Removing Lymph Nodes on One Side or Both Sides During Prostate Cancer Surgery
Compares two lymph node removal methods during surgery in men with high-risk prostate cancer.
Key facts
- Who runs it
- University of Turin, Italy
- Where
- Bologna, Florence, Foggia, Genova, Milan, Modena, Naples, Roma, Rozzano, Torino, and Verona, ItalySee the 14 sites
- Trial code
- Registry title
- Bilateral Versus Unilateral Lymph Node Dissection in High-Risk Prostate Cancer (BALANCE)
- Status
- Recruiting
- People taking part
- 820 people, planned
- Started
- 30 Mar 2026
- Expected to end
- Dec 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Unilateral Extended Pelvic Lymph Node Dissection
- Bilateral Extended Pelvic Lymph Node Dissection
- Record updated
- 12 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with high-risk prostate cancer on one side of the prostate who are going to have robot-assisted prostate removal surgery. It compares removing lymph nodes on one side of the pelvis with removing them on both sides.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- High-risk prostate cancer that has not spread beyond the prostate area (clinically localized) and sits mainly on one side, shown by biopsy, MRI and PSMA PET scan. At least one of these: ISUP Grade Group 4 or 5; suspected cT3a disease or higher on MRI and/or PSMA PET; or PSA of 20 ng/mL or more with a one-sided main tumour. No distant metastases. At most two PSMA-positive pelvic lymph nodes, only on the main side.
- Earlier treatment
- Must not have had any prostate cancer treatment before the surgery, such as hormone therapy, chemotherapy, radiotherapy or focal ablative therapy.
- Biomarker or test result
- PSMA PET shows no positive pelvic lymph nodes on the side opposite the main tumour, and no significant PSMA uptake (PRIMARY score 3 to 5) on that side.
Main reasons for not taking part
- Prostate cancer with ISUP Grade Group 4 to 5 on the opposite side
- N1 or M1 disease (spread to lymph nodes or distant sites), except up to two positive pelvic lymph nodes on the main side
- Another active cancer
- Cannot have MRI or PSMA PET, or has any reason that rules out pelvic lymph node dissection
- ASA score above 3, or inadequate blood or clotting function
The registry criteria, word for word
Show all 32 criteriaShow less
Who can take part
- 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; suspicion of at least cT3a disease on multiparametric MRI and/or PSMA PET; or PSA greater than or equal to 20 ng/mL with a unilateral index lesion
- 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
- No significant contralateral PSMA uptake on the non-dominant side, defined as lesions with PRIMARY score 3 to 5
- No contralateral index lesion on multiparametric MRI subsequently confirmed by prostate biopsy
- No high-risk histology on the side contralateral to the dominant lesion, including ISUP Grade Group greater than 3 or unconventional prostate cancer histology
- No frank extracapsular invasion or 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 are allowed on the contralateral side
- A maximum of two pelvic PSMA-positive lymph nodes allowed on the dominant side
- Clinically localized disease, defined as less than cT4 on multiparametric MRI and no distant metastases, including no retroperitoneal lymph nodes on PSMA PET
- Life expectancy greater than 10 years according to physician judgment
- Scheduled for robot-assisted radical prostatectomy and fit for surgery
- Written informed consent provided
Who cannot take part
- Any prostate cancer treatment prior to prostatectomy, including androgen deprivation therapy, neoadjuvant chemotherapy, radiotherapy, or focal ablative therapy
- Prior active treatment for prostate cancer
- Contralateral ISUP Grade Group 4 to 5 prostate cancer
- Contralateral cT3 disease on multiparametric MRI
- N1 or M1 disease on PSMA PET or multiparametric MRI, except for up to two positive pelvic lymph nodes on the dominant side
- Other active malignancy
- Severe psychiatric disease
- Active infection
- Any other serious medical, psychiatric, psychological, familial, or geographic condition that, in the judgment of the investigator, may interfere with staging, treatment, follow-up, compliance, or increase treatment-related risk
- Patients with prior malignancy treated with curative intent are eligible only with mandatory approval by the local multidisciplinary tumor board
- Age younger than 18 years
- Contralateral ISUP Grade Group 2 in more than 4 positive cores or ISUP Grade Group 3 in more than 2 positive cores
- No systematic prostate biopsies performed, with a minimum of 10 cores, and targeted biopsies when a target lesion is present
- Contraindication to multiparametric MRI and/or PSMA PET
- Inability to provide written informed consent
- ASA score greater than 3
- Any contraindication to pelvic lymph node dissection
- Inadequate hematologic and/or coagulation function
Where in Italy
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola-Malpighi & University of BolognaBologna, ItalyContact: Giovanni Olivieri, MDNot yet recruiting
- Università degli Studi di Firenze / AOU CareggiFlorence, ItalyContact: Francesco Sessa, MDNot yet recruiting
- Università degli Studi di Foggia / AO Ospedali Riuniti di FoggiaFoggia, ItalyContact: Ugo Falagario, MDNot yet recruiting
- IRCCS Ospedale Policlinico San Martino & University of GenoaGenova, ItalyContact: Francesca Ambrosini, MDNot yet recruiting
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyContact: Stefano Tappero, MDNot yet recruiting
- IEO Istituto Europeo di OncologiaMilan, ItalyContact: Laura Adamoli, MDNot yet recruiting
- Università degli Studi di Modena / AOU ModenaModena, ItalyContact: Natal Rodriguez, MDNot yet recruiting
- Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"Naples, ItalyContact: Eleonora MonteleoneNot yet recruiting
- IFO - Istituti Fisioterapici OspitalieriRoma, ItalyContact: Federica StrugliaNot yet recruiting
- Policlinico Universitario Gemelli IRCCS & Università Cattolica del Sacro CuoreRoma, ItalyContact: Maria Chiara Sighinolfi, MDNot yet recruiting
- Università Tor Vergata / Policlinico Tor VergataRoma, ItalyContact: Simone Albisinni, MDNot yet recruiting
- Humanitas Clinical and Research Centre & Humanitas UniversityRozzano, ItalyContact: Massimo Lazzeri, MDNot yet recruiting
- AOU Città della Salute e della Scienza di Torino - Ospedale MolinetteTorino, ItalyContact: Chiara FiameniTaking people
- Università degli Studi di Verona / AOU VeronaVerona, ItalyContact: Sarah MalandraNot yet recruiting
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Unilateral Extended PLNDTreatment being tested
Extended pelvic lymph node dissection performed only on the side of the dominant prostate cancer lesion during robot-assisted radical prostatectomy.
Treatment: Unilateral Extended Pelvic Lymph Node Dissection
- Bilateral Extended PLNDExisting treatment, for comparison
Extended pelvic lymph node dissection performed bilaterally during robot-assisted radical prostatectomy.
Treatment: Bilateral Extended Pelvic Lymph Node Dissection
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Bilateral or Unilateral Extended Pelvic Lymph Node Dissection in High-Risk Prostate Cancer: The BALANCE Randomized Controlled Trial
- Plain-language title
- Removing Lymph Nodes on One Side or Both Sides During Prostate Cancer SurgeryGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 12 May 2026