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

NCT05109910 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2021-11-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Pelvic lymph node dissection

Bilateral extended pelvic lymph node dissection

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Henk G van der Poel, Prof · The Netherlands Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-17
Primary Completion
2024-11-30
Completion
2027-11-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05109910 on ClinicalTrials.gov