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

N.N. Alexandrov National Cancer Centre800 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

800

Conditions

Prostate Cancer Patients Undergoing Radical Prostatectomy

Interventions

Radical prostatectomy with extended / limited lymph node dissectionPROCEDURE

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 dissectionPROCEDURE

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age over 18 years. 2. Histologically confirmed localized or locally advanced prostate cancer (adenocarcinoma without a neuroendocrine component). 3. No evidence of metastatic spread of the tumor 4. Local resectability of the tumor according to digital rectal examination and/or CT and/or MRI of the pelvis 5. Patients are suitable for radical prostatectomy based on their comorbidities and life expectancy. 6. Signed informed consent to participate in the study. Exclusion Criteria: 1. Presence of another active malignant invasive neoplasm. 2. Contraindication to pelvic lymph node dissection (e.g., history of radiation therapy to the pelvis). 3. The evidence of metastases in regional lymph nodes according to preoperative examination data (including PET/CT with PSMA). 4. Severe concomitant disease limiting participation in the study.

Locations (1)

N.N. Alexandrov National Cancer Centre

Lyasny, Minsk Oblast, Belarus

RECRUITING

Outcomes

Primary Outcomes

Metastasis-free survival

time from randomization to first diagnosis of distant metastasis from prostate cancer

Time frame: from enrollment to the end of the study at 5 years

Secondary Outcomes

30-day complication rate

rate of complications from the start of surgery to 30 days postoperatively graded by Clavien-Dindo

Time frame: from the start of surgery to 30 days postoperatively

Perioperative events (length of surgery, intraoperative blood loss)

Time frame: perioperatively

Duration of hospital stay

time from surgery to the discharge from the hospital

Time frame: at first follow up visit (6-12 weeks post-surgery)

Biochemical recurrence-free survival

time from randomization to first confirmed PSA rise \> / = 0.2 ng/ml

Time frame: from enrollment to the end of the study at 5 years

Time to treatment

time from randomization to the first prostate cancer-related therapy

Time frame: from enrollment to the end of the study at 5 years

Prostate cancer specific survival

time from randomization to death from prostate cancer

Time frame: from enrollment to the end of the study at 5-7 years

Overall survival

time from randomization to to death of any cause

Time frame: from enrollment to the end of the study at 5-7 years

Data from ClinicalTrials.gov

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