Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer: a Phase III Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Symptomatic urinary infections post HDR brachytherapy
研究概览
简要总结
Phase III study that aims to evaluate the necessity of prophylactic antibiotics use after HDR brachytherapy in the treatment of prostate adenocarcinomas.
详细描述
INTRODUCTION:
High dose rate (HDR) brachytherapy boost with external beam is the current recommended treatment for intermediate and high risk prostate cancers (1, 2). HDR brachytherapy uses transperineal implant (at least 15 prostate catheters) to deliver the calculated dose though a robot that contains the radioactive source. Once treatment is completed, the implant is retrieved and a dressing with an antibiotic ointment is placed on the perineum for a few hours.
The procedure is performed under spinal anesthesia, transperineally following a sterile wash. The implantation is guided from the transrectal ultrasound (TRUS). The procedure contains a series of back and forth probe movements that raises the contamination risk of the implantation zone which is considered non-negligible. Brachytherapy patients undergo urinanalysis before the implantation and redo the test at the least urinary symptom.
The suspicion of a contamination risk of the urinary tract during the procedure has therefore led to antibiotic prophylaxis habit. This habit has been based on experts' opinion mainly motivated by the antibiotic prophylaxis use for TRUS guided biopsies of the prostate.
Literature on antibiotic prophylaxis use for prostate brachytherapy is limited, both on the use of intraoperative or post-procedure antibiotic prophylaxis and on the risk of infectious complications following the brachytherapy procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All patients eligible to brachytherapy for the treatment of prostate cancer
- •No history of serious urinary tract infection post prostate biopsy
排除标准
- •Urosepsis post biopsy
- •Contraindication to brachytherapy
研究组 & 干预措施
Ciprofloxacin
Patients in this arm will receive Ciprofloxacin 400mg IV 120mn (prophylactic antibiotic) before their HDR brachytherapy
干预措施: Ciprofloxacin (Drug)
Cefazolin
Patients in this arm will receive Cefazolin 2000mg IV 60mn (prophylactic antibiotic) before their HDR brachytherapy
干预措施: Cefazolin (Drug)
结局指标
主要结局
Symptomatic urinary infections post HDR brachytherapy
时间窗: from treatment up to 6 months, divided into acute (up to 3 months post treatment) and late (between 3 and 6 months post treatment)
The rate of symptomatic urinary infections post HDR brachytherapy.
次要结局
- Urinary toxicities(5 years)
- IPSS score effects(5 years)
- Serious infectious complications(5 years)
- The risk of colitis due to C. difficile infection(12 weeks)
研究者
Marjory Jolicoeur
Principal Investigator, MD, PhD
CR-CSSS Champlain-Charles-Le Moyne