Comparison of High-dose- Versus Low-dose-rate Brachytherapy as Monotherapy in the Treatment of Early, Organ Confined Prostate Cancer.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Acute side effects
研究概览
简要总结
Investigators compare in a randomized clinical trial the results and side effects of high-dose- and low-dose-rate brachytherapy as monotherapy in the treatment of early, organ confined prostate cancer patients.
详细描述
Permanent implant prostate brachytherapy (LDRPBT) is a well established and proved method in the treatment of patients with low or selected intermediate risk, organ confined prostate cancer.
There are number of studies with high-dose rate brachytherapy (HDRPBT) as monotherapy with several fractionation schedule treating the same group of patients. One phase II trial showed its effectiveness given in one fraction of 19 Gy.
In the trial investigators randomly select patients to treat with either LDR prostate brachytherapy (145Gy) or HDR prostate brachytherapy (1x19Gy) as monotherapy.
Patients are stratified into two pretreatment group: 1. low risk, 2. selected intermediate risk group.
Brachytherapy is given in spinal anaesthesia, using transrectal ultrasound based real time treatment planning. Dose constraints are defined for both methods.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) status <=1
- •40-75 years old
- •expected life expectancy>10 years
- •low risk prostate cancer (Prostate specific antigen (PSA)<=10ng/ml, gleason score <7, T status<=2a), less than 50 % positive biopsy cores
- •selected intermediate prostate cancer (PSA)=10-<15ng/ml or gleason score =3+4(but not 4+3), or T2b-c, less than 50 % positive biopsy cores)
- •International prostate symptom score (IPSS) <=15
- •Prostate volume<=50cm3
- •no pubic interference
- •no prior prostate operation, except biopsy
- •no prior radiation to pelvis
- •patient signed the informed consent
排除标准
- •<40 years or >75 years old
- •PSA>15 ng/ml gleason score 4+3 , score 8-10
- •percent core positivity >50 %
- •TUR operation within six months prior to the brachytherapy prostate volume<10 cm3 or >50 cm3 IPSS >15
结局指标
主要结局
Acute side effects
时间窗: 6 months
Acute gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the Common Toxicity Criteria for Adverse Effects (CTCAE 4.0v) scale
Chronic side effects
时间窗: from 6 months to five year
Chronic gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the CTCAE 4.0v scale
次要结局
- Disease specific survival (DSS)(5 years)
- Locoregional tumor free survival(5 years)
- Biochemical relapse free survival (bRFS)(5 years)
- quality of life(5 years)
研究者
Peter Agoston
MD, PhD
National Institute of Oncology, Hungary