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Bilateral Versus Unilateral Lymph Node Dissection in High-Risk Prostate Cancer (BALANCE)

NCT07580196 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 820

Last updated 2026-05-12

No results posted yet for this study

Summary

BALANCE is a multicenter, prospective, randomized controlled trial enrolling men with unilateral high-risk localized prostate cancer identified by prostate biopsy, multiparametric MRI, and PSMA PET imaging. Eligible patients scheduled for robot-assisted radical prostatectomy will be randomized in a 1:1 ratio to undergo either unilateral extended pelvic lymph node dissection or bilateral extended pelvic lymph node dissection.

Pelvic lymph node dissection is commonly performed in high-risk prostate cancer for staging purposes, but its therapeutic benefit remains uncertain and the procedure may increase operative time, costs, and postoperative morbidity. Modern imaging techniques may improve the identification of patients with predominantly unilateral disease and support a more selective surgical approach.

The co-primary objectives are to compare 3-year biochemical recurrence-free survival and early postoperative PSA persistence between the two surgical strategies. Secondary objectives include comparison of perioperative complications, operative time, blood loss, length of hospital stay, quality of life, long-term oncologic outcomes, and costs.

This study is designed to determine whether unilateral extended pelvic lymph node dissection can reduce surgical morbidity while preserving oncologic outcomes in appropriately selected patients with high-risk prostate cancer.

Conditions

Interventions

PROCEDURE

Unilateral Extended Pelvic Lymph Node Dissection

Extended pelvic lymph node dissection performed only on the side of the dominant lesion, as defined by biopsy, multiparametric MRI, and PSMA PET findings.

PROCEDURE

Bilateral Extended Pelvic Lymph Node Dissection

Extended pelvic lymph node dissection performed bilaterally according to the study surgical template during robot-assisted radical prostatectomy.

Sponsors & Collaborators

  • AIRC (Italian Association for Cancer Research)

    collaborator UNKNOWN

  • Fondazione Ricerca Molinette

    collaborator UNKNOWN

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Giancarlo Marra, MD · Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-30
Primary Completion
2029-12-31
Completion
2030-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07580196 on ClinicalTrials.gov