The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy
Recruiting · NCT05109910 · Interventional (participants receive a specific treatment) · Lead sponsor: The Netherlands Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- NKI-AVL - Amsterdam, Netherlands