Study of Stereotactic Body Radiotherapy (SBRT) for High-Risk Localized Prostrate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Biochemical progression free survival
研究概览
简要总结
This clinical trial studies stereotactic body radiation therapy in treating patients with high-risk prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Stereotactic body radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Studying quality of life in patients undergoing stereotactic body radiation therapy may help identify the long-term effects of treatment on patients with prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. To establish the efficacy of stereotactic body radiation therapy (SBRT) in patients with high-risk localized prostate cancer compared to historical data from clinical trials.
II. To establish the safety with physician-reported outcomes after SBRT in patients with high risk localized prostate cancer.
III. To establish the quality of life with patient-reported validated questionnaires after SBRT in patients with high risk localized prostate cancer.
OUTLINE:
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 confirmed primary non-metastatic adenocarcinoma of the prostate
- •Risk-group classification into the D’Amico or National Comprehensive Cancer Network (NCCN) ‘high-risk’ group, as defined by the presence of any one of the following high-risk factors:
- •Pre-biopsy prostate-specific antigen (PSA) >= 20
- •Biopsy Gleason score 8-10
- •Clinical stage T3
- •No pelvic nodal metastases (based on computed tomography [CT] or magnetic resonance imaging [MRI] findings)
- •No distant metastases, based upon:
- •CT scan or MRI of the pelvis within 120 days prior to registration
- •Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis
- •Karnofsky performance status (KPS) >= 70
- •Ability to understand, and willingness to sign, the written informed consent
- •Patient will have opted for SBRT among definitive treatment choices
排除标准
- •Patients with any evidence of distant metastases
- •Hormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist or oral anti-androgen) exceeding 4 months prior to registration
- •Prior cryosurgery, high intensity focused ultrasound (HIFU) or brachytherapy of the prostate
- •Prior pelvic radiotherapy
- •History of Crohn’s disease or Ulcerative colitis
研究组 & 干预措施
Treatment (SBRT)
Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician.
干预措施: stereotactic body radiation therapy (Radiation)
Treatment (SBRT)
Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician.
干预措施: quality-of-life assessment (Other)
Treatment (SBRT)
Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician.
干预措施: laboratory biomarker analysis (Other)
Treatment (SBRT)
Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician.
干预措施: androgen deprivation therapy (Drug)
结局指标
主要结局
Biochemical progression free survival
时间窗: At 5 years
Biochemical progression is defined as rising PSA profile of \> 2 ng/mL above post-SBRT nadir.
Incidence of patient-reported genitourinary (GU) and gastrointestinal (GI) toxicity based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4
时间窗: At 4 months
Incidence of patient-reported GU and GI toxicity based on the CTCAE version 4
时间窗: Up to 5 years
Changes in health related quality of life based on Expanded Prostate Cancer Index Composite questionnaire
时间窗: Baseline to up to 5 years
Biochemical progression free survival
时间窗: At 3 years
Biochemical progression is defined as rising PSA profile of \> 2 ng/mL above post-SBRT nadir.
次要结局
未报告次要终点