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

N.N. Alexandrov National Cancer Centre

Status

Enrolling

Conditions

Prostate Cancer Patients Undergoing Radical Prostatectomy

Treatments

Procedure: Radical prostatectomy with limited / no lymph node dissection

Procedure: Radical prostatectomy with extended / limited lymph node dissection

Study type

Interventional

Funder types

Other

Identifiers

NCT07308990

011/25

Details and patient eligibility

About

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.

Enrollment

800 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.