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
N.N. Alexandrov National Cancer Centre
800 participants
Oct 29, 2025
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
Inclusion Criteria6
- 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 Criteria4
- 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.
Interventions
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).
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)
View Full Details on ClinicalTrials.gov
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NCT07308990