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

December 15, 2025 updated by: N.N. Alexandrov National Cancer Centre

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
    • Minsk Oblast
      • Lyasny, Minsk Oblast, Belarus, 223040

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age over 18 years.
  2. Histologically confirmed localized or locally advanced prostate cancer (adenocarcinoma without a neuroendocrine component).
  3. No evidence of metastatic spread of the tumor
  4. Local resectability of the tumor according to digital rectal examination and/or CT and/or MRI of the pelvis
  5. Patients are suitable for radical prostatectomy based on their comorbidities and life expectancy.
  6. Signed informed consent to participate in the study.

Exclusion Criteria:

  1. Presence of another active malignant invasive neoplasm.
  2. Contraindication to pelvic lymph node dissection (e.g., history of radiation therapy to the pelvis).
  3. The evidence of metastases in regional lymph nodes according to preoperative examination data (including PET/CT with PSMA).
  4. Severe concomitant disease limiting participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: no / limited lymph node dissection
Procedure: Radical 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.
Experimental: limited / extended lymph node dissection
Procedure: Radical 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metastasis-free survival
Time Frame: from enrollment to the end of the study at 5 years
time from randomization to first diagnosis of distant metastasis from prostate cancer
from enrollment to the end of the study at 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day complication rate
Time Frame: from the start of surgery to 30 days postoperatively
rate of complications from the start of surgery to 30 days postoperatively graded by Clavien-Dindo
from the start of surgery to 30 days postoperatively
Perioperative events (length of surgery, intraoperative blood loss)
Time Frame: perioperatively
perioperatively
Duration of hospital stay
Time Frame: at first follow up visit (6-12 weeks post-surgery)
time from surgery to the discharge from the hospital
at first follow up visit (6-12 weeks post-surgery)
Biochemical recurrence-free survival
Time Frame: from enrollment to the end of the study at 5 years
time from randomization to first confirmed PSA rise > / = 0.2 ng/ml
from enrollment to the end of the study at 5 years
Time to treatment
Time Frame: from enrollment to the end of the study at 5 years
time from randomization to the first prostate cancer-related therapy
from enrollment to the end of the study at 5 years
Prostate cancer specific survival
Time Frame: from enrollment to the end of the study at 5-7 years
time from randomization to death from prostate cancer
from enrollment to the end of the study at 5-7 years
Overall survival
Time Frame: from enrollment to the end of the study at 5-7 years
time from randomization to to death of any cause
from enrollment to the end of the study at 5-7 years
Metastasis-free survival in subgroups of patients (NCCN risk groups, operated by individual surgeon)
Time Frame: from enrollment to the end of the study at 5 years
time from randomization to first diagnosis of distant metastasis from prostate cancer
from enrollment to the end of the study at 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

N.N. Alexandrov National Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2025

Primary Completion (Estimated)

May 30, 2030

Study Completion (Estimated)

May 30, 2032

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 15, 2025

First Posted (Actual)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 011/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer Patients Undergoing Radical Prostatectomy

Clinical Trials on Radical prostatectomy with limited / no lymph node dissection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe