Safety and Efficacy of Salvage Lymph Node Dissection in Prostate Cancer Patients With Nodal Recurrence After Radical Prostatectomy With Curative Intent - a Prospective Single Center Phase I/II Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- The Prostate specific antigen value after 6 weeks.
研究概览
简要总结
Despite continuous technical improvements in urologic surgery, up to 40% of prostate cancer patients will develop biochemical recurrence after radical prostatectomy (RP), potentially because of micro metastasis at the time of the primary surgery.
With improved radiological modalities and nuclear medicine tracers like 68Ga-PSMA PET/CT, which allow the localization of the site of recurrence, there is increasing interest in metastasis directed therapies, such as salvage lymph node dissection.
The pelvic extended salvage lymph node dissection (sLND) is a promising option for treating prostate cancer patients with local recurrence after radical prostatectomy with curative intent. Several retrospective series has been published to determine the local value of sLND. Despite the first data seem to be feasible and promising, to date no prospective evaluation has been made. Thus sLND is still experimental according to the guidelines and is considered as an off label therapy.
This prospective single center phase I/II study was conducted to investigate the safety and early efficacy of salvage lymph node dissection in prostate cancer patients with local pelvic recurrence after radical prostatectomy (RP) with curative intention.
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer patients with lymph node metastasis in pelvic imaging
- •Status post radical prostatectomy with curative intent
- •Ability for informed consent
- •No sign for bone or visceral metastasis
- •Male > 18 years
- •ECOG performance status 0 or 1
排除标准
- •Male < 18 years
- •No ability for informed consent
- •Sign for bone or visceral metastasis
- •Deep venous thrombosis or pulmonary embolism within the last 6 months before study screening
- •ECOG performance status 2 or more
研究组 & 干预措施
Salvage lymph node dissection
Patients will undergo extended pelvic salvage lymph node dissection
干预措施: Salvage lymph node dissection (Procedure)
结局指标
主要结局
The Prostate specific antigen value after 6 weeks.
时间窗: 6 weeks
The rate of periperative complications within 90 days after surgery
时间窗: 90 days
次要结局
- Change in Prostate Specific Antigen doubling time(2 years)
- Time until development of castration resistance(2 years)
- Time until development of distant metastasis(2 years)
研究者
Dr. Bernhard Grubmüller
MD
Medical University of Vienna