Actively Recruiting
Bilateral Versus Unilateral Lymph Node Dissection in High-Risk Prostate Cancer (BALANCE)
Led by University of Turin, Italy · Updated on 2026-05-12
820
Participants Needed
14
Research Sites
243 weeks
Total Duration
On this page
Sponsors
U
University of Turin, Italy
Lead Sponsor
A
AIRC (Italian Association for Cancer Research)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Bilateral Versus Unilateral Lymph Node Dissection in High-Risk Prostate Cancer (BALANCE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 years or older
- Diagnosed with unilateral high-risk localized prostate cancer by biopsy, multiparametric MRI, and PSMA PET
- Unilateral features of the index lesion confirmed by biopsy, MRI, and PSMA PET
- No PSMA PET-positive pelvic lymph nodes on the side opposite the dominant lesion
- No significant PSMA uptake or index lesion on the non-dominant side
- No high-risk histology or extracapsular/seminal vesicle invasion on the contralateral side
- Up to two positive systematic cores with unfavorable intermediate-risk disease or up to four with favorable intermediate-risk disease allowed on the contralateral side
- Maximum of two pelvic PSMA-positive lymph nodes on the dominant side
- Clinically localized disease (less than cT4) without distant metastases
- Life expectancy over 10 years
- Scheduled for robot-assisted radical prostatectomy and fit for surgery
- Provided written informed consent
You will not qualify if you...
- Any prior prostate cancer treatment before prostatectomy, including hormone therapy, chemotherapy, radiotherapy, or focal therapy
- Contralateral ISUP Grade Group 4 or 5 prostate cancer
- Contralateral ISUP Grade Group 2 in more than 4 positive biopsy cores or Grade Group 3 in more than 2 cores
- Contralateral cT3 disease on multiparametric MRI
- N1 or M1 disease on PSMA PET or MRI, except up to two positive pelvic lymph nodes on the dominant side
- No systematic prostate biopsies performed with at least 10 cores
- Other active cancers
- Contraindications to multiparametric MRI or PSMA PET
- Unable to provide written informed consent
- Age under 18 years
- ASA score greater than 3
- Contraindications to pelvic lymph node dissection
- Severe psychiatric illness
- Poor hematologic or coagulation function
- Active infection
- Any other serious medical, psychiatric, psychological, familial, or geographic condition that may interfere with study participation or increase risk
- Prior malignancy treated with curative intent without multidisciplinary tumor board approval
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Trial Site Locations
Total: 14 locations
1
Humanitas Clinical and Research Centre & Humanitas University
Rozzano, Milano, Italy, 20089
Not Yet Recruiting
2
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola-Malpighi & University of Bologna
Bologna, Italy, 40138
Not Yet Recruiting
3
Università degli Studi di Firenze / AOU Careggi
Florence, Italy, 50134
Not Yet Recruiting
4
Università degli Studi di Foggia / AO Ospedali Riuniti di Foggia
Foggia, Italy, 71122
Not Yet Recruiting
5
IRCCS Ospedale Policlinico San Martino & University of Genoa
Genova, Italy, 16132
Not Yet Recruiting
6
IEO, Istituto Europeo di Oncologia
Milan, Italy, 20141
Not Yet Recruiting
7
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Not Yet Recruiting
8
Università degli Studi di Modena / AOU Modena
Modena, Italy, 41124
Not Yet Recruiting
9
Istituto Nazionale Tumori, IRCCS, Fondazione "G. Pascale"
Naples, Italy, 80131
Not Yet Recruiting
10
Università Tor Vergata / Policlinico Tor Vergata
Roma, Italy, 00133
Not Yet Recruiting
11
IFO - Istituti Fisioterapici Ospitalieri
Roma, Italy, 00144
Not Yet Recruiting
12
Policlinico Universitario Gemelli IRCCS & Università Cattolica del Sacro Cuore
Roma, Italy, 00168
Not Yet Recruiting
13
AOU Città della Salute e della Scienza di Torino, Ospedale Molinette
Torino, Italy, 10126
Actively Recruiting
14
Università degli Studi di Verona / AOU Verona
Verona, Italy, 37134
Not Yet Recruiting
Research Team
C
Chiara Fiameni
CONTACT
A
Alessandro Marquis, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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