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

5. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

820

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Unilateral Extended PLND
Extended pelvic lymph node dissection performed only on the side of the dominant prostate cancer lesion during robot-assisted radical prostatectomy.
Fremgangsmåte: 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.
Fremgangsmåte: Bilateral Extended Pelvic Lymph Node Dissection
Extended pelvic lymph node dissection performed bilaterally according to the study surgical template during robot-assisted radical prostatectomy.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Turin, Italy

Samarbeidspartnere

AIRC (Italian Association for Cancer Research)
Fondazione Ricerca Molinette

Etterforskere

  • Hovedetterforsker: Giancarlo Marra, MD, Principal Investigator

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. mars 2026

Primær fullføring (Antatt)

1. desember 2029

Studiet fullført (Antatt)

1. desember 2030

Datoer for studieregistrering

Først innsendt

20. april 2026

Først innsendt som oppfylte QC-kriteriene

5. mai 2026

Først lagt ut (Faktiske)

12. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BALANCE_UTORINO_2026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

No individual participant data sharing plan is currently available.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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