RecruitingNot ApplicableNCT07308990

Limited Versus Extended Lymph Node Dissection During Radical Prostatectomy in Patients With Localized or Locally Advanced Prostate Cancer

To Develop and Implement a Method for Optimizing the Volume of Lymph Node Dissection in Radical Surgical Treatment of Localized or Locally Advanced Prostate Cancer


Sponsor

N.N. Alexandrov National Cancer Centre

Enrollment

800 participants

Start Date

Oct 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized controlled study assessing outcome of low (no or limited) versus high (limited or extended) extent of lymph node dissection in addition to radical prostatectomy in patients with operable localized or locally advanced prostate cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two surgical approaches for removing lymph nodes during prostate removal surgery (radical prostatectomy) — a limited dissection versus a more extensive extended dissection — to determine which approach leads to better cancer outcomes while minimizing side effects. **You may be eligible if...** - You are over 18 years old - You have a confirmed diagnosis of localized or locally advanced prostate cancer (adenocarcinoma) - There is no evidence that cancer has spread to distant parts of the body (no metastases) - Your tumor can be surgically removed based on imaging and physical exam - Your general health and life expectancy make you a suitable candidate for radical prostatectomy **You may NOT be eligible if...** - You have another active invasive cancer - You have a contraindication to pelvic lymph node dissection - You have already received treatments that conflict with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERadical prostatectomy with extended / limited lymph node dissection

In patients with NCCN high or unfavorable intermediate risk prostate cancer - radical prostatectomy with extended lymph node dissection (incl. external iliac, obturator, internal iliac and common iliac nodes up to ureter bilaterally). In patients with NCCN low or favorable intermediate risk prostate cancer - radical prostatectomy with limited lymph node dissection (incl. obturator + / - external iliac lymph nodes bilaterally).

PROCEDURERadical prostatectomy with limited / no lymph node dissection

In patients with NCCN high or unfavorable intermediate risk prostate cancer - radical prostatectomy with limited lymph node dissection (incl. obturator + / - external iliac lymph nodes bilaterally). In patients with NCCN low or favorable intermediate risk prostate cancer - radical prostatectomy with no lymph nodes dissection bilaterally.


Locations(1)

N.N. Alexandrov National Cancer Centre

Lyasny, Minsk Oblast, Belarus

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NCT07308990


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