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Background: Current surgical and ablative treatment options for prostate cancer (PCa) may result in a high incidence of (temporary) incontinence, erectile dysfunction and/or bowel damage. These side effects are due to procedure related effects on adjacent structures including blood vessels, bowel, urethra and/or neurovascular bundle. Ablation with irreversible electroporation (IRE) has shown to be effective and safe in destroying PCa cells and also has the potential advantage of sparing surrounding tissue and vital structures, resulting in less impaired functional outcomes and maintaining men's quality of life.Methods/design: In this randomized controlled trial (RCT) on IRE in localized PCa, 200 patients with organ-confined, unilateral (T1c-T2b) low- to intermediate-risk PCa (Gleason sum score 6 and 7) on transperineal template-mapping biopsies (TTMB) will be included. Patients will be randomized into focal or extended ablation of cancer foci with IRE. Oncological efficacy will be determined by multiparametric Magnetic Resonance Imaging, Contrast-Enhanced Ultrasound imaging if available, TTMP and Prostate Specific Antigen (PSA) follow-up. Patients will be evaluated up to 5 years on functional outcomes and quality of life with the use of standardized questionnaires.Discussion: There is critical need of larger, standardized RCTs evaluating long-term oncological and functional outcomes before introducing IRE and other focal therapy modalities as an accepted and safe therapeutic option for PCa. This RCT will provide important short- and long-term data and elucidates the differences between focal or extended ablation of localized, unilateral low- to intermediate-risk PCa with IRE.Trial Registration: Clinicaltrials.gov database registration number NCT01835977. The Dutch Central Committee on Research Involving Human Subjects registration number NL50791.018.14. [ABSTRACT FROM AUTHOR]

Contemporary minimally invasive surgical (MIS) treatment options of patients with male Lower Urinary Tract Symptoms (LUTS) in men with prostate glands >80 mL include Holmium Laser Enucleation Prostate (HoLEP), Thulium laser VapoEnucleation Prostate (ThuVEP), and Laparoscopic (LSP) or Robotic-Assisted Simple Prostatectomy (RASP). Implementing new laser technologies is costly, and the steep learning curve of these laser techniques limit their wide range use. This promoted the use of LSP and RASP in centers with readily established laparoscopy or robotic surgery programs. The aim of this study is to review case and comparative series of RASP. We systematically reviewed published data from 2008 to 2020 on RASP and have identified 26 non-comparative and 9 comparative case series. RASP has longer operation time but less time spent in hospital and less blood loss. The outcomes of improvements in symptom score, post-voiding residual urine (PVR), postoperative PSA decline, complications, and cost are similar when compared to open and laser enucleation techniques. These outcomes position RASP as a viable MIS treatment option for patients with male LUTS needing surgical treatment for enlarged prostates. Nevertheless, prospective, randomized controlled trials (RCTs) with multicenter and large sample size are needed to confirm the findings of this systematic review. [ABSTRACT FROM AUTHOR]