IMPROVING QUALITY OF LIFE AFTER OPTIMAL RADIOTHERAPY FOR INTERMEDIATE AND HIGH RISK PROSTATE CANCER: A Randomized Comparison of HDR Versus LDR BRACHYTHERAPY BOOST
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Compare Quality of Life between two arms as measured by EPIC questionnaire
研究概览
简要总结
Optimal non surgical treatment of prostate cancer requires dose escalation which is frequently provided by adding a brachytherapy "boost" to a short course of external beam radiotherapy. The hypothesis in this randomized study is that a High Dose Rate (HDR) brachytherapy boost leads to equivalent or better Prostate Specific Antigen (PSA) recurrence-free survival when compared to a Low Dose Rate (LDR) brachytherapy boost and that it is associated with a more favorable toxicity profile and improved quality of life.
详细描述
Men with intermediate or high risk prostate cancer who are technically suitable for prostate brachytherapy based on prostate size and voiding function and who are interested in this modality of treatment will be approached for randomization between either high dose rate (single 15 Gray) or low dose rate permanent seed implant (110 Gray) brachytherapy. Baseline International Prostate Symptom score, Quality of Life Assessment and International Index of Erectile Function will be recorded and then every 3 months for the first year and every 6 months to 3 years. Androgen deprivation treatment is allowed for 6 or 12 months.
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Upper tier intermediate risk with at least 2 of the following factors
- •Tumor-Nodes-Metastases Tumor stage T2B or greater
- •Gleason Score 7
- •> 50% of the biopsies positive
- •OR High risk prostate cancer with one of the following factors
- •Gleason Score8-10
- •Positive prostate biopsy within 12 months (reviewed centrally)
- •International Prostate Symptom Score < 16
- •Prostate volume < 60 cc
- •Negative staging CT and Bone scan within 3 months prior to registration
- •History and physical examination within 90 days prior to registration
- •European Cooperative Oncology Group performance status 0-1 prior to registration
- •Patient suitable for procedure under anesthesia
排除标准
- •Prior invasive malignancy (except non melanoma skin cancer) unless disease-free for at least 3 years prior to registration
- •Previous prostatectomy, cryotherapy or High Intensity Focussed Ultrasound for prostate cancer
- •Previous pelvic irradiation or prostate brachytherapy
研究组 & 干预措施
LDR boost
After completion of 46 Gy of external beam radiotherapy subjects will undergo a permanent seed radioactive implant to the prostate using iodine-125 seeds to deliver a dose of 110 Gy
干预措施: LDR (Radiation)
HDR boost
Subjects in this arm will undergo an HDR implant to deliver 15 Gy to the prostate prior to commencing the external beam component of their treatment.
干预措施: HDR (Radiation)
结局指标
主要结局
Compare Quality of Life between two arms as measured by EPIC questionnaire
时间窗: 6 months
Quality of life will be measured through validated instruments including International Prostate Symptom Score (IPSS), the International Index of Erectile Function ((IEF), and the urinary, bowel and sexual domains of the Expanded Prostate Cancer Index Composite (EPIC). IPSS has 7 questions related to voiding symptoms, each scored 0-5, with a higher score indicating worse symptoms. IIEF has 5 questions, each scored 0-5 with a higher score indicating better function. EPIC has several questions for each domain with an overall higher score associated with better QoL in that domain.
次要结局
- Quality of Life long term(5 years)