NCT00619515终止不适用
Prospective Evaluation of Cyberknife Stereotactic Radiosurgery for Low and Low/Intermediate Risk Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 73
- 试验地点
- 4
- 主要终点
- Number of Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0
研究概览
简要总结
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This trial is studying the side effects of stereotactic radiation therapy and to see how well it works in treating patients with prostate cancer.
详细描述
OBJECTIVES:
Primary
- To estimate in both low- and low-to-intermediate-risk groups of patients with prostate cancer, the rate of acute toxicities observed during the 5 years following CyberKnife® stereotactic radiosurgery (SRS).
Secondary
- To estimate the rate of late grade 3-5 toxicities after SRS in these patients.
- To measure biochemical disease-free survival of patients treated with this therapy.
- To measure rates of local failure, distant failure, disease-free survival, disease-specific survival, and overall survival of patients treated with this therapy.
- To measure quality of life in generic and organ-specific domains in patients treated with this therapy.
- To evaluate imaging modalities and their potential role in the detection of prostate cancer persistence, recurrence, and/or progression in patients treated with this therapy.
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
- — 至 120 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •Disease confirmed by biopsy within 1 year of study entry
- •Gleason score 2-7(3+4)
- •Clinical stage T1a or T2b, N0 or NX, M0 or MX
- •T- stage and N-stage determined by physical exam and available imaging studies (i.e., ultrasound, CT scan, and/or MRI)
- •M-stage determined by physical exam, CT scan, and/or MRI
- •Bone scan is not required unless clinical findings suggest possible osseous metastases
- •PSA ≤ 10 ng/mL within the past 60 days
- •At risk for recurrence, as defined by 1 of the following risk groups:
- •Low-risk, defined by the following combination:
- •Stage T1a-T2a, Gleason 2-6, and PSA ≤ 10 ng/mL
- •Low- to-Intermediate-risk, defined by either of the following combinations:
- •Stage T2b, Gleason 2-6, and PSA ≤ 10 ng/mL
- •Stage T2b, Gleason 3+4=7, and PSA ≤ 10 ng/mL
- •Prostate volume must be ≤ 100 cc
- •Determined by measurement from CT scan or ultrasound within the past 90 days or within the past 14 days if hormone therapy is given
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
- •PRIOR CONCURRENT THERAPY:
- •No prior definitive therapy for prostate cancer, including prostatectomy, cryotherapy, or radiotherapy to the prostate or lower pelvis
- •No more than 6 months of hormone ablation for gland downsizing
排除标准
- 未提供
研究组 & 干预措施
CyberKnife® stereotactic radiosurgery
Experimental
干预措施: questionnaire administration (Other)
CyberKnife® stereotactic radiosurgery
Experimental
干预措施: implanted fiducial-based imaging (Procedure)
CyberKnife® stereotactic radiosurgery
Experimental
干预措施: stereotactic radiosurgery (Radiation)
结局指标
主要结局
Number of Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0
时间窗: Within 90 days of completing treatment
This study's primary goal is to determine the rate of acute grade 3-5 toxicities following CyberKnife treatment. Per RTOG/ECOG, acute toxicity will be defined as occurring within 90 days of completing treatment.
次要结局
- Disease-specific Survival(Assessed yearly for 5 years)
- Overall Survival(Assessed yearly for 5 years)
- Number of Late Grade 3-5 Toxicities as Assessed by NCI CTCAE v3.0(Within 5 years of completing treatment)
- Biochemical Disease-free Survival(Assessed at months 3,6,12,18,24 and every 6 months through 5 years)
- Disease-free Survival (Phoenix and ASTRO Definitions)(Assessed yearly for 5 years)
- Rate of Local Failure(Assessed at months 3,6,12,18,24 and every 12 months through 5 years)
- Quality of Life as Measured by the Short Form-12 Health Survey, Expanded Prostate Cancer Index Composite, and the American Urological Association Symptom Index, and the Utilization of Sexual Medications/Devices(Survey at 1,6,12 months and yearly up to 5 years)
- Rate of Distant Failure(Assessed at months 3,6,12,18,24 and every 12 months through 5 years)
研究者
研究点 (4)
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