NCT04489745进行中（未招募）2 期
Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer
VA Greater Los Angeles Healthcare System0 个研究点目标入组 72 人开始时间: 2016年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
- 主要终点
- progression free survival
研究概览
简要总结
This is a trial of 5 fraction SBRT combined with androgen deprivation therapy for patients with localized high-risk or unfavorable intermediate risk prostate cancer
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
- •High-risk or unfavorable intermediate-risk as defined below:
- •High-risk localized prostate cancer, as defined by any one of the following factors:
- •Pre-biopsy or any PSA ≥20 prior to enrollment, or Gleason score 8 or higher on any biopsy core, or cT3a or higher.
- •Unfavorable intermediate risk localized prostate cancer, as defined as any of the following factors:
- •Gleason score of 4+3 or higher on any biopsy core, or Gleason score 3+4 and >50% biopsy cores positive, or The presence of any two of the following: PSA>10, cT2b-c, Gleason score 3+4 in any core
- •No pelvic nodal metastases (based on CT or 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
- •KPS ≥ 70 (or ECOG 0-2)
- •Ability to understand, and willingness to sign, the written informed consent
排除标准
- •Patients with low-risk or favorable intermediate-risk prostate cancer do not meet inclusion criteria (these patients would be eligible for SBRT off-trial as a standard of care option)
- •Patients with any evidence of distant metastases
- •Hormonal therapy (LHRH agonist or oral anti-androgen) exceeding 7 months prior to registration
- •Prior cryosurgery, HIFU or brachytherapy of the prostate
- •Prior pelvic radiotherapy
- •History of Crohn's Disease or Ulcerative Colitis
研究组 & 干预措施
SBRT and ADT
Experimental
Patients undergo SBRT to a dose of 40 Gy in 5 fractions to prostate, and optional 25 Gy in 5 fractions to SVs and Pelvic LNs, with 9 months of Androgen Deprivation Therapy
干预措施: SBRT (Radiation)
SBRT and ADT
Experimental
Patients undergo SBRT to a dose of 40 Gy in 5 fractions to prostate, and optional 25 Gy in 5 fractions to SVs and Pelvic LNs, with 9 months of Androgen Deprivation Therapy
干预措施: Androgen deprivation therapy (ADT) (Drug)
结局指标
主要结局
progression free survival
时间窗: 5 years
progression is defined by biochemical (phoenix definition), clinical, or radiographic
次要结局
未报告次要终点
研究者
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