Prospective Randomized Controlled Trial To Evaluate The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Persistent PSA rate
研究概览
简要总结
An extended pelvic lymph node dissection (ePLND) is the most accurate staging method to assess the presence of lymph node metastases in prostate cancer (PCa) patients. The therapeutic value, however remains unclear. Prospective randomized trials to address this void are lacking. Since in intermediate and a proportion of high risk PCa the risk of nodal metastases is generally below 25%, the vast majority of men undergo a procedure that has no oncological benefit, but is not without toxicity.
Therefore, the investigators aim to compare the oncologic outcomes of intermediate- and high-risk PCa patients with an estimated risk of lymph node invasion of 5-20% undergoing a radical prostatectomy (RP) with or without an ePLND.
详细描述
The role of an extended pelvic lymph node dissection (ePLND) in patients undergoing radical prostatectomy (RP) remains controversial. An ePLND is the most accurate staging method to assess the presence of lymph node metastases. Lymph node involvement is associated with a significantly worse prognosis and may require immediate or delayed adjuvant therapy. However, an ePLND is associated with an increased risk of complications such as lymphoceles, thromboses and lymphedema, and prolongs surgery and patient recovery. Thus, the diagnostic advantage of PLND should be weighed against the potential morbidity.
The therapeutic value of an ePLND remains especially unclear in PCa patients with an estimated risk of lymph node invasion (LNI) ≤ 20%, where only a minority of patients will have nodes harbouring metastases. Prospective trials to address this issue are still lacking.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, aged ≥ 18 years
- •Prostate cancer patients with a Briganti calculated risk of LN metastases of 5-20% without evidence of metastases on Prostate-Specific Membrane Antigen (PSMA) PET/CT requiring an ePLND in the standard treatment
- •Scheduled for a (robot-assisted) laparoscopic radical prostatectomy
- •Written informed consent
排除标准
- •American Society of Anaesthesiology (ASA) classification > 3
- •Patients with a contradiction for a lymphadenectomy
- •Neoadjuvant hormone deprivation therapy
- •Absence or withdrawal of an informed consent
- •Evidence of metastases on pre-operative PSMA PET/CT
研究组 & 干预措施
Radical prostatectomy with an extended pelvic lymph node dissection
According to the standard of care, patients in this arm will receive a radical prostatectomy with a standard bilateral ePLND. This includes the removal of lymph nodes within the obturator fossa and bilateral to the external iliac artery, internal iliac artery and common iliac artery up to the ureteral-vessel crossing.
干预措施: Pelvic lymph node dissection (Procedure)
Radical prostatectomy without an extended pelvic lymph node dissection
Patients in this arm will undergo a radical prostatectomy without a bilateral extended pelvic lymph node dissection. In case of intraoperatively found suspicious lymph nodes, a lymphadenectomy is performed. According to the intention to treat principle, patients with intraoperatively removed lymph nodes remain included in the study.
结局指标
主要结局
Persistent PSA rate
时间窗: 6 months after surgery
Persistent PSA is defined as a PSA value ≥ 0.1 ng/ml after radical prostatectomy
次要结局
- Biochemical recurrence (BCR) rate(3 years after surgery)
- Metastasis-free survival(3 years after surgery)
- Incidence of complications after surgery(3 and 6 months after surgery)
- Incidence of salvage therapy after primary surgery(3 years after surgery)
- Global Quality of life after surgery(6, 12, 24 and 36 months after surgery)
- Health-related quality of life of patients with prostate cancer(6, 12, 24 and 36 months after surgery)
- Urinary continence after surgery(6, 12, 24 and 36 months after surgery)
- Urinary voiding symptoms(6, 12, 24 and 36 months after surgery)
- Potency after surgery(6, 12, 24 and 36 months after surgery)