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NCT Number: NCT07308990

Limited Versus Extended Lymph Node Dissection During Radical Prostatectomy in Patients With 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.

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Key information

Conditions

Prostate Cancer Patients Undergoing Radical Prostatectomy Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radical prostatectomy with extended / limited lymph node dissection

Procedure

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).

Radical prostatectomy with limited / no lymph node dissection

Procedure

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 outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Perioperative events (length of surgery, intraoperative blood loss)

    Time frame: perioperatively

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

N.N. Alexandrov National Cancer Centre

Other Gov

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2030
Study completion
2032
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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