Phase III Study of Adaptive Stereostactic Body Radiotherapy With Dose-escalation on the Dominant Intraprostatic Lesion for High-risk Prostate Cancer: ORION Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- Efficacy of adaptive prostate Stereostatic Body RadioTherapy (SBRT) integrating both Whole Pelvic RadioTherapy (WPRT) and dose-escalation on the Dominant Intraprostatic Lesion (DIL)
研究概览
简要总结
The aim of this clinical trial is to evaluate the efficacy of adaptive prostate Stereotatic Body RadioTherapy (SBRT), which integrates both Whole Pelvic RadioTherapy (WPRT) and dose escalation on the Dominant Intraprostatic Lesion (DIL), compared with standard radiotherapy. This will be assessed using a 5-year cost-utility analysis based on data from the clinical trial and the National Health Data System (NHDS).
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
- •Age ≥ 18 years
- •ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- •Histologically proven prostate adenocarcinoma, not previously treated
- •High-risk or very high-risk according to the National Comprehensive Cancer Network (NCCN) :
- •T3a / T3b (proximal extension only),
- •and/or ISUP (International Society of Urological Pathology) grade 4-5,
- •and/or PSA (Prostate-Specific Antigen) 20ng/mL
- •Non-metastatic, as proven by Prostate Specific Membrane Antigen (PSMA) positron emission tomography/computed tomography (PET/CT) and pelvic MRI (Magnetic Resonance Imaging) less than 2 months before starting hormone therapy
- •Normal testosterone levels prior to hormone therapy
- •Ability to give consent for inclusion in the study
- •Acceptance of treatment and monitoring modalities
排除标准
- •Presence of nodal or distant metastases
- •Prostate volume > 80 cm
- •IPSS >19/
- •Previous local treatment of prostate adenocarcinoma (HIFU (High-Intensity Focused Ultrasound), cryotherapy)
- •Previous TransUrethral Resection of the prostate (PTUR)).
- •Previous pelvic radiotherapy.
- •Chronic inflammatory bowel disease.
- •Active cardiovascular comorbidities (e.g. myocardial infarction or ischemic stroke within the last 6 months).
研究组 & 干预措施
innovative arm
Participants treated with Stereostatic Body RadioTherapy (SBRT) will be administered an adaptative stereostactic, ultra-fractionated radiotherapy every other day, for a total treatment time of 10 days. Total treatment time should not exceed 17 days
干预措施: Adaptive Stereostatic Body RadioTherapy (SBRT) including both Whole Pelvic RadioTherapy (WPRT) and dose-escalation on the Dominant Intraprostatic Lesion (DIL) (Procedure)
control arm
Patients will be treated by Conventional fractionation in 39 fractions, 5 days a week or Moderate hypofractionation in 20 fractions , 5 days a week
干预措施: conventional or a moderately hypofractionated (Procedure)
结局指标
主要结局
Efficacy of adaptive prostate Stereostatic Body RadioTherapy (SBRT) integrating both Whole Pelvic RadioTherapy (WPRT) and dose-escalation on the Dominant Intraprostatic Lesion (DIL)
时间窗: Five years after radiotherapy
The primary endpoint is incremental cost effectiveness ratio (ICER) expressed as the cost for each healthy life-year gained at 5 years, with costs estimated from the National Health Data System (NHDS), overall survival (defined as the time between the 1st day of treatment and death from any cause), and utility estimated from clinical trial data
次要结局
- Biochemical recurrence-free survival(Up to Year 5)
- Toxicity (GenitoUrea, GenitoIntestial, sexual) of the experimental arm(Up to Year 5)
- Metastatic recurrence-free survival(Up to Year 5)
- Overall survival(Up to Year 5)
- Quality of life(Up to Year 5)