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

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