Phase II Study of Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate for Treatment of Localized, Non-Metastatic, High Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Document rate of biochemical Disease-Free Survival (bDFS)
研究概览
简要总结
In this study, participants will have standard Androgen Deprivation Therapy and undergo standard external beam radiation therapy to the prostate and at-risk lymph nodes by Intensity Modulated Radiation Therapy. The subsequent *boost* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.
详细描述
In this study, participants will have standard androgen deprivation therapy and undergo standard radiation therapy to the prostate and at-risk lymph nodes by intensity-modulated radiation therapy (IMRT). The subsequent *boost* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically proven adenocarcinoma of the prostate
- •Gleason score (2-10)
- •Biopsy within six months of date of registration
- •Patient age >18 years
- •Clinical stage (American Joint Committee on Cancer 7th Edition)
- •a. T-stage determined by physical exam (Digital Rectal Exam Required)
- •i. MRI findings (e.g. extracapsular extension) can be used to determine T-staging
- •b. N-stage determined using abdominopelvic CT scan and/or MRI
- •c. M-stage determined by physical exam, CT and/or MRI, and bone scan (must be M0, excepting Lymph nodes)
- •Please note: a SPECT bone scan including a CT of the abdomen and pelvis or an F18 Fluciclovine PET/CT fulfills protocol criteria for both the abdominopelvic CT and bone scan.
- •Patients must belong to one of the following risk groups:
- •PSA > 20 and < 150 and/or
- •Gleason 8-10 and/or
- •> clinical T3a and/or
- •Clinical N1
- •PSA 10 - 20 AND
- •Gleason 7 AND
- •Clinical T2b - T2c
- •Patient is receiving, or planning to receive standard androgen deprivation therapy and initial IMRT to the prostate and positive or at-risk lymph nodes.
- •Prostate volume greater than 20 cc and less than 100 cc
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Patient has agreed to complete questionnaires
- •Signed IRB approved informed consent
- •Patient eligible to have an MRI
- •Must be able to tolerate the confinement of an MRI procedure
排除标准
- •No prior prostate surgery (including TURP) or prostate cancer treatment with the exception of androgen deprivation therapy
- •No prior radiotherapy to the pelvis
- •No implanted hardware (including metal) or other material that would prohibit appropriate treatment planning or treatment delivery
- •No metastatic disease, with the exception of lymph node positive disease
- •No chemotherapy for a malignancy in the last 5 years.
- •No history of an invasive malignancy (other than basal or squamous skin cancers) in the last 5 years.
- •No heart pacemaker, No metallic foreign body (metal sliver) in the eye, No aneurysm clip in the brain
- •No history of a pelvic or horseshoe kidney
- •No diagnosis of inflammatory bowel disease
研究组 & 干预措施
Boost
CyberKnife Boost 21 Gy in 7 Gy per day, 3 fractions, Every other day
干预措施: CyberKnife Boost (Radiation)
结局指标
主要结局
Document rate of biochemical Disease-Free Survival (bDFS)
时间窗: 5 years
To document the rate of biochemical Disease-Free Survival (bDFS), American Society for Radiation Oncology definitions
次要结局
- Rate of local failure(5 years)
- Rate of distant failure(5 years)
- disease-free survival(5 years)
- Rate of disease-specific survival(5 years)
- Rate of overall survival(5 years)
- Estimate the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity(5 years)