Feasibility of Cytoreductive Prostatectomy in Men Newly Diagnosed With Metastatic Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- Rate of major peri-operative complications defined as Clavien-Dindo grade III or higher
研究概览
简要总结
This phase I trial studies the side effects of cytoreductive prostatectomy in treating patients with newly diagnosed prostate cancer that has spread from the primary site to other places in the body. Cytoreductive prostatectomy is a type of surgery that removes the prostate and as much of the tumor as possible. When combined with hormone therapy, robotic assisted radical prostatectomy (RARP) or conventional open retropubic radical prostatectomy (RRP) may prolong survival in patients with prostate cancer that has spread.
详细描述
PRIMARY OBJECTIVES:
I. To determine the safety and feasibility of cytoreductive prostatectomy (to remove as much of the primary cancer as possible) in men with newly diagnosed clinical T1-3N1M0 or T1-3N0M1a-b prostate cancer (herein, collectively referred to as metastatic prostate cancer).
SECONDARY OBJECTIVES:
I. Time to prostate specific antigen (PSA) nadir and castration resistance following cytoreductive prostatectomy and subsequent standard systemic therapy, androgen deprivation.
OUTLINE:
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
- •Histologically proven adenocarcinoma of the prostate
- •Evidence of lymph node or bone metastasis by magnetic resonance imaging (MRI)/computed tomography (CT), bone scan, or biopsy (N1Mx or NxM1)
- •Give informed consent
- •Clinical stage T3 or less (pelvic MRI shows no rectal and ureteral invasion)
- •Cleared by the primary medical doctor for surgery
- •No prior systemic therapy for metastatic prostate cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Refuses to give informed consent
- •Refuses or is unable to have pelvic MRI
- •Clinical stage T4 (pelvic MRI shows rectal and/or ureteral invasion)
- •Deemed a poor surgical risk per primary medical doctor
- •Received prior therapeutic intervention for metastatic prostate cancer
- •Known spinal cord compression or brain or liver metastasis
- •Deep vein thrombosis (DVT)/pulmonary embolism (PE) in the past 6 months
研究组 & 干预措施
Surgery followed by hormone therapy (ADT)
Patients undergo Robotic Assisted Radical Prostatectomy (RARP) or conventional open retropubic radical prostectomy (RRP). Immediately following surgery, patients receive the standard systemic androgen deprivation therapy.
干预措施: Robotic Assisted Radical Prostatectomy (Procedure)
Surgery followed by hormone therapy (ADT)
Patients undergo Robotic Assisted Radical Prostatectomy (RARP) or conventional open retropubic radical prostectomy (RRP). Immediately following surgery, patients receive the standard systemic androgen deprivation therapy.
干预措施: Conventional open retropubic radical prostectomy (Procedure)
Surgery followed by hormone therapy (ADT)
Patients undergo Robotic Assisted Radical Prostatectomy (RARP) or conventional open retropubic radical prostectomy (RRP). Immediately following surgery, patients receive the standard systemic androgen deprivation therapy.
干预措施: Laboratory Biomarker Analysis (Other)
Surgery followed by hormone therapy (ADT)
Patients undergo Robotic Assisted Radical Prostatectomy (RARP) or conventional open retropubic radical prostectomy (RRP). Immediately following surgery, patients receive the standard systemic androgen deprivation therapy.
干预措施: Quality-of-Life Assessment (Other)
Surgery followed by hormone therapy (ADT)
Patients undergo Robotic Assisted Radical Prostatectomy (RARP) or conventional open retropubic radical prostectomy (RRP). Immediately following surgery, patients receive the standard systemic androgen deprivation therapy.
干预措施: ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide) (Drug)
结局指标
主要结局
Rate of major peri-operative complications defined as Clavien-Dindo grade III or higher
时间窗: Within 90 days after cytoreductive prostatectomy
Rate will be calculated for the primary end point, and one-sided Binomial test will be used to compare the rate to the hypothesized value. Descriptive statistics will be provided. Any further statistical analysis deemed necessary to calculate significant findings will be done with the assistance of the Rutgers Cancer Institute of New Jersey Biostatistics Section.
次要结局
- Time to rising PSA while on the standard androgen deprivation therapy(Up to 3 years)
- Time to PSA nadir(Up to 3 years)
研究者
Isaac Yi Kim, MD, PhD, MBA
Associate Professor
Rutgers Cancer Institute of New Jersey