Zhongshan Hospital, Fudan University
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- the time to castrate resistance
研究概览
简要总结
This study is to examine whether radical prostatectomy can impact survival and quality-of-life in men with oligo-metastatic prostate cancer.
详细描述
In this study, patients with oligo-metastatic prostate cancer will be randomized to radical prostatectomy plus standard care and standard care only. Standard care refers to androgen deprivation therapy (ADT) +/- other systemic therapies. Time to disease progression and post-treatment quality of life will be assessed and compared.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participants is willing and able to give informed consent for participation in the study
- •Male aged 19-75 years.
- •Diagnosed with oligo-metastatic prostate cancer (1-3 skeletal lesions on bone specific imaging, no visceral metastases).
- •Locally resectable tumor (clinical/radiological stage T1-T3).
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Suitable for radical prostatectomy within 12 months of starting standard care.
排除标准
- •Contraindications to radical prostatectomy.
- •Visceral metastases.
- •Prior radiotherapy to the abdomen/pelvis or to skeletal metastases.
- •Any systemic therapy of prostate cancer (including standard care) for 12 or more months prior to enrollment.
- •Current involvement in other interventional research.
研究组 & 干预措施
Intervention Group
Radical prostatectomy plus standard care
干预措施: Radical prostatectomy plus standard care (Procedure)
Intervention Group
Radical prostatectomy plus standard care
干预措施: Standard of care for metastatic prostate cancer (Drug)
Comparator Group
Standard care, currently ADT +/- other systemic therapies.
干预措施: Standard of care for metastatic prostate cancer (Drug)
结局指标
主要结局
the time to castrate resistance
时间窗: 36 months after randomization
The time to treatment failure defined as castrate resistance will be recorded via routine patient follow-up interviews.
次要结局
- Quality of life in patients post-randomization(three month post randomization)