The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy

Recruiting now · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT05109910

Run by

The Netherlands Cancer Institute

People needed

284

Starts

2021-11-17

Expected to finish

2027-11-01

Last updated by the study team

2021-11-18

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• NKI-AVL — Amsterdam, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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