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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorN.N. Alexandrov National Cancer Centre

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Radical prostatectomy with extended / limited lymph node dissection
  • Radical prostatectomy with limited / no lymph node dissection

Treatment groups

800 Participants
are divided into 2 treatment groups