Prospective Study on the Role of Radical Prostatectomy in Oligo-metastatic Hormone-sensitive Prostate Cancer in Patients on Androgen Deprivation Therapy

MAZINGA is a prospective, single-group pilot study evaluating disease control after robot-assisted radical prostatectomy with extended pelvic lymph-node dissection in men with oligometastatic hormone-sensitive prostate adenocarcinoma who have received androgen-deprivation therapy for at least 6 months and achieved a serum prostate-specific antigen (PSA) level below 4 ng/mL. Eligible participants have no more than five bone metastases confined to the spine and/or pelvis, no visceral or retroperitoneal lymph-node metastases, and no bulky pelvic lymph nodes.

All participants undergo surgery and continue androgen-deprivation therapy as prescribed by their treating oncologist. PSA and serum testosterone are assessed for 24 months. Contrast-enhanced computed tomography plus whole-body bone scintigraphy, or prostate-specific membrane antigen positron emission tomography according to the imaging approach used at staging and clinical judgment, is performed every 6 months. The study evaluates overall survival, progression-free survival, pathological and PSA responses, quality of life, serum biomarkers, urinary complications, and conversion to open surgery.