Prostate CancerBALANCENCT07580196
Bilateral Versus Unilateral Lymph Node Dissection in High-Risk Prostate Cancer (BALANCE)
A study testing Unilateral Extended Pelvic Lymph Node Dissection and Bilateral Extended Pelvic Lymph Node Dissection in people with Prostate Cancer, run by University of Turin, Italy at 14 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Unilateral Extended Pelvic Lymph Node Dissection and Bilateral Extended Pelvic Lymph Node Dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 820 participants
- Where
- 14 sitesItaly
- Study dates
- 30 Mar 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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 join
- 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 ISUP Grade Group 2 in more than 4 positive cores or ISUP Grade Group 3 in more than 2 positive cores
- 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
Show all 18Show fewer
- No systematic prostate biopsies performed, with a minimum of 10 cores, and targeted biopsies when a target lesion is present
- Other active malignancy
- Contraindication to multiparametric MRI and/or PSMA PET
- Inability to provide written informed consent
- Age younger than 18 years
- ASA score greater than 3
- Any contraindication to pelvic lymph node dissection
- Severe psychiatric disease
- Inadequate hematologic and/or coagulation function
- 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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Italy14 sites, 14 recruiting
- Not yet recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola-Malpighi & University of Bologna
Bologna, 40138
Giovanni Olivieri, MD, +39 0512142373, giovanni.olivieri@aosp.bo.it
Lorenzo Bianchi, MD
- Not yet recruiting
Università degli Studi di Firenze / AOU Careggi
Florence, 50134
Francesco Sessa, MD, +39 0552758011, francesco.sessa@unifi.it
Francesco Sessa, MD
- Not yet recruiting
Università degli Studi di Foggia / AO Ospedali Riuniti di Foggia
Foggia, 71122
Ugo Falagario, MD, +39 0881 732111, ugo.falagario@unifg.it
Ugo Falagario, MD
- Not yet recruiting
IRCCS Ospedale Policlinico San Martino & University of Genoa
Genova, 16132
Francesca Ambrosini, MD, +39 010 555 3473, f.ambrosini@gmail.com
Matteo Bauckneht, MD
- Not yet recruiting
IEO, Istituto Europeo di Oncologia
Milan, 20141
Laura Adamoli, MD, +39 02 57489 1, laura.adamoli@ieo.it
Ettore Di Trapani, MD
- Not yet recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Stefano Tappero, MD, +39 02 6444 7896, stefano.tappero@ospedaleniguarda.it
Paolo Dell'Oglio, MD
- Not yet recruiting
Università degli Studi di Modena / AOU Modena
Modena, 41124
Natal Rodriguez, MD, +39 059 3962138, natlrodriguez647@gmail.com
Stefano Puliatti, MD
- Not yet recruiting
Istituto Nazionale Tumori, IRCCS, Fondazione "G. Pascale"
Naples, 80131
Eleonora Monteleone, +39 0815903416, eleonora.monteleone@istitutotumori.na.it
Gianluca Spena, MD
- Not yet recruiting
Università Tor Vergata / Policlinico Tor Vergata
Roma, 00133
Simone Albisinni, MD, +39 06 2090 2975, simone.albisinni@uniroma2.it
Simone Albisinni, MD
- Not yet recruiting
IFO - Istituti Fisioterapici Ospitalieri
Roma, 00144
Federica Struglia, +39 06 52666217, federica.struglia@ifo.it
Giuseppe Simone, MD
- Not yet recruiting
Policlinico Universitario Gemelli IRCCS & Università Cattolica del Sacro Cuore
Roma, 00168
Maria Chiara Sighinolfi, MD, +39 06 3015 5290, mariachiara.sighinolfi@policlinicogemelli.it
Bernardo Maria Cesare Rocco, MD
- Not yet recruiting
Humanitas Clinical and Research Centre & Humanitas University
Rozzano, Milano, 20089
Massimo Lazzeri, MD, +39 0282241, massimo.lazzeri@humanitas.it
Giovanni Lughezzani, MD
- Recruiting
AOU Città della Salute e della Scienza di Torino, Ospedale Molinette
Torino, 10126
Chiara Fiameni, +39 011 633 6591, chiara.fiameni@unito.it
Alessandro Marquis, MD, +39 011 633 6591, alessandro.marquis@unito.it
- Not yet recruiting
Università degli Studi di Verona / AOU Verona
Verona, 37134
Sarah Malandra, +39 0458122178, sarah.malandra@univr.it
Riccardo Bertolo, MD
About this study
Official title: Bilateral or Unilateral Extended Pelvic Lymph Node Dissection in High-Risk Prostate Cancer: The BALANCE Randomized Controlled Trial
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.
Read more
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
- Prostate Cancer
- Being tested
- Unilateral Extended Pelvic Lymph Node Dissection, Bilateral Extended Pelvic Lymph Node Dissection
- Keywords
- Pelvic Lymph Node Dissection, Radical Prostatectomy, PSMA PET, mpMRI, Randomized Controlled Trial, High-Risk Prostate Cancer, Unilateral Lymph Node Dissection, Bilateral Lymph Node Dissection
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral Extended Pelvic Lymph Node DissectionProcedure or surgery
Extended pelvic lymph node dissection performed only on the side of the dominant lesion, as defined by biopsy, multiparametric MRI, and PSMA PET findings.
Bilateral Extended Pelvic Lymph Node DissectionProcedure or surgery
Extended pelvic lymph node dissection performed bilaterally according to the study surgical template during robot-assisted radical prostatectomy.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Extended PLND | Experimental | Extended pelvic lymph node dissection performed only on the side of the dominant prostate cancer lesion during robot-assisted radical prostatectomy. Receives: Procedure: Unilateral Extended Pelvic Lymph Node Dissection |
| Bilateral Extended PLND | Active comparator | Extended pelvic lymph node dissection performed bilaterally during robot-assisted radical prostatectomy. Receives: Procedure: Bilateral Extended Pelvic Lymph Node Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Recurrence-Free Survival
Biochemical recurrence defined as postoperative PSA greater than 0.1 ng/mL with three consecutive rises or initiation of prostate cancer-specific secondary treatment more than 6 months after surgery
Measured: 3 years after surgery
PSA Persistence
Postoperative PSA greater than 0.1 ng/mL at 6 weeks after surgery confirmed by an additional PSA measurement performed 2 weeks later.
Measured: 8 weeks after surgery
Secondary outcomes (9)
Perioperative Complications
Complications graded using the Clavien-Dindo classification and assessed for likelihood of being related to pelvic lymph node dissection.
Measured: Up to 6 months after surgery
Operative Time
Total operative time recorded during robot-assisted radical prostatectomy and pelvic lymph node dissection.
Measured: During surgery
Estimated Blood Loss
Intraoperative estimated blood loss.
Measured: During surgery
Length of Hospital Stay
Number of days from surgery to discharge from the index hospitalization.
Measured: During the index hospitalization, up to 90 days after surgery
Overall Prostate Cancer Quality of Life Score Assessed Using the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)
Overall prostate cancer-related quality of life assessed using the Expanded Prostate Cancer Index Composite for Clinical Practice questionnaire. The overall score is calculated by summing the five domain summary scores: urinary incontinence, urinary irritation/obstruction, bowel, sexual, and vitality/hormonal. Total scores range from 0 to 60, with higher scores indicating worse symptoms and poorer quality of life.
Measured: 1 year after surgery
Treatment-Free Survival
Absence of any salvage local or systemic treatment after surgery.
Measured: 3 years after surgery
Systemic Treatment-Free Survival
Absence of systemic treatment after surgery.
Measured: 3 years after surgery
Metastasis-Free Survival
Absence of metastatic disease during follow-up, including PSMA PET assessment when clinically indicated after multidisciplinary discussion.
Measured: 3 years after surgery
Cost-Effectiveness
Cost-effectiveness assessed as incremental cost per quality-adjusted life year at 1 year after surgery.
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start30 Mar 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with unilateral high-risk localized prostate cancer 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.
- Masking
- None (open label)
- Enrolment
- 820 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro, Fondazione Ricerca Molinette
- Responsible party
- Principal investigator, Giancarlo Marra, University of Turin, Italy
- Investigators
- Giancarlo Marra, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580196
- Sponsor's protocol ID
- BALANCE_UTORINO_2026
- Acronym
- BALANCE
- Status last verified
- May 2026
- First submitted
- 20 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data sharing plan is currently available.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral or Unilateral Extended Pelvic Lymph Node Dissection in High-Risk Prostate Cancer: The BALANCE Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07580196
- Acronym / sponsor ID
- BALANCE / BALANCE_UTORINO_2026
- Conditions
- Prostate Cancer
- Keywords
- Pelvic Lymph Node Dissection, Radical Prostatectomy, PSMA PET, mpMRI, Randomized Controlled Trial, High-Risk Prostate Cancer, Unilateral Lymph Node Dissection, Bilateral Lymph Node Dissection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 820 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro, Fondazione Ricerca Molinette
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with unilateral high-risk localized prostate cancer 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.
| Arm | Type | Receives |
|---|---|---|
| Unilateral Extended PLND | Experimental | Procedure: Unilateral Extended Pelvic Lymph Node DissectionExtended pelvic lymph node dissection performed only on the side of the dominant prostate cancer lesion during robot-assisted radical prostatectomy. |
| Bilateral Extended PLND | Active comparator | Procedure: Bilateral Extended Pelvic Lymph Node DissectionExtended pelvic lymph node dissection performed bilaterally during robot-assisted radical prostatectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (18 listed)
- 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 ISUP Grade Group 2 in more than 4 positive cores or ISUP Grade Group 3 in more than 2 positive cores
- Contralateral cT3 disease on multiparametric MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unilateral Extended Pelvic Lymph Node DissectionExtended pelvic lymph node dissection performed only on the side of the dominant lesion, as defined by biopsy, multiparametric MRI, and PSMA PET findings. | Procedure or surgery | Unilateral Extended PLND |
| Bilateral Extended Pelvic Lymph Node DissectionExtended pelvic lymph node dissection performed bilaterally according to the study surgical template during robot-assisted radical prostatectomy. | Procedure or surgery | Bilateral Extended PLND |
Primary outcome
Biochemical Recurrence-Free Survival
Time frame: 3 years after surgery
Biochemical recurrence defined as postoperative PSA greater than 0.1 ng/mL with three consecutive rises or initiation of prostate cancer-specific secondary treatment more than 6 months after surgery
PSA Persistence
Time frame: 8 weeks after surgery
Postoperative PSA greater than 0.1 ng/mL at 6 weeks after surgery confirmed by an additional PSA measurement performed 2 weeks later.
9 secondary outcomes
Perioperative Complications
Time frame: Up to 6 months after surgery
Operative Time
Time frame: During surgery
Estimated Blood Loss
Time frame: During surgery
Length of Hospital Stay
Time frame: During the index hospitalization, up to 90 days after surgery
Overall Prostate Cancer Quality of Life Score Assessed Using the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)
Time frame: 1 year after surgery
Treatment-Free Survival
Time frame: 3 years after surgery
Systemic Treatment-Free Survival
Time frame: 3 years after surgery
Metastasis-Free Survival
Time frame: 3 years after surgery
Cost-Effectiveness
Time frame: 1 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No. No individual participant data sharing plan is currently available.
Related trials for Prostate Cancer
RecruitingObservational study
The BALANCE Study: BlAck and Mixed Men's Lived Experience With Prostate cANCEr-Diversity in Prostate Cancer PROMS Study
Prostate Cancer
RecruitingObservational study
Advanced Radiotherapy (ART) in Prostate Cancer (PROST-ART)
Prostate Cancer
RecruitingObservational study
The Investigation of New Biological Markers for Prostate Cancer Diagnosis and Management in Chinese Population
Prostate Cancer
Not yet recruitingPhase 2
Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance
Adenocarcinoma, Prostate Cancer
RecruitingObservational study
The PROFILE Study: Germline Genetic Profiling: Correlation With Targeted Prostate Cancer Screening and Treatment
Prostate Cancer, Prostate Biopsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giancarlo Marra, MD principal investigator
Principal Investigator
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral Extended Pelvic Lymph Node Dissection and Bilateral Extended Pelvic Lymph Node Dissection in people with Prostate Cancer, run by University of Turin, Italy at 14 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiara Fiameni (+39 011 633 6591, chiara.fiameni@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical Recurrence-Free Survival (time frame: 3 years after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.