Condition: Prostate Cancer · Sponsor: University of Turin, Italy
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.
This description comes directly from the study's public registry record.
Chiara Fiameni · +39 011 633 6591 · chiara.fiameni@unito.it
Alessandro Marquis, MD · +39 011 633 6591 · alessandro.marquis@unito.it
Always discuss trial participation with your own doctor first.
| Humanitas Clinical and Research Centre & Humanitas University | Rozzano, Milano, Italy | Not Yet Recruiting |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola-Malpighi & University of Bologna | Bologna, Italy | Not Yet Recruiting |
| Università degli Studi di Firenze / AOU Careggi | Florence, Italy | Not Yet Recruiting |
| Università degli Studi di Foggia / AO Ospedali Riuniti di Foggia | Foggia, Italy | Not Yet Recruiting |
| IRCCS Ospedale Policlinico San Martino & University of Genoa | Genova, Italy | Not Yet Recruiting |
| IEO, Istituto Europeo di Oncologia | Milan, Italy | Not Yet Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda | Milan, Italy | Not Yet Recruiting |
| Università degli Studi di Modena / AOU Modena | Modena, Italy | Not Yet Recruiting |
| Istituto Nazionale Tumori, IRCCS, Fondazione "G. Pascale" | Naples, Italy | Not Yet Recruiting |
| Università Tor Vergata / Policlinico Tor Vergata | Roma, Italy | Not Yet Recruiting |
| IFO - Istituti Fisioterapici Ospitalieri | Roma, Italy | Not Yet Recruiting |
| Policlinico Universitario Gemelli IRCCS & Università Cattolica del Sacro Cuore | Roma, Italy | Not Yet Recruiting |
+ 2 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07580196