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RECRUITING
NCT05109910
NA

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

Sponsor: The Netherlands Cancer Institute

View on ClinicalTrials.gov

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.

Official title: Prospective Randomized Controlled Trial To Evaluate The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

284

Start Date

2021-11-17

Completion Date

2027-11

Last Updated

2021-11-18

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Pelvic lymph node dissection

Bilateral extended pelvic lymph node dissection

Locations (1)

NKI-AVL

Amsterdam, Netherlands