Magnetic Resonance Imaging-Guided Stereotactic Body Radiotherapy for Prostate Cancer (Mirage): A Phase III Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 179
- 试验地点
- 2
- 主要终点
- Incidence of acute grade >= 2 genitourinary (GU) physician-reported toxicity
研究概览
简要总结
This phase III trial studies compares CT-guided stereotactic body radiation therapy and MRI-guided stereotactic body radiation therapy (SBRT) in treating prostate cancer. Image-guided SBRT is a standard treatment for prostate cancer, which combines imaging of the cancer within the body with the delivery of therapeutic radiation doses produced on a linear accelerator machine. Imaging modalities for image-guided SBRT can be either computed tomography imaging (CT), magnetic resonance imaging (MRI), or a combination of the two. This research is being done to help determine whether there are benefits to MRI-guidance over CT-guidance in patients who are receiving the same radiation dose by SBRT to treat prostate cancer.
详细描述
PRIMARY OBJECTIVE:
I. To determine whether (MRI)-guided stereotactic body radiotherapy (SBRT) improves acute physician-scored genitourinary (GU) toxicity when compared with standard computed tomography (CT)-guided SBRT for prostate cancer (PCa).
SECONDARY OBJECTIVES:
I. To determine whether there are differences in acute grade >= 2 gastrointestinal (GI) toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale, following MRI-guided SBRT versus CT-guided SBRT.
II. To determine whether there are differences in 5-year cumulative incidences of late grade >= 2 GU and GI physician-reported toxicity, following MRI-guided SBRT versus CT-guided SBRT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 confirmed, clinical localized adenocarcinoma of the prostate
- •No evidence of disease beyond the prostate and/or seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis)
- •Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping:
- •Low risk: No staging workup required
- •Favorable intermediate-risk: CT abdomen/pelvis if Memorial Sloan Kettering Cancer Center (MSKCC) nomogram predicts >10% probability of lymph node involvement
- •Unfavorable intermediate-risk: technetium bone scan, CT abdomen/pelvis if MSKCC nomogram predicts >10% probability of lymph node involvement
- •High-risk: technetium bone scan, CT abdomen/pelvis if MSKCC nomogram predicts >10% probability of lymph node involvement
- •Advanced imaging studies (i.e. prostate-specific membrane antigen positron emission tomography [PSMA PET] and axumin scan) can supplant a bone scan if performed first
- •Ability to understand, and willingness to sign, the written informed consent
排除标准
- •Patients with neuroendocrine or small cell carcinoma of the prostate
- •Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator
- •Prior cryosurgery, high intensity focused ultrasound (HIFU) or brachytherapy of the prostate
- •Prior pelvic radiotherapy
- •History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
- •Contraindications to MRI, including:
- •Electronic devices such as pacemakers, defibrillators, deep brain stimulators, cochlear implants;
- •Metallic foreign body in the eye or aneurysm clips in the brain;
- •Severe claustrophobia
结局指标
主要结局
Incidence of acute grade >= 2 genitourinary (GU) physician-reported toxicity
时间窗: 90 days after stereotactic body radiation therapy (SBRT)
Will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale.
次要结局
- Incidence of acute grade >= 2 gastrointestinal (GI) toxicity(90 days after SBRT)
- Biochemical recurrence-free survival (BCRFS)(5 years)
- Incidences of late grade >= 2 GU toxicity(Up to 5 years)
- incidences of late grade >= 2 GI toxicity(Up to 5 years)
- Patient-reported quality of life (QOL) outcomes(Up 5 years)