Tests whether removing pelvic lymph nodes helps men after prostate surgery
Compares prostate surgery with or without lymph node removal in men with prostate cancer.
Plain-language title generated from the registry record
Registry title: The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy
Key facts
- Where
- Amsterdam, NetherlandsSee the site
Where in Netherlands
- NKI-AVLAmsterdam, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Netherlands Cancer Institute
- Trial code
- NCT05109910
- Record updated
- 18 November 2021
- Original description
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.Read full original descriptionShow less
Prospective Randomized Controlled Trial To Evaluate The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy
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.
Inclusion: 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.
Exclusion: Neoadjuvant hormone deprivation therapy; American Society of Anaesthesiology (ASA) classification > 3; Patients with a contradiction for a lymphadenectomy; Absence or withdrawal of an informed consent; Evidence of metastases on pre-operative PSMA PET/CT.