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

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

Trial Details

NCT ID
NCT07580196
Phase
NA
Sponsor
University of Turin, Italy
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Unilateral Extended Pelvic Lymph Node Dissection
  • Bilateral Extended Pelvic Lymph Node Dissection
Locations (sample)
  • Rozzano, Milano, Italy|45.38193,9.1559
  • Bologna, Italy|44.49381,11.33875
  • Florence, Italy|43.77925,11.24626
  • Foggia, Italy|41.45845,15.55188
  • Genova, Italy|45.21604,11.87211

Key Eligibility Criteria

  • Male patients aged 18 years or older
  • Histologically confirmed unilateral high-risk localized prostate cancer, defined by at least one of the following: ISUP Grade Group 4 or 5; suspici…
  • Unilateral features of the index lesion defined by biopsy, multiparametric MRI, and PSMA PET
  • No PSMA PET-positive pelvic lymph nodes contralateral to the dominant side of the prostate cancer

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Prostate Cancer Trials on Trialify →