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

NCT07308990 | Recruiting

• 1 other identifier: 011/25
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer Patients Undergoing Radical Prostatectomy

Keywords

prostate cancer; lymph node dissection; radical prostatectomy

Outcome Measures

Primary Outcomes (1)

• Metastasis-free survival

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

  from enrollment to the end of the study at 5 years

Secondary Outcomes (8)

• 30-day complication rate

  from the start of surgery to 30 days postoperatively

• Perioperative events (length of surgery, intraoperative blood loss)

  perioperatively

• Duration of hospital stay

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

• Biochemical recurrence-free survival

  from enrollment to the end of the study at 5 years

• Time to treatment

  from enrollment to the end of the study at 5 years

Study Arms (2)

no / limited lymph node dissection

EXPERIMENTAL

Procedure: Radical prostatectomy with limited / no lymph node dissection

limited / extended lymph node dissection

EXPERIMENTAL

Procedure: Radical prostatectomy with extended / limited lymph node dissection

Interventions

Radical prostatectomy with limited / no lymph node dissection PROCEDURE

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.

no / limited lymph node dissection

Radical prostatectomy with extended / limited lymph node dissection PROCEDURE

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).

limited / extended lymph node dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• N.N. Alexandrov National Cancer Centre: lead

Study Sites (1)

N.N. Alexandrov National Cancer Centre

Lyasny, Minsk Oblast, 223040, Belarus

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 30, 2025
• Study Start: October 29, 2025
• Primary Completion (Estimated): May 30, 2030
• Study Completion (Estimated): May 30, 2032
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

BE (1)