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Recruiting NCT07308990

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

No phase Interventional Prostate Cancer Patients Undergoing Radical Prostatectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radical prostatectomy with extended / limited lymph node dissection, Radical prostatectomy with limited / no lymph node dissection.
Who it may be relevant to
Registry conditions: Prostate Cancer Patients Undergoing Radical Prostatectomy. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belarus
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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).
  • 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.

Primary outcome measures

  • Metastasis-free survival [Time frame: from enrollment to the end of the study at 5 years]
Secondary outcome measures (8)
  • 30-day complication rate [Time frame: from the start of surgery to 30 days postoperatively]
  • Perioperative events (length of surgery, intraoperative blood loss) [Time frame: perioperatively]
  • Duration of hospital stay [Time frame: 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 to treatment [Time frame: 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]
  • Overall survival [Time frame: 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Belarus · 1 center
  • N.N. Alexandrov National Cancer Centre — Lyasny

Identifiers

NCT: NCT07308990 · 011/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗