RecruitingNot Applicable

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

Belarus800 participantsStarted 2025-10-29

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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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.

What they're measuring

Metastasis-free survival

Timeframe: from enrollment to the end of the study at 5 years

Trial details

NCT IDNCT07308990

SponsorN.N. Alexandrov National Cancer Centre

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2030-05-30

View on ClinicalTrials.gov More Prostate Cancer Patients Undergoing Radical Prostatectomy trials