Local Treatment With Radical Prostatectomy (RP) for Newly-diagnosed Metastatic Prostate Cancer (mPCa).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Time to first Disease Related Event
研究概览
简要总结
The objective of this study is to evaluate the role of local treatment with radical prostatectomy in patients with newly-diagnosed metastatic hormone-sensitive prostate cancer.
详细描述
Patients recently diagnosed with metastatic prostate cancer (mPCa), and meeting the eligibility criteria, will be given the opportunity to enroll in this study.
Study Groups:
After inclusion, patients requesting local treatment can undergo radical prostatectomy (RP) with pelvic lymph-node dissection (PLND) after multi-disciplinary evaluation. This resulting in a local treatment group and a no local treatment group. For ethical reasons, no randomization will be done.
Follow-up:
Patients not undergoing local treatment will undergo the current standard of care in our institution. And besides the intervention of local treatment, the other patients will receive this same current standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of prostate adenocarcinoma, confirmed by histology
- •Newly diagnosis of metastatic disease (stage TanyNanyM+)
- •Life expectancy ≥2y based on comorbid conditions, WHO performance status 0-2
- •Written informed consent, male ≥18yo
- •Willing and expected to comply with study protocol and follow-up schedule
- •Multidisciplinary Oncologic Consultation (MOC) approval
排除标准
- •Previous local or systemic treatment for prostate cancer
- •Metastatic brain disease, leptomeningeal disease or imminent spinal cord compression
- •Symptoms clearly related to metastatic lesions
- •Any other previous or current (malignant) disease which, in the judgment of the responsible physician, is likely to interfere with LoMP treatment or assessment
结局指标
主要结局
Time to first Disease Related Event
时间窗: up to 10 years
From date of inclusion until the date of any event related to local disease progression (eg ureter obstruction, bladder outlet obstruction), any Skeletal Related Event (SRE) or any event related to metastasis (eg lymphedema). \[months\]
Castration Refractory Prostate Cancer Progression-Free Survival
时间窗: up to 10 years
From date of inclusion until the date of Castration Refractory Prostate Cancer (CRPC) defined according to European Association of Urology (EAU) guidelines, or date of death from any cause, whichever came first, assessed up to 10 years. \[months\]
次要结局
- Overall Survival(at year 1 - 2 - 5)
- Quality of Life(at month 6 - 12)
- Time to Androgen Deprivation Therapy start(up to 10 years, estimated to occur within 24 months)
- Prostate Cancer Specific Survival(at year 1 - 2 - 5)