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

ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Turin, Italy

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Unilateral Extended Pelvic Lymph Node Dissection

    Procedure/Surgery

    Extended pelvic lymph node dissection performed only on the side of the dominant lesion, as defined by biopsy, multiparametric MRI, and PSMA PET findings.

  • Bilateral Extended Pelvic Lymph Node Dissection

    Procedure/Surgery

    Extended pelvic lymph node dissection performed bilaterally according to the study surgical template during robot-assisted radical prostatectomy.

Treatment groups

820 Participants
are divided into 2 treatment groups
Group A: Unilateral Extended PLNDExperimental treatment 1 intervention
Group B: Bilateral Extended PLNDActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Biochemical Recurrence-Free Survival

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

Time frame
3 years after surgery
2

PSA Persistence

Postoperative PSA greater than 0.1 ng/mL at 6 weeks after surgery confirmed by an additional PSA measurement performed 2 weeks later.

Time frame
8 weeks after surgery

Secondary outcomes

1

Perioperative Complications

Complications graded using the Clavien-Dindo classification and assessed for likelihood of being related to pelvic lymph node dissection.

Time frame
Up to 6 months after surgery
2

Operative Time

Total operative time recorded during robot-assisted radical prostatectomy and pelvic lymph node dissection.

Time frame
During surgery
3

Estimated Blood Loss

Intraoperative estimated blood loss.

Time frame
During surgery
4

Length of Hospital Stay

Number of days from surgery to discharge from the index hospitalization.

Time frame
During the index hospitalization, up to 90 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Turin, Italy

Lead sponsor

AIRC (Italian Association for Cancer Research)

Collaborator

Fondazione Ricerca Molinette

Collaborator

Source ClinicalTrials.gov
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