HDR Brachytherapy Used as Monotherapy for Low and Intermediate Risk Prostate Cancer: a Phase II Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- Acute (early) genitourinary and gastrointestinal toxicity
研究概览
简要总结
The purpose of this study is to evaluate High-dose rate (HDR) brachytherapy (1 vs 2 fractions on single implant) as monotherapy for the treatment of low risk and intermediate risk prostate cancer
详细描述
INTRODUCTION:
Several modalities of radiotherapy treatments are available for low and intermediate risk of prostate cancer, all avec similar results on biochemical control and toxicities. Among them, the brachytherapy consist in the implantation of radioactive sources directly in the prostate. Due to the fast dose shot/application of brachytherapy, the irradiation dose is less damaging to neighbor organs. This specific brachytherapy behavior can enhance the control over cancer while reducing toxicities.
Brachytherapy treatment can be delivered by high-dose-rate (HDR) while, at this time, catheters are implanted in the prostate and retrieved right after treatment (10-15 minutes). HDR brachytherapy dose is more coherent than LDR brachytherapy, because it is not under the risk of loss or migration of its source, neither the variations of prostate size due to swelling or shrinkage after the implantation. A more precise and reproducible dose coverage is accomplished with better preserving of the urethra, bladder, and rectum.
Several authors are investigating HDR brachytherapy and comparing doses and the number of fractions of the different treatment plans.
Morton et al. researched the use of one single fraction of 15 Gray HDR with External Beam Radiation Therapy (EBRT) for the treatment of intermediate risk. The investigators found a progression free survival rate higher than 95% at 5 years follow-up, making this the more used treatment plan at this time.
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 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically proven prostate adenocarcinoma
- •Clinical Stage T1c - T2c
- •Gleason Score between 6 and 7
- •PSA < 15 ng / ml
- •Prostate volume < 70 cc as determined by ultrasound or IRM
- •Signed informer consent
- •Clinical conditions for complete diagnosis checkup and treatment procedure
- •Should be able to complete IIEFS,IPSS and QLQ-C30 questionnaires
- •Bone and pelvic scan negative for metastasis
排除标准
- •Prior pelvis radiation
- •Prior Transurethral resection of the prostate (TURP) (less than 6 months)
- •International Prostate Symptom Score: IPSS > 16
- •Contraindication to radiotherapy
- •No prior use of Androgen deprivation therapy (ADT)
- •Observation: 5 alpha-reductase (5AR) inhibitors is authorized.
结局指标
主要结局
Acute (early) genitourinary and gastrointestinal toxicity
时间窗: 10 years
Acute genitourinary and gastrointestinal toxicities of HDR Brachytherapy will be graded using the Radiation Therapy Oncology Group (RTOG) Score at each follow up time point.
次要结局
- Overall survival(10 years)
- Local - Progression free survival (PFS)(10 years)
- Late genitourinary and gastrointestinal toxicities changes(10 years)
- Biochemical failure(10 years)
- Distant - Progression free survival (PFS)(10 years)
- Evolution of the International Prostate Symptom Score (IPSS) and time to return to baseline(3 years)
- Erectile dysfunction rates - IIEF5 score(3 years)
- Associations between dosimetric parameters and toxicity(3 years)
- Associations between iUrethra and toxicity(3 years)
- Changes in the quality of life of patients - EORTC QLQ-C30(5 years)
研究者
Marjory Jolicoeur
MD
CR-CSSS Champlain-Charles-Le Moyne