A Phase III Randomized Pilot Study of Low Dose Rate Compared to High Dose Rate Prostate Brachytherapy for Favourable Risk and Low Tier Intermediate Risk Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy.
研究概览
简要总结
This study will offer men with intermediate risk prostate cancer who are suitable for, and interested in, prostate brachytherapy, the opportunity to be randomized between low dose rate (LDR) brachytherapy using permanent implantation of radioactive seeds (the current standard of care in BC) and high dose rate (HDR) or temporary brachytherapy which is also available as a standard of care in BC but only when used as a boost in addition with external beam radiotherapy. In addition, men will be offered the opportunity for testing the aggressiveness of their cancer using Cell Cycle Progression Gene Profile.
详细描述
Purpose:
To conduct a Phase III randomized trial for favorable tier intermediate risk prostate cancer and selected favorable risk tumors to evaluate the difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy.
Hypothesis:
Because of more rapid dose delivery with HDR compared to LDR brachytherapy (15 minutes vs. 6 months) and more precise control of dose to adjacent critical structures (prostatic and bulbo-membranous urethra and anterior rectal wall), HDR prostate brachytherapy has been associated with more rapid recovery from acute symptoms and a more favorable side effect protocol when used as a boost in combination with external beam radiotherapy. The hypothesis is that this advantage will be maintained when brachytherapy is used as monotherapy without the addition of external beam radiation.
Justification:
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Clinical stage T1c-T2b, PSA < 20, Gleason < 8
- •Low tier intermediate-risk prostate cancer is defined by;
- •o a single NCCN intermediate risk factor (either Gleason 7(3+4) and PSA < 10 ng/ml OR Gleason 6 and PSA 10-20 ng/ml)
- •Extensive favorable-risk disease is defined as:
- •clinical stage T1c-T2a
- •PSA < 10
- •Gleason 6
- •≥ 50% of biopsy cores containing cancer
- •PSA density > 0.2 ng/cc
- •Selected intermediate risk patients not defined above
- •- T1c/T2a
- •- PSA < 10
- •-Gleason 4+3
- •-< 33% of cores involved
- •-Max tumour length in any core 10 mm
- •No androgen deprivation therapy (ADT)
- •Prostate volume by TRUS ≤ 60 cc.
- •Not eligible for, or accepting of, active surveillance according to NCCN guidelines.
- •Signed study specific informed consent.
排除标准
- •Prior radical surgery for carcinoma of the prostate,
- •Prior pelvic radiation
- •Prior chemotherapy for prostate cancer,
- •Prior TURP or cryosurgery of the prostate
- •Claustrophobic or unable to undergo MRI
研究组 & 干预措施
Low dose rate brachytherapy
Device: Radiation Low dose rate prostate brachytherapy is delivered under anaesthesia in a single 1.5-2 hour procedure as an out-patient. The men return 4 weeks later for detailed imaging to assess implant quality.
干预措施: Low dose rate prostate brachytherapy (Radiation)
High dose rate brachytherapy
Device: Radiation High dose rate prostate brachytherapy is delivered in 2 procedures, 2 weeks apart, also under anaesthesia, but no follow-up imaging visit is required.
HDR brachytherapy is also accomplished as an out-patient.
干预措施: High Dose Rate prostate brachytherapy (Radiation)
结局指标
主要结局
The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy.
时间窗: 0-36 months
The urinary domain of the EPIC prostate cancer specific QOL questionnaire will be assessed.
次要结局
- Quality of Life in the bowel and sexual domains(0-36 months)
- Time to return to baseline +/- 3 points for the International Prostate Symptom Score(0-36 months)
- Acute and long term toxicity(0-10 years)
- TRUS- MRI fusion(baseline)
- Histologic Outcome(3 years)
- Biochemical Outcome(5-10 years)
- Cell cycle progression score(one month)
研究者
Juanita Crook
Professor of Radiation Oncology
British Columbia Cancer Agency