A Phase III Randomized Study of Low Dose Rate Compared to High Dose Rate Prostate Brachytherapy for Favorable Risk and Low Tier Intermediate Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 1
- 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
H17-02904 is a randomized comparison of low dose rate vs. high dose rate prostate brachytherapy for favorable and intermediate risk prostate cancer suitable for brachytherapy as monotherapy. This is a continuation with expanded accrual of the randomized Pilot study H15-02103
详细描述
Men suitable for prostate brachytherapy as monotherapy will undergo multiparametric Magnetic Resonance Imaging for staging and identification of a dominant lesion and will be randomly selected for either a single low dose rate permanent seed implant or 2 fractions of high dose rate brachytherapy. Using image registration techniques, dominant lesions will be biopsied under anesthesia at the start of the brachytherapy procedure. Biopsies will reviewed for tumor Gleason score and sent for Cell Cycle Progression testing (Prolaris). Patients receiving high dose rate brachytherapy will also have biopsies between the 2 fractions to assess tumor changes induced from the first fraction. Post implant quality assurance will determine the dose to the dominant lesions and compare these between the 2 types of brachytherapy. Post implant symptoms will be tracked for severity and time course.
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
- •Favorable risk and low-tier intermediate-risk prostate cancer with estimated life expectancy of at least 10 years.
- •Clinical stage T1c-T2b, PSA < 20, Gleason < 8
- •Low tier intermediate-risk prostate cancer is defined by a single NCCN intermediate risk factor
- •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
- •PSA > 10 and Gleason 3+4
- •PSA 10-15 ng/ml and Gleason 4+3
- •-< 33% of cores involved
- •-Max tumor 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 anesthesia 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 anesthesia, 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: 0-60 months
The urinary domain of the EPIC prostate cancer specific QOL questionnaire will be assessed.
次要结局
- Histologic Outcome(3 years)
- Acute and long term toxicity([Time Frame: 0-10 years])
- Tumor oxygenation and cell cycle distribution(1 month to 10 years.)
- Biochemical Outcome(5-10 years)
- Cell cycle progression score(1 month to 10 years)
- Quality of Life in the bowel and sexual domains(0-60 months)
- Time to return to baseline +/- 3 points for the International Prostate Symptom Score(0-60 months)