Single Fraction High Dose Rate (HDR) Brachytherapy Plus Hypofractionated External Beam Radiotherapy (EBRT) for Low-risk Prostate Cancer: Phase II Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Acute and Late rectal and urinary morbidity
研究概览
简要总结
The hypofractionated external radiation (EBRT) is a technique that radiation dose delivery using higher daily fractions than those used routinely. In this way can cause more damage tumor, especially in tissues that have a slower proliferation rate, as in the case of prostate cancer. Furthermore, achieves a reduction in total treatment time and probably a lesser chance of development of collateral in tissues of high multiplication rate as the lining of the rectum and bladder effects.
With brachytherapy boost for high dose rate is achieved by administering a more intense dose on the tumor and lower the sound around the region to be treated tissues, improving the therapeutic window.
Treatment with retracted and fully ambulatory time, has potential benefit as early patient return to usual activities and optimizing the flow of patients who require treatment with radiotherapy. This prospective study aims to assess the results and the toxicity profile of this treatment regimen retracted.
详细描述
OBJECTIVE The primary objective is to analyze the toxicity profile, via a phase II study of treatment of patients with low risk prostate cancer with the association of hypo fractionated EBRT and HDR brachytherapy boost.
It will also analyze the biochemical control and expense to the procedure.
STUDY DESIGN Prospective phase II study and not randomized. Patients with localized low-risk prostate cancer will be recruited to participate in protocol hypofractionated external beam radiotherapy followed by brachytherapy high dose rate.
INCLUSION CRITERIA
- Biopsy confirming adenocarcinoma of the prostate;
- Low risk prostate cancer: less than or equal T2a, and less than or equal to 10 ng PSA / ml stage and Gleason score less than or equal to 6
- Prostate volume less than or equal to 60cc.
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 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy confirming adenocarcinoma of the prostate
- •Low-risk Prostate Cancer: less than or equal T2a stage + PSA less than or equal to 10 ng/ml stage + Gleason score less than or equal to 6
- •Prostate volume than or equal to 60cc
排除标准
- •Adjuvant Hormone
- •Prior pelvic radiotherapy
- •Adjuvant Chemotherapy
结局指标
主要结局
Acute and Late rectal and urinary morbidity
时间窗: 12 weeks
toxicity associated with the rectum and urinary tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)
次要结局
- costs analysis of the treatment(one week after the treatment)
- biochemical control(3 years)