Stereotactic Prostate Adaptive Radiotherapy Utilising Kilovoltage Intrafraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 10
- 主要终点
- Accumulated patient dose distributions will be determined via paired controls by comparing the measured treatment accuracy and dose with KIM and those that would have been delivered in the absence of KIM
研究概览
简要总结
The SPARK trial is testing the use of Kilovoltage Intrafraction Monitoring in prostate cancer patients being treated with Stereotactic Prostate Adaptive Radiotherapy. The researchers expect this trial to result in better targeted prostate cancer patient outcomes with lower toxicity. The potential application of Kilovoltage Intrafraction Monitoring to other tumour sites will pave the way for additional trials with Australasian radiation oncology leading the world.
详细描述
Most linear accelerators used to treat cancer patients today are equipped with fixed X-ray imagers which are typically used to take images of a tumour before a patient receives radiotherapy. A new technology, known as Kilovoltage Intrafraction Monitoring has recently emerged which allows images of a tumour to be taken in real-time while the treatment is occurring. The advantage of Kilovoltage Intrafraction Monitoring is that it enables strategies such as patient shifting or beam shifting during treatment which could potentially improve the accuracy of the treatment and reduce the patient's side effects. In addition, due to the accuracy of Kilovoltage Intrafraction Monitoring in targeting tumours, the number of treatment sessions this group of patients will require will be reduced to five as opposed to the 40 sessions required using more conventional treatment methods.
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 proven prostate adenocarcinoma
- •Low or intermediate risk disease as defined by:
- •Low Risk: All of PSA<10 ng/mL, Gleason Grade 6 AND Stage T1 or T2a
- •Intermediate Risk: Any or all of PSA 10-20 ng/mL, Gleason Grade 7 OR Stage T2b-c
- •Absence of high risk features (PSA>20, T3-4, N1 or M1 disease, Gleason score 8-10) (PSA must be within 3 months prior to enrolment)
- •ECOG Performance status 0-2
- •Suitable for definitive external beam radiotherapy (IMRT or VMAT)
- •Ability to have three gold fiducial markers placed in the prostate
- •Six month course of androgen deprivation therapy allowed at clinician discretion.
- •Available for follow up for a minimum of 2 years (up to 3 years)
排除标准
- •Lymph node irradiation
- •Any other systemic anti-prostate cancer therapy (i.e. non-ADT) both proven in the metastatic setting and investigational (e.g. docetaxel, enzalutamide)
- •Artificial hip(s) (Unable to visualise markers through prosthesis)
- •Prostate volume > 90 cm3 measured from the CT scan
- •Patient lateral dimension >40cm as measured at the level of the prostate from the CT scan
- •Suboptimal fiducial markers placement for treatment utilising KIM as assessed by a medical physicist by measuring marker positions from the CT scan
- •Fiducial migration or fewer than 3 fiducials present in the CT scan
研究组 & 干预措施
Multi-fraction SABR
All participants will receive Multi-Fraction SABR; 36.25 Gy (PTV D95) in 5 Fractions within 2-5 weeks
干预措施: Multi-fraction SABR (Radiation)
结局指标
主要结局
Accumulated patient dose distributions will be determined via paired controls by comparing the measured treatment accuracy and dose with KIM and those that would have been delivered in the absence of KIM
时间窗: up to 36 months
次要结局
- Patient treatment outcomes determined by assessing Biochemical-clinical failure (BCF)(up to a maximum of 36 months.)
- The patient's perception of KIM will be quantified using an adapted SAT-RAR survey, an instrument that has previously been used to assess patient perceptions on technological innovations in radiotherapy and respiratory gating.(up to 36 months)
- Targeting accuracy through measuring the final geometric accuracy with and without the KIM gating procedure(up to 36 months)
- Patient treatment outcomes determined by assessing acute and late toxicity grade 3 or higher (using CTCAE version 4)(Weekly during treatment, then two weeks, six weeks and 6 months post treatment)
- Patient treatment outcomes determined by assessing patient-reported outcomes(12 and 24 months after treatment)
- Radiation therapists feedback on KIM will be quantified using a survey which will obtain specific information about the impact of the KIM system and SPARK on education, patient workflow, clinical impact and user confidence(up to 36 months)