Evaluating the Efficacy and Safety of Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- rPFS
研究概览
简要总结
To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy combined with cytoreductive prostatectomy (CRP)
详细描述
To investigate the multimodality approaches for mHSPC
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
- •Male aged ≥18 and ≤75;
- •Histologically confirmed prostate adenocarcinoma;
- •Evidence of metastasis confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histology;
- •Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (visceral organ metastasis);
- •Prostate cancer has not received local treatment (e.g., prostate radiotherapy, cryotherapy, etc.);
- •The surgeon believes the prostate can be removed;
排除标准
- •The surgeon believes the disease is unresectable;
- •Life expectancy less than 2 years;
- •Active spinal cord compression;
- •History of prior local treatment for prostate cancer;
- •Difficulty swallowing, chronic diarrhea, intestinal obstruction, and other factors affecting drug intake and absorption;
- •Refusal to sign the informed consent;
- •Investigator believes the individual is not suitable for inclusion.
研究组 & 干预措施
Local treatment group
Triplet or doublet therapy followed by cytoreductive prostatectomy or brachytherapy
干预措施: Cytoreductive prostatectomy or brachytherapy (Procedure)
SOC group
Triplet or doublet therapy (ie. docetaxel/abiraterone, apalutamide，Rezvilutamide，darolutamide，enzalutamide)
干预措施: ADT+second-generation antiandrogens ± chemotherapy (Drug)
结局指标
主要结局
rPFS
时间窗: 3 year
Assess how long a cancer patient lives without any signs of progression of their disease, as determined by radiographic evidence
次要结局
- Safety of CRP in mHSPC patients(until one year after the local therapy)
研究者
Hua Lixin
Clinical Professor
The First Affiliated Hospital with Nanjing Medical University