Function-Preserving Stereotactic Body Radiotherapy for Clinical State I-III Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Quality of life outcomes (low- and intermediate-risk prostate cancer groups)
研究概览
简要总结
The purpose of this study is to find out the effects (good and bad) of highly focused radiation on you and your prostate cancer. The purpose of this evaluation is to see if this treatment causes fewer side effects that other standard treatment approaches, and to evaluate the effect of this treatment on your prostate tumor and your quality of life over time.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven prostate adenocarcinoma
- •Clinical stage T1a-T3, N0-Nx, M0-Mx
- •Patients belonging in one of the following risk groups: (1) LOW RISK: CS T1a-T2a, Gleason 2-6, PSA<10, Nx-0, Mx-0; (2) INTERMEDIATE RISK: CS T2b, Gleason ≤7, PSA<20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 2-6, PSA≥10 & <20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 7, PSA≤20, Nx-0, Mx-0; or (3) HIGH RISK: CS T2c-T3, any Gleason, any PSA, or CS T1-3, Gleason ≥8 and/or PSA≥20
- •Karnofsky performance status 70-100
- •Hormone therapy: includes LHRH agonists (e.g. leuprolide, goserelin, triptorelin), antagonists (e.g. degarelix), peripheral blockers (e.g. flutamide, bicalutamide, nilutamide), estrogens (e.g. DES) and bilateral orchiectomy
- •Low and Intermediate risk groups: no hormone ablation for two months prior to enrollment, or during treatment
- •High risk group: three hormone therapy regimens are allowed
- •5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are allowed
排除标准
- •Prior prostatectomy or cryotherapy of the prostate
- •Prior high-dose radiotherapy to the prostate or lower pelvis
- •Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
研究组 & 干预措施
CyberKnife Stereotactic Radiosurgery
This treatment concentrates large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. CyberKnife Stereotactic Radiosurgery is not investigational and is considered standard of care.
干预措施: CyberKnife Stereotactic Radiosurgery (Radiation)
结局指标
主要结局
Quality of life outcomes (low- and intermediate-risk prostate cancer groups)
时间窗: 8 years
In the low- and intermediate-risk prostate cancer groups, to determine whether study treatment improves patient-reported quality of life outcomes compared to the approach used in a previous multi-center cyberknife stereotactic radiosurgery trial.
Rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities (high-risk group)
时间窗: 8 years
In the high-risk group, to estimate rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities following cyberknife stereotactic radiosurgery.
次要结局
- Overall survival(5 years)
- Disease free survival(5 years)
- Rates of toxicities related to treatment(5 years)