Study of 4-Fraction Split-Course Stereotactic Ablative Radiation Therapy of the Treatment of Patients With Low and Intermediate Risk Adenocarcinoma of the Prostate
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 6
- 主要终点
- Late toxicity greater than or equal to grade 2 as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria
研究概览
简要总结
This clinical trial studies stereotactic body radiation therapy in treating patients with low- and intermediate-risk prostate cancer. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate, in terms of late toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule.
SECONDARY OBJECTIVES:
I. To evaluate, in terms of acute toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule.
II. To determine stereotactic treatment efficacy through biochemical failure (Phoenix criteria).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have low or intermediate risk adenocarcinoma of the prostate as defined by:
- •Low-risk disease - Histopathology score (Gleason sum): =<6, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA: <10
- •Intermediate-risk disease as either:
- •Histopathology score (Gleason sum) =< 6, T-stage (per current American Joint Committee on Cancer [AJCC] staging criteria): T1c-T2a, and prostate-specific antigen (PSA) > 10 but =< 20; or
- •Histopathology score (Gleason sum) 7 with =< 50% of any cores positive, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA < 10
- •Charlson index of comorbidity score =< 4
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular disease
- •Patients with a history of cancer other than skin cancer within 5 years of the initiation of protocol treatment
- •Patients with a history of pelvic irradiation for any reason
- •Life expectancy < 10 years - Prior treatment with an anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist, or a combination of the two
- •Prior radiation therapy, brachytherapy, or cryotherapy
- •Prior surgical procedure involving peri-rectal and peri-prostatic area
研究组 & 干预措施
Arm I (standard stereotactic body radiation therapy (SBRT)
Patients undergo standard daily fractions of SBRT over 7-8.5 weeks
干预措施: stereotactic body radiation therapy (Radiation)
Arm II (four fraction split-course SBRT)
Patients undergo 2 fractions of SBRT in weeks 1 and 4
干预措施: four fraction split-course SBRT (Radiation)
结局指标
主要结局
Late toxicity greater than or equal to grade 2 as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria
时间窗: 2 years
Will be tested using a continuity corrected chi-square test
次要结局
- Biochemical failure as defined by the Phoenix definition(Up to 5 years)
- Protocol completion rate(Up to 5 years)
- Patient-reported outcomes(Up to 5 years)
- Acute toxicity greater than or equal to grade 2 as defined by the CTCAE version 4 criteria(Up to 90 days)