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

5 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

820

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Italia
      • Bologna, Italia, 40138
        • Aún no reclutando
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola-Malpighi & University of Bologna
        • Contacto:
        • Investigador principal:
          • Lorenzo Bianchi, MD
      • Florence, Italia, 50134
        • Aún no reclutando
        • Università degli Studi di Firenze / AOU Careggi
        • Contacto:
        • Investigador principal:
          • Francesco Sessa, MD
      • Foggia, Italia, 71122
        • Aún no reclutando
        • Università degli Studi di Foggia / AO Ospedali Riuniti di Foggia
        • Contacto:
        • Investigador principal:
          • Ugo Falagario, MD
      • Genova, Italia, 16132
        • Aún no reclutando
        • IRCCS Ospedale Policlinico San Martino & University of Genoa
        • Investigador principal:
          • Matteo Bauckneht, MD
        • Contacto:
          • Francesca Ambrosini, MD
          • Número de teléfono: +39 010 555 3473
          • Correo electrónico: f.ambrosini@gmail.com
      • Milan, Italia, 20162
        • Aún no reclutando
        • ASST Grande Ospedale Metropolitano Niguarda
        • Contacto:
        • Investigador principal:
          • Paolo Dell'Oglio, MD
      • Milan, Italia, 20141
        • Aún no reclutando
        • IEO, Istituto Europeo di Oncologia
        • Contacto:
        • Investigador principal:
          • Ettore Di Trapani, MD
      • Modena, Italia, 41124
        • Aún no reclutando
        • Università degli Studi di Modena / AOU Modena
        • Contacto:
        • Investigador principal:
          • Stefano Puliatti, MD
      • Naples, Italia, 80131
        • Aún no reclutando
        • Istituto Nazionale Tumori, IRCCS, Fondazione "G. Pascale"
        • Contacto:
        • Investigador principal:
          • Gianluca Spena, MD
      • Roma, Italia, 00133
        • Aún no reclutando
        • Università Tor Vergata / Policlinico Tor Vergata
        • Contacto:
        • Investigador principal:
          • Simone Albisinni, MD
      • Roma, Italia, 00144
        • Aún no reclutando
        • IFO - Istituti Fisioterapici Ospitalieri
        • Investigador principal:
          • Giuseppe Simone, MD
        • Contacto:
      • Roma, Italia, 00168
        • Aún no reclutando
        • Policlinico Universitario Gemelli IRCCS & Università Cattolica del Sacro Cuore
        • Contacto:
        • Investigador principal:
          • Bernardo Maria Cesare Rocco, MD
      • Torino, Italia, 10126
        • Reclutamiento
        • AOU Città della Salute e della Scienza di Torino, Ospedale Molinette
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Giancarlo Marra, MD
      • Verona, Italia, 37134
        • Aún no reclutando
        • Università degli Studi di Verona / AOU Verona
        • Contacto:
        • Investigador principal:
          • Riccardo Bertolo, MD
    • Milano
      • Rozzano, Milano, Italia, 20089
        • Aún no reclutando
        • Humanitas Clinical and Research Centre & Humanitas University
        • Contacto:
        • Investigador principal:
          • Giovanni Lughezzani, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Unilateral Extended PLND
Extended pelvic lymph node dissection performed only on the side of the dominant prostate cancer lesion during robot-assisted radical prostatectomy.
Procedimiento: 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.
Comparador activo: Bilateral Extended PLND
Extended pelvic lymph node dissection performed bilaterally during robot-assisted radical prostatectomy.
Procedimiento: Bilateral Extended Pelvic Lymph Node Dissection
Extended pelvic lymph node dissection performed bilaterally according to the study surgical template during robot-assisted radical prostatectomy.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Biochemical Recurrence-Free Survival
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Perioperative Complications
Periodo de tiempo: 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
Periodo de tiempo: During surgery
Total operative time recorded during robot-assisted radical prostatectomy and pelvic lymph node dissection.
During surgery
Estimated Blood Loss
Periodo de tiempo: During surgery
Intraoperative estimated blood loss.
During surgery
Length of Hospital Stay
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 3 years after surgery
Absence of any salvage local or systemic treatment after surgery.
3 years after surgery
Systemic Treatment-Free Survival
Periodo de tiempo: 3 years after surgery
Absence of systemic treatment after surgery.
3 years after surgery
Metastasis-Free Survival
Periodo de tiempo: 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
Periodo de tiempo: 1 year after surgery
Cost-effectiveness assessed as incremental cost per quality-adjusted life year at 1 year after surgery.
1 year after surgery

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Turin, Italy

Colaboradores

AIRC (Italian Association for Cancer Research)
Fondazione Ricerca Molinette

Investigadores

  • Investigador principal: Giancarlo Marra, MD, Principal Investigator

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

30 de marzo de 2026

Finalización primaria (Estimado)

1 de diciembre de 2029

Finalización del estudio (Estimado)

1 de diciembre de 2030

Fechas de registro del estudio

Enviado por primera vez

20 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de mayo de 2026

Publicado por primera vez (Actual)

12 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • BALANCE_UTORINO_2026

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

No individual participant data sharing plan is currently available.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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