or iPSA > 10 ng/mL
- •WHO score 0-2
排除标准
- •Low risk prostate cancer, defined by Ash et al. 2000
- •World Heath Organisation (WHO) score >2
- •International Prostate Symptom Score (IPSS) >20
- •If for any patient related reason an MRI cannot be performed
- •If anticoagulation cannot be stopped temporarily regarding the implant of fiducial markers
- •Previous prostatectomy (except from Trans Urethral Prostatectomy (TURP))
- •TURP within 3 months from start treatment
- •Previous pelvic irradiation
结局指标
主要结局
To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard of care.
时间窗: Every six months for 10 years
PSA relapse is defined by the Phoenix definition (2005) as nadir +2ng/ml.
次要结局
- Establish and compare the rates of treatment-related toxicity.(Every six months until 10 years)
- Disease specific survival(every 6 montths until 10 years)
- quality of life(every six months until 10 year)
研究者
L.G.W. Kerkmeijer
L.G.W. Kerkmeijer, MD, PhD
UMC Utrecht