A Randomized Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Health related quality of life (QoL)
研究概览
简要总结
A single high dose rate brachytherapy (HDR) treatment combined with a short course of external beam radiotherapy (EBRT) is a highly effective and well tolerated treatment for men with intermediate risk prostate cancer. High cancer control rates have also been reported with HDR used on its own, without the EBRT. The challenge has been to determine what HDR dose to use with a move towards one or two fractions by several investigators. These schedules are reported to be well tolerated in the short term, but with little long term data. The objective of this study is to investigate HDR monotherapy given as either one fraction of 19 Gy or two fractions of 13.5 Gy in a randomized phase II clinical trial. The primary endpoint is patient reported toxicity and health related quality of life at 1 year, and efficacy data will be also be analyzed. Sample size for the study is 174 patients, which we expect to accrue within 18 months.
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
- •histologically confirmed diagnosis of adenocarcinoma of the prostate
- •low and intermediate risk disease defined as either Gleason 6 or Gleason 7 and PSA < 20ng/mL. PSA to be drawn within 60 days of registration
- •prostate volume < 60 cc as determined by ultrasound, CT or MRI
- •willing to give informed consent ot participate in this clinical trial
- •able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire
排除标准
- •documented nodal or distant metastases
- •previous pelvic radiotherapy
- •previous trans-urethral resection of prostate, previous prostatectomy or Highly Focused Ultrasound (HIFU)
- •use of androgen deprivation therapy. Use of 5-alpha reductase inhibitors is permitted
- •poor baseline urinary function defined as radiotherapy eg. connective tissue disease or inflammatory bowel disease
- •significant medical co-morbidity rendering patient unsuitable for general anaesthetic
研究组 & 干预措施
HDR 2 fractions
HDR brachytherapy of 27 Gy delivered in 2 fractions one week apart
干预措施: HDR 2 Fraction (Radiation)
HDR 1 fraction
HDR brachytherapy of 19 Gy delivered in a single fraction
干预措施: HDR 1 Fraction (Radiation)
结局指标
主要结局
Health related quality of life (QoL)
时间窗: 1 year
To demonstrate that health related QoL at 1 year in the urinary and bowel domains of the Expanded Prostate Index Composite (EPIC) for at least one HDR monotherapy arm is not worse than that following current standard treatment with single fraction HDR combined with supplemental external beam radiotherapy.
次要结局
- Biochemical failure and disease free survival rates(5 years)
- Urinary Symptoms(baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly for the first 3 years, annually until 5 years)
- GU and GI toxicities(baseline, 6 weeks post treament, 3mths, 6mths, 6 monthly for the first 3 years, annually up to 5 years)
- Erectile function(5 year)
- Serum PSA changes(baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly up to 3 years, annually until 5 years)
- Associations between dosimetric parameters and toxicity/EPIC domains(5 years)
研究者
Dr. Gerard Morton
Dr. Gerard Morton
Sunnybrook Health Sciences Centre