Medical and Economic Evaluation of an External Beam Radiotherapy Combined With a Brachytherapy Boost Compared With an Exclusive External Beam Radiotherapy for Intermediate-risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 298
- 试验地点
- 29
- 主要终点
- Comparison of the biochemical relapse free survival of the patients in two groups at 5 years for an external beam radiotherapy with a brachytherapy boost versus an exclusive external beam radiotherapy
研究概览
简要总结
The aim of the present phase III study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment.
The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 80 years;
- •life expectancy of greater than 10 years;
- •prostate adenocarcinoma histologically proven;
- •prostate cancer has to be of intermediate-risk based on at least one of the three following criteria: PSA between 10 ng/ml and 20 ng/ml, and/or a Gleason score of 7 and/or a T2B. Karnofsky performance status ≥ 60% and consequently performance status ECOG 0-
- •the patient has to be the beneficiary of the social security system (order n° 2006-477 from April 26th 2006);
- •the signed consent form.
排除标准
- •PSA level > 20;
- •Gleason > 7;
- •clinical T3A or T3B or MRI (a simple suspicion/ doubt on the MRI regarding the T3A won't be an exclusion criterion);
- •prostate volume > 60 cc;
- •pelvic lymph nodes involvement at dissection or imaging (ADP > 1.5 cm);
- •concurrent hormone therapy;
- •the presence of distant metastasis (M1);
- •history of abdominal or pelvic irradiation;
- •history of prostate resection in the previous 6 months and/or not allowing the implantation of markers;
- •history of uncontrolled cancer and/or treated since less than 5 years (excepting the basal-cell carcinoma);
- •urinary discomfort with an IPSS (International Prostate Symptom Score) > 15 (without alpha-blocking);
- •inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease;
- •other undergoing study that may interfere with the present study;
- •patient under legal protection measure.
研究组 & 干预措施
Brachytherapy boost
Brachytherapy boost with external beam radiotherapy. External beam radiotherapy of 46 Gy delivered to the prostate and the first centimeter of the seminal vesicles with a brachytherapy boost (of iodine-125 seeds (110Gy) or high dose rate (14Gy) with iridium-192) only to the prostate. Each center will choose the appropriate brachytherapy technique
干预措施: Brachytherapy boost with external beam radiotherapy (Radiation)
Exclusive external beam irradiation
Exclusive external beam radiotherapy. External beam radiotherapy of 46 Gy delivered to the prostate and the first centimeter of the seminal vesicles with an external beam radiotherapy of 80 Gy to the prostate alone.
干预措施: Exclusive external beam radiotherapy (Radiation)
结局指标
主要结局
Comparison of the biochemical relapse free survival of the patients in two groups at 5 years for an external beam radiotherapy with a brachytherapy boost versus an exclusive external beam radiotherapy
时间窗: 5 years
Biochemical relapse is defined using the Phoenix definition of nadir of Prostate Specific Antigen + 2 ng/ml. This will be studied for both arms
次要结局
- The evaluation of the overall survival at 5 years.(5 years)
- The evaluation of the specific survival at 5 years(5 years)
- The evaluation of the survival without any metastatic evolution at 5 years(5 years)
- The study of all toxicities(5 years)
- Medical and economical evaluation.(5 years)