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

5. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

820

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Unilateral Extended PLND
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
Extended pelvic lymph node dissection performed only on the side of the dominant lesion, as defined by biopsy, multiparametric MRI, and PSMA PET findings.
Aktiv komparator: Bilateral Extended PLND
Extended pelvic lymph node dissection performed bilaterally during robot-assisted radical prostatectomy.
Procedure: Bilateral Extended Pelvic Lymph Node Dissection
Extended pelvic lymph node dissection performed bilaterally according to the study surgical template during robot-assisted radical prostatectomy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Biochemical Recurrence-Free Survival
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Turin, Italy

Samarbejdspartnere

AIRC (Italian Association for Cancer Research)
Fondazione Ricerca Molinette

Efterforskere

  • Ledende efterforsker: Giancarlo Marra, MD, Principal Investigator

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. marts 2026

Primær færdiggørelse (Anslået)

1. december 2029

Studieafslutning (Anslået)

1. december 2030

Datoer for studieregistrering

Først indsendt

20. april 2026

Først indsendt, der opfyldte QC-kriterier

5. maj 2026

Først opslået (Faktiske)

12. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BALANCE_UTORINO_2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

No individual participant data sharing plan is currently available.

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