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

Launched by THE NETHERLANDS CANCER INSTITUTE · Oct 25, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the impact of a specific surgical procedure called extended pelvic lymph node dissection (ePLND) in men with prostate cancer who are undergoing a radical prostatectomy (RP), which is surgery to remove the prostate gland. The trial aims to find out if performing ePLND provides any benefits for patients who have a low to moderate risk of cancer spreading to their lymph nodes. Many men may undergo this procedure without clear advantages, and the researchers want to better understand its role in treatment.

Eligible participants are men aged 18 and older with prostate cancer who have a calculated risk of lymph node involvement between 5% and 20% and show no signs of cancer spread on imaging tests. Those who join the trial will be randomly assigned to either have the ePLND or not during their RP. This means they might receive different treatment options to help determine what works best. Participants should be aware that, like any procedure, there may be risks involved, and they will need to provide their consent to take part in the study.

Gender

MALE

Eligibility criteria

• 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