5 Fractions of Pelvic SABR With Intra Prostatic SABR
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- To document the number of patients with grade 3 or higher acute urinary and/or bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria
研究概览
简要总结
Stereotactic Ablative Radiation(SABR) 35 Gy in 5 fractions, once weekly to prostate with simultaneous intraprostatic boost to the MR detected nodule up to 50Gy + 25 Gy in 5 fractions, once weekly simultaneously to seminal vesicles (SV's) and pelvic lymph nodes + 6-18 months of ADT
详细描述
SABR 25Gy / 5 fractions to pelvis; 35Gy / 5 fractions to prostate; up to 50Gy / 5 fractions to MR nodule
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 99 Years（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- tier intermediate risk defined as:
- •PSA 10-20ng/ml AND (T2b-2c OR Gleason 7 )
- •High-risk prostate cancer, defined as at least one of: T3, OR Gleason 8-10, OR PSA > 20 ng/mL
- •Willing to give informed consent to participate in this clinical trial
- •Able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire
排除标准
- •Prior pelvic radiotherapy
- •Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
- •Contraindication to prostate MRI
- •Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- •Diagnosis of bleeding diathesis
- •Large prostate with significant arch interference on TRUS after 3 months of neoadjuvant ADT.
- •Previous TURP
- •Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >20
- •Significant medical co-morbidity rendering patient unsuitable for general anesthetic
- •No 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.
研究组 & 干预措施
Arm 1
Pelvic SABR with intra-prostatic SABR
干预措施: Pelvic SABR with intra-prostatic SABR (Radiation)
结局指标
主要结局
To document the number of patients with grade 3 or higher acute urinary and/or bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria
时间窗: 3 months after accrual target is reached
次要结局
未报告次要终点
研究者
Andrew Loblaw
Principal investigator
Sunnybrook Health Sciences Centre