Health Trials

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

ConditionProstate Cancer Patients Undergoing Radical Prostatectomy
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Radical prostatectomy with extended / limited lymph node dissection

    Procedure/Surgery

    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 dissection

    Procedure/Surgery

    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.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: no / limited lymph node dissectionExperimental treatment 1 intervention
Group B: limited / extended lymph node dissectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

Perioperative events (length of surgery, intraoperative blood loss)

Time frame
perioperatively
3

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)
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

N.N. Alexandrov National Cancer Centre

Lead sponsor

Source ClinicalTrials.gov
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