Stereotactic Prostate Augmented Radiotherapy With Cyberknife
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Acute genitourinary(GU) toxicity
研究概览
简要总结
Giving a higher dose of radiation to the dominant tumour nodule within the prostate is hypothesized to improve tumour control. This trial will assess whether this technique, delivered in 5 treatments, can be delivered without increasing side effects.
详细描述
Aim To assess if a focal boost can be delivered to the dominant tumour nodule alongside 36.25 Gy in 5 fractions to the whole prostate gland.
Primary end-point: Acute toxicity (Radiation Therapy Oncology Group (RTOG), International prostate symptom score (IPSS))
Secondary end-points: Prostate specific antigen (PSA) nadir and 2-year biochemical control Late toxicity (IPSS, RTOG, International index of erectile function (IIEF-5)) Quality of life (EQ5D scale)
Inclusion criteria
- Prostate cancer patients with any of the following:
- PSA>20
- Gleason grade 4+3 or higher
- Stage T3a
- Exclusion criteria
- Nodal or metastatic disease
- PSA>40
- Stage T3b or higher
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer patients with any of the following:
- •PSA 20-40
- •Gleason grade 4+3 or higher
- •Stage T3a
排除标准
- •Nodal or metastatic disease
- •Stage T3b or higher
结局指标
主要结局
Acute genitourinary(GU) toxicity
时间窗: Maximal recorded toxicity within the acute toxicity period (up to 12 weeks)
RTOG scale acute GU toxicity will be measured at baseline, end of treatment, then 2,4 and 12 weeks post treatment. The maximal toxicity during follow up is the primary outcome measure.
次要结局
- Acute gastrointestinal (GI) toxicity(Within 12 weeks of treatment completion)
- Late GI and GU toxicity(From 12 weeks until study completion)
- Patient reported outcomes i.e. IPSS, IIEF-5 and EQ5-D(Baseline, 12 weeks, 12 months and 6 monthly to 5 years)
- Biochemical relapse-free survival(Measured at 12 weeks after completion of treatment and 3-6 monthly to 5 years thereafter)