A Randomised Feasibility Study Evaluating Stereotactic Prostate Radiotherapy In High-Risk Localised Prostate Cancer With or Without Elective Nodal Irradiation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Adequate recruitment rate
研究概览
简要总结
The study will examine stereotactic ablative body radiotherapy (SABR), a new technique to deliver radiotherapy to men with prostate cancer. In addition to this, it will look at the effect of SABR on levels of markers of radiation exposure and bowel damage, along with other potential markers of outcome and side effects. Quality of life and any side effects that develop during and after treatment will also be assessed.
详细描述
The study will examine stereotactic ablative body radiotherapy (SABR), a new technique to deliver radiotherapy to men with prostate cancer. In addition to this, it will look at the effect of SABR on levels of markers of radiation exposure and bowel damage, along with other potential markers of outcome and side effects. Quality of life and any side effects that develop during and after treatment will also be assessed.
Participants will be treated with five treatments (instead of the standard 37). This is more convenient for them and also allows the treatment of many more people in the same time frame, which should improve the timely delivery of radiotherapy for all patients.
Thirty men with high-risk prostate cancer will be enrolled into the study. They will all be treated with hormone therapy and radiotherapy to the prostate and seminal vesicles. In addition, half of the men will receive an additional dose of radiation to their pelvis. Gold markers will be placed in the prostate before radiotherapy to allow precise targeting of the prostate during treatment. CT scans are taken before and after each treatment to ensure the accuracy of its delivery.
Blood urine and prostate tissue samples will be taken before, during and after radiotherapy. Side effects and quality of life will also by assessed during this time.
Ultimately, this may allow us to predict which men are at increased risk of side effects from radiotherapy and allow closer monitoring, earlier intervention and perhaps alternative treatments in some cases. This should improve the control of prostate cancer and reduce the risk of serious treatment-related side effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Not applicable - no masking
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
- •Patients with histologically confirmed prostate adenocarcinoma who elect for radical radiotherapy, with at least one of the following features:
- •clinical stage T3a N0 M0
- •Gleason score 7 (4+3) or above
- •PSA > 20
- •No evidence of nodal or distant metastatic disease
- •WHO performance status 0-2
- •Life expectancy of at least 5 years
- •Men greater than or equal to 18 years
- •Ability to understand and willingness to sign a written informed consent document (completed prior to registration and subsequent randomization), along with willingness to co-operate with follow-up
- •Planned to receive 12-36 months of ADT as part of standard treatment
排除标准
- •T stage greater than or equal to T3b / T4
- •Prostate volume > 90cc
- •Current evidence of:
- •inflammatory bowel disease or other chronic bowel disorder
- •Autoimmune disease
- •Active uncontrolled bacterial, viral or fungal infection
- •Serious uncontrolled concomitant disease
- •Known coagulopathy or bleeding diasthesis
- •Anticoagulation medication (if unsafe to insert for seed insertion)
- •Bilateral hip prosthesis or fixation which would interfere with standard radiation beam configuration
- •Concurrent experimental or cytotoxic drugs
- •Allergy to gold
- •Severe lower urinary tract symptoms - International Prostate Symptom Score (IPSS) > 19
- •Any other contra-indication to hormonal therapy or radical radiotherapy.
- •History of:
- •Previous major abdominal surgery or history of bowel adhesions
- •Prior pelvic radiotherapy
- •Active malignancy within the preceding five years (other than basal cell carcinoma)
- •Evidence of:
- •Castrate-resistance (rising PSA with castrate levels of testosterone on LHRHa and anti-androgen)
研究组 & 干预措施
SABR to prostate / seminal vesicles with pelvic ENI
36.25Gy / 5 fractions to prostate and seminal vesicles with additional SABR (25Gy /5 fractions) delivered to the pelvic nodes.
干预措施: Stereotatic Radiotherapy (Radiation)
SABR to prostate and seminal vesicles only
36.25Gy / 5 fractions to prostate and seminal vesicles.
干预措施: Stereotatic Radiotherapy (Radiation)
结局指标
主要结局
Adequate recruitment rate
时间窗: 24 months
adequate recruitment rate (30 patients in 24 months)
Acute toxicity of SABR
时间窗: 90 days of completion of SABR
Acute toxicity of SABR (as assessed by CTCAE v4.03 scores until 90 days of completion of SABR)
Quantification of acute toxicity in each treatment group
时间窗: until 90 days post completion of radiotherapy
Quantification of acute toxicity in each treatment group to enable calculation of the sample size for the Phase II RCT (using CTCAE v4.03 scores measured until 90days post completion of radiotherapy)
Number of SABR plans delivered as planned and on schedule
时间窗: 29 days (treatment period)
Number of SABR plans delivered as planned and on schedule
Acute quality of life during and after SABR
时间窗: 90 days after completion of SABR
Acute quality of life during and after SABR (as assessed by EPIC and IPSS scores until 90 days after completion of SABR)
次要结局
- Overall survival(up to ten years post completion of SABR)
- Late toxicity of SABR(from 90 days and up to ten years post completion of SABR)
- Late patient-reported quality of life(up to ten years post completion of SABR)
- Prostate cancer-specific survival(up to ten years post completion of SABR)
- Rate of PSA failure(up to ten years post completion of SABR)