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

NCT07580196 | Recruiting

• 1 other identifier: BALANCE_UTORINO_2026
• Study Type: interventional
• Target: 820
• Locations: 1 country
• Sites: 14

Brief 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. 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

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

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  8 weeks after surgery

Secondary Outcomes (9)

• Perioperative Complications

  Up to 6 months after surgery

• Operative Time

  During surgery

• Estimated Blood Loss

  During surgery

• Length of Hospital Stay

  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)

  1 year after surgery

Study Arms (2)

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.

Procedure: Unilateral Extended Pelvic Lymph Node Dissection

Bilateral Extended PLND

ACTIVE COMPARATOR

Extended pelvic lymph node dissection performed bilaterally during robot-assisted radical prostatectomy.

Procedure: Bilateral Extended Pelvic Lymph Node Dissection

Interventions

Unilateral Extended Pelvic Lymph Node Dissection PROCEDURE

Extended pelvic lymph node dissection performed only on the side of the dominant lesion, as defined by biopsy, multiparametric MRI, and PSMA PET findings.

Unilateral Extended PLND

Bilateral Extended Pelvic Lymph Node Dissection PROCEDURE

Extended pelvic lymph node dissection performed bilaterally according to the study surgical template during robot-assisted radical prostatectomy.

Bilateral Extended PLND

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Turin, Italy: lead
• AIRC (Italian Association for Cancer Research): collaborator
• Fondazione Ricerca Molinette: collaborator

Study Sites (14)

Humanitas Clinical and Research Centre & Humanitas University

Rozzano, Milano, 20089, Italy

NOT YET RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola-Malpighi & University of Bologna

Bologna, 40138, Italy

NOT YET RECRUITING

Università degli Studi di Firenze / AOU Careggi

Florence, 50134, Italy

NOT YET RECRUITING

Università degli Studi di Foggia / AO Ospedali Riuniti di Foggia

Foggia, 71122, Italy

NOT YET RECRUITING

IRCCS Ospedale Policlinico San Martino & University of Genoa

Genova, 16132, Italy

NOT YET RECRUITING

IEO, Istituto Europeo di Oncologia

Milan, 20141, Italy

NOT YET RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

NOT YET RECRUITING

Università degli Studi di Modena / AOU Modena

Modena, 41124, Italy

NOT YET RECRUITING

Istituto Nazionale Tumori, IRCCS, Fondazione "G. Pascale"

Naples, 80131, Italy

NOT YET RECRUITING

Università Tor Vergata / Policlinico Tor Vergata

Roma, 00133, Italy

NOT YET RECRUITING

IFO - Istituti Fisioterapici Ospitalieri

Roma, 00144, Italy

NOT YET RECRUITING

Policlinico Universitario Gemelli IRCCS & Università Cattolica del Sacro Cuore

Roma, 00168, Italy

NOT YET RECRUITING

AOU Città della Salute e della Scienza di Torino, Ospedale Molinette

Torino, 10126, Italy

RECRUITING

Università degli Studi di Verona / AOU Verona

Verona, 37134, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Giancarlo Marra, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara Fiameni

CONTACT

+39 011 633 6591; chiara.fiameni@unito.it

Alessandro Marquis, MD

CONTACT

+39 011 633 6591; alessandro.marquis@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 12, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (14)