Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Acute Grade >2 Gastrointestinal Toxicity
研究概览
简要总结
This is a single-arm phase II prospective trials that is recruiting 100 participants. The study population that is being investigated are patients with localized high-risk or node-positive prostate cancer. Participants will receive external beam radiotherapy as a moderately hypofractionated boost to the prostate with pelvic radiation therapy. Androgen deprivation therapy will be prescribed at the discretion of the treating physician as per standard of care.
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
- •Age > 18 years.
- •Able to provide informed consent.
- •Histologic diagnosis of prostate adenocarcinoma.
- •ECOG performance status 0-
- •High-risk localized disease by NCCN criteria (>cT3, Grade group >4, or PSA >20 ng/mL) or clinical N1 disease.
- •Clinical M0 by conventional imaging (computed tomography (CT) and bone scan (BS)) and/or molecular imaging (prostate specific membrane antigen (PSMA)- positron emission tomography (PET))
排除标准
- •Prior pelvic radiotherapy.
- •Contraindications to radiotherapy
研究组 & 干预措施
Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation Therapy
External beam radiotherapy- 60 Gy in 20 fractions to the prostate, 48 Gy in 20 fractions to the pelvis, 68 Gy in 20 fraction optional boost to prostatic dominant intraprostatic lesion, 55 Gy in 20 fraction optional boost to involved pelvic lymph nodes
干预措施: Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy) (Radiation)
结局指标
主要结局
Acute Grade >2 Gastrointestinal Toxicity
时间窗: Baseline to 5-year follow-up
Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
次要结局
- Overall survival(Baseline to 5-year Follow-up)
- Patient-reported quality-of-life assessed by EPIC-26(Baseline to 5-year Follow-up)
- Graded criteria based on CTCAE version 5.0 for acute genitourinary toxicity and late genitourinary and gastrointestinal toxicity(Baseline to 5-year Follow-up)
- Measure the severity of lower urinary tract symptoms during the study(Baseline to 5-year Follow-up)
- Prostate cancer specific survival based on death from prostate cancer(Baseline to 5-year Follow-up)
- Measure of onocologic outcomes(Baseline to 5-year Follow-up)
- Measure of oncologic outcomes(Baseline to 5-year Follow-up)