Salvage Moderate Hypofractionated Versus Ultrahypofractionated Radiotherapy for Biochemical Recurrence After Radical Prostatectomy in Prostate Cancer: A Prospective, Multi-Center, Randomized Phase III Non- Inferiority Trial (HUB Trial)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- 5-year biochemical progression-free survival (bPFS)
研究概览
简要总结
This study is the first prospective, randomized phase III clinical trial designed to evaluate whether ultrahypofractionated radiotherapy is non-inferior to conventionally moderately hypofractionated radiotherapy in terms of efficacy, with acceptable toxicity, in patients who develop biochemical recurrence following radical prostatectomy.
Considering the potential clinical benefits of shorter treatment duration, cost reduction, and improved patient convenience, this study is expected to provide important evidence to optimize salvage radiotherapy strategies in routine clinical practice.
详细描述
Moderate hypofractionated radiotherapy (Moderate-hypoRT): 60 Gy in 24 fractions, delivered once daily, 5 days per week (on weekdays), over a total of 5-6 weeks.
Ultra-hypofractionated radiotherapy (Ultra-hypoRT): 31 Gy in 5 fractions, delivered every other day (2-3 fractions per week), over a total of 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients who have undergone radical prostatectomy for prostate cancer
- •Age ≥ 20 years
- •Persistent prostate-specific antigen (PSA) elevation after radical prostatectomy, defined as prostate-specific antigen (PSA) levels of 0.1-1.0 ng/mL with at least three consecutive increases
- •Patients who have undergone prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) for evaluation of prostate-specific antigen (PSA) elevation
- •Good performance status (ECOG performance status 0-1)
排除标准
- •Radiologic or clinical evidence of gross local recurrence, lymph node metastasis, or distant metastasis, including findings on prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT), as determined by the treating physician
- •Presence of lymph node metastasis or distant metastasis at the time of radical prostatectomy
- •History of prior pelvic radiotherapy
- •Diseases associated with a high risk of radiation toxicity (e.g., inflammatory bowel disease, systemic lupus erythematosus, scleroderma, or other connective tissue diseases)
- •History of another malignancy diagnosed or recurrent within the past 3 years (except for skin cancer and thyroid cancer)
- •Uncontrolled acute or chronic conditions deemed inappropriate for study participation by the investigator (e.g., dementia, Alzheimer's disease, cerebral infarction, etc.)
结局指标
主要结局
5-year biochemical progression-free survival (bPFS)
时间窗: 5 years after treatment completion
次要结局
- Analyze Distant Metastasis-Free Survival (DMFS)(5 years after treatment completion)
- Cancer-Specific Survival (CSS)(5 years after treatment completion)
- Overall Survival (OS)(5 years after treatment completion)
- Compare acute and late Genitourinary (GU) and Gastrointestinal (GI) toxicities.(5 years after treatment completion)
- Compare patient-reported Quality of Life (QoL) outcomes(During treatment and follow-up)
研究者
Won Park
Professor
Samsung Medical Center