Moderate Versus Ultra Hypofractionation or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 4
- 主要终点
- Urinary symptoms
研究概览
简要总结
We will investigate whether ultrahypofractionation using stereotactic ablative radiotherapy (SABR) or brachytherapy is as well-tolerated as moderately hypofractionated external beam radiotherapy (EBRT) for treating the prostate in patients with oligometastatic prostate cancer. Secondary aims include assessment of progression-free survival (PFS) and overall survival (OS) as well as cost-effectiveness. We hypothesize that ultrahypofractionation will maintain favorable toxicity profiles and quality of life while achieving comparable or better efficacy, thereby providing a convenient and cost-effective alternative to moderately hypofractionated EBRT.
详细描述
Men newly diagnosed with low volume oligometastatic prostate cancer defined as fewer than 5 bone metastases and/or non regional lymph node involvement who agree to treatment of the primary cancer with radiation will be randomized between standard moderately hypofractionated external radiotherapy (5500 centiGray/20 fractions as per Stampede trial) and one of 3 alternatives: stereotactic body radiotherapy (SABR) to deliver 36 Gy/5 fractions, or low dose rate Iodine 125 permanent seed implant or a single high dose rate temporary implant. The trial will take place in 4 regional cancer centers of British Columbia Cancer Agency, with each center choosing their preferred alternative to 5500/20. To achieve 4 equally sized treatment arms, each randomization is weighted 3:1 for 42 patients in each arm and 168 total accrual. The primary endpoint is urinary quality of life as assessed by the International Prostate Symptom Score (IPSS) . As the typical acute symptoms from each of these radiation modalities has a unique time course, assessments are done at 6 different points during the first 2 years. Secondary endpoints are global quality of life as assessed by Expanded Prostate Cancer Index (EPIC) urinary, bowel and sexual scores, progression free survival, overall survival and cost effectiveness.
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
- •Signed study specific informed consent
- •European Cooperative Oncology Group performance status 0 to 2
- •Histologically confirmed adenocarcinoma of the prostate
- •Any Tumor stage, any T, any N, M1
- •No prior therapy for prostate cancer apart from androgen deprivation
- •Planned for long-term androgen deprivation therapy (greater than 9 months in duration)
- •Patient is able and willing to complete the quality of life questionnaires, and other assessments that are a part of this study
- •For brachytherapy arms, patient must be technically suitable for brachytherapy according to investigator, in terms of bladder function and prostate size.
排除标准
- •High metastatic burden defined as 5 or more bone metastases or visceral metastases
- •Contraindications to EBRT such as active inflammatory bowel disease or previous pelvic radiation
- •For Brachytherapy Arms =: Any prior Transurethral resection of prostate
研究组 & 干预措施
standard
External beam radiotherapy to deliver 5500 centiGray (cGy) in 20 fractions to the prostate over 4 weeks
干预措施: Hypofractionated external beam radiotherapy (Radiation)
High dose rate brachytherapy
A single fraction of 19 Gray (Gy) is delivered to the prostate under anesthesia as an out patient.
干预措施: High dose rate brachytherapy (Radiation)
Permanent seed implant brachytherapy
A single permanent implant of radioactive Iodine-125 seeds is performed under anesthesia as an out patient to deliver 125 Gy to the prostate
干预措施: Permanent seed implant (Radiation)
Stereotactic body radiotherapy
36.25 Gy is delivered to the prostate in 5 fractions given either weekly or every second day, using a SABR technique.
干预措施: Stereotactic body radiotherapy (Radiation)
结局指标
主要结局
Urinary symptoms
时间窗: Baseline to 2 years
International Prostate Symptom score (0/35), higher worse
次要结局
- Expanded Prostate Cancer Index (EPIC) urinary domain(Baseline to 2 years)
- Distant metastatic failure(Baseline to 3 years)
- Cause specific survival(Within 3 years of treatment)
- Cost effectiveness(3 years)
- Biochemical failure (time to increase in prostate specific antigen (ng/ml) to 50% > nadir(Baseline to 3 years)
- EPIC bowel domain(Baseline to 2 years)
- EPIC sexual domain(Baseline to 2 years)
- Nodal progression(Baseline to 3 years)
- Overall survival(3 years)
研究者
Juanita Crook
Professor of Radiation Oncology
British Columbia Cancer Agency