5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:A Phase II Study (5STAR-PC)
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Acute Toxicity
研究概览
简要总结
Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.
5-fraction SABR is a feasible, well-tolerated, effective and cost effective treatment for high-intermediate and high risk prostate cancer with/without an image-guided intraprostatic boost.
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
- 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
- •Histologically confirmed prostate adenocarcinoma (centrally reviewed)
- •High-intermediate risk defined as two or more of: T2c, Gleason 7 OR PSA 10-20ng/ml,
- •High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA > 20 ng/mL
- •Willing to give informed consent to participate in this clinical trial
- •Able and willing to complete EPIC, PORPUS and EQ-5D questionnaires
排除标准
- •Prior pelvic radiotherapy
- •Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
- •Anticoagulation medication (if unsafe to discontinue for fiducial insertion)
- •Diagnosis of bleeding diathesis
- •Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >20
- •Evidence of castrate resistance (defined as PSA < 3 ng/ml while testosterone is < 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
- •Definitive extrapelvic nodal or distant metastatic disease on staging investigations.
- •Hip prosthesis
研究组 & 干预措施
Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5
Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.
干预措施: Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5 (Radiation)
结局指标
主要结局
Acute Toxicity
时间窗: Baseline to 3 months post completion of treatment
To document the acute urinary toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria
次要结局
- Quality of life outcome(Baseline to end of 5 year follow up)
- Economic analysis(Baseline to end of 5 year follow up)
- Quality of Life outcome(Baseline to end of 5 year follow up)
- Biochemical disease-free survival(Baseline to end of 5 year follow up)