Unilateral versus bilateral extended pelvic lymph node dissection for men with unilateral high‑risk prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

BALANCE is a multicenter, prospective, randomized controlled trial in Italy comparing unilateral versus bilateral extended pelvic lymph node dissection in men with unilateral high-risk localized prostate cancer. Eligible patients are identified by prostate biopsy, multiparametric MRI, and PSMA PET and are randomized 1:1 at the time of planned robot-assisted radical prostatectomy. The co-primary endpoints are 3-year biochemical recurrence-free survival and early postoperative PSA persistence, with secondary endpoints addressing postoperative morbidity and staging outcomes. Modern PSMA PET and mpMRI are used to select patients with predominantly unilateral disease to test whether a selective surgical approach reduces harms without compromising oncologic control.

Why it matters

Who can join: the full rules

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

Where it's running

• AOU Città della Salute e della Scienza di Torino, Ospedale Molinette
  Torino, Italy Recruiting
• Humanitas Clinical and Research Centre & Humanitas University
  Rozzano, Milano, Italy Not yet recruiting
• IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola-Malpighi & University of Bologna
  Bologna, Italy Not yet recruiting
• Università degli Studi di Firenze / AOU Careggi
  Florence, Italy Not yet recruiting
• Università degli Studi di Foggia / AO Ospedali Riuniti di Foggia
  Foggia, Italy Not yet recruiting
• IRCCS Ospedale Policlinico San Martino & University of Genoa
  Genova, Italy Not yet recruiting

Study contacts

• Principal investigator: Giancarlo Marra, MD — Principal Investigator
• Study coordinator: Chiara Fiameni
• Email: chiara.fiameni@unito.it
• Phone: +39 011 633 6591

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.