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

5 mai 2026 mis à jour par: Giancarlo Marra, University of Turin, Italy

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.

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

820

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Italie
      • Bologna, Italie, 40138
        • Pas encore de recrutement
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola-Malpighi & University of Bologna
        • Contact:
        • Chercheur principal:
          • Lorenzo Bianchi, MD
      • Florence, Italie, 50134
        • Pas encore de recrutement
        • Università degli Studi di Firenze / AOU Careggi
        • Contact:
        • Chercheur principal:
          • Francesco Sessa, MD
      • Foggia, Italie, 71122
        • Pas encore de recrutement
        • Università degli Studi di Foggia / AO Ospedali Riuniti di Foggia
        • Contact:
        • Chercheur principal:
          • Ugo Falagario, MD
      • Genova, Italie, 16132
        • Pas encore de recrutement
        • IRCCS Ospedale Policlinico San Martino & University of Genoa
        • Chercheur principal:
          • Matteo Bauckneht, MD
        • Contact:
      • Milan, Italie, 20162
        • Pas encore de recrutement
        • ASST Grande Ospedale Metropolitano Niguarda
        • Contact:
        • Chercheur principal:
          • Paolo Dell'Oglio, MD
      • Milan, Italie, 20141
        • Pas encore de recrutement
        • IEO, Istituto Europeo di Oncologia
        • Contact:
        • Chercheur principal:
          • Ettore Di Trapani, MD
      • Modena, Italie, 41124
        • Pas encore de recrutement
        • Università degli Studi di Modena / AOU Modena
        • Contact:
        • Chercheur principal:
          • Stefano Puliatti, MD
      • Naples, Italie, 80131
        • Pas encore de recrutement
        • Istituto Nazionale Tumori, IRCCS, Fondazione "G. Pascale"
        • Contact:
        • Chercheur principal:
          • Gianluca Spena, MD
      • Roma, Italie, 00133
        • Pas encore de recrutement
        • Università Tor Vergata / Policlinico Tor Vergata
        • Contact:
        • Chercheur principal:
          • Simone Albisinni, MD
      • Roma, Italie, 00144
        • Pas encore de recrutement
        • IFO - Istituti Fisioterapici Ospitalieri
        • Chercheur principal:
          • Giuseppe Simone, MD
        • Contact:
      • Roma, Italie, 00168
        • Pas encore de recrutement
        • Policlinico Universitario Gemelli IRCCS & Università Cattolica del Sacro Cuore
        • Contact:
        • Chercheur principal:
          • Bernardo Maria Cesare Rocco, MD
      • Torino, Italie, 10126
        • Recrutement
        • AOU Città della Salute e della Scienza di Torino, Ospedale Molinette
        • Contact:
        • Contact:
        • Chercheur principal:
          • Giancarlo Marra, MD
      • Verona, Italie, 37134
        • Pas encore de recrutement
        • Università degli Studi di Verona / AOU Verona
        • Contact:
        • Chercheur principal:
          • Riccardo Bertolo, MD
    • Milano
      • Rozzano, Milano, Italie, 20089
        • Pas encore de recrutement
        • Humanitas Clinical and Research Centre & Humanitas University
        • Contact:
        • Chercheur principal:
          • Giovanni Lughezzani, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Unilateral Extended PLND
Extended pelvic lymph node dissection performed only on the side of the dominant prostate cancer lesion during robot-assisted radical prostatectomy.
Procédure: Unilateral Extended Pelvic Lymph Node Dissection
Extended pelvic lymph node dissection performed only on the side of the dominant lesion, as defined by biopsy, multiparametric MRI, and PSMA PET findings.
Comparateur actif: Bilateral Extended PLND
Extended pelvic lymph node dissection performed bilaterally during robot-assisted radical prostatectomy.
Procédure: Bilateral Extended Pelvic Lymph Node Dissection
Extended pelvic lymph node dissection performed bilaterally according to the study surgical template during robot-assisted radical prostatectomy.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Biochemical Recurrence-Free Survival
Délai: 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
3 years after surgery
PSA Persistence
Délai: 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.
8 weeks after surgery

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Perioperative Complications
Délai: Up to 6 months after surgery
Complications graded using the Clavien-Dindo classification and assessed for likelihood of being related to pelvic lymph node dissection.
Up to 6 months after surgery
Operative Time
Délai: During surgery
Total operative time recorded during robot-assisted radical prostatectomy and pelvic lymph node dissection.
During surgery
Estimated Blood Loss
Délai: During surgery
Intraoperative estimated blood loss.
During surgery
Length of Hospital Stay
Délai: During the index hospitalization, up to 90 days after surgery
Number of days from surgery to discharge from the index hospitalization.
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)
Délai: 1 year after surgery
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.
1 year after surgery
Treatment-Free Survival
Délai: 3 years after surgery
Absence of any salvage local or systemic treatment after surgery.
3 years after surgery
Systemic Treatment-Free Survival
Délai: 3 years after surgery
Absence of systemic treatment after surgery.
3 years after surgery
Metastasis-Free Survival
Délai: 3 years after surgery
Absence of metastatic disease during follow-up, including PSMA PET assessment when clinically indicated after multidisciplinary discussion.
3 years after surgery
Cost-Effectiveness
Délai: 1 year after surgery
Cost-effectiveness assessed as incremental cost per quality-adjusted life year at 1 year after surgery.
1 year after surgery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Turin, Italy

Collaborateurs

AIRC (Italian Association for Cancer Research)
Fondazione Ricerca Molinette

Les enquêteurs

  • Chercheur principal: Giancarlo Marra, MD, Principal Investigator

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

30 mars 2026

Achèvement primaire (Estimé)

1 décembre 2029

Achèvement de l'étude (Estimé)

1 décembre 2030

Dates d'inscription aux études

Première soumission

20 avril 2026

Première soumission répondant aux critères de contrôle qualité

5 mai 2026

Première publication (Réel)

12 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BALANCE_UTORINO_2026

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

No individual participant data sharing plan is currently available.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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