Real-World Comparative Safety and Effectiveness of Irreversible Electroporation and High-Intensity Focused Ultrasound for Prostate Cancer Ablation.

OBJECTIVES

To assess the comparative safety and effectiveness of 2 prostate cancer treatment ablation modalities: irreversible electroporation (IRE) and high-intensity focused ultrasound (HIFU).  METHODS: Two systematic literature reviews (SLRs) and meta-analyses (MAs) on IRE and HIFU were conducted in accordance with PRISMA guidelines. Searches were conducted in PubMed and EMBASE. Independent reviewers assessed literature eligibility and abstracted safety and effectiveness data. Oncological, safety, functional, and quality of life (QOL) outcomes were examined for each technology. MAs were conducted where data quality and availability allowed, using normal methods and a random/mixed effects model, and quality assessments performed.

RESULTS

Fifty-five publications (n = 22 IRE; n = 33 HIFU) were included in the SLRs, and MAs were conducted on negative in-field post-procedure biopsy, prostate-specific antigen (PSA) level reduction, potency, urinary continence, and AE rate outcomes. MAs revealed that IRE patients had lower mean percent PSA level reductions, higher mean rates of in-field negative post-treatment biopsy, and higher rates of potency maintenance than HIFU patients. Most adverse events (AEs) reported were comparable and minor (Grades I, II), with urinary tract infection, dysuria, hematuria, and incontinence or urgency most frequently reported. The proportion of patients experiencing a severe AE (≥Grade III) ranged from 0 to 8% after IRE and HIFU. Both modalities were associated with positive functional outcomes as well as maintenance of QOL after treatment.

CONCLUSIONS

Both IRE and HIFU were found to produce favorable effectiveness outcomes and have low complication rates while minimally impacting patient urinary and erectile function and maintaining overall QOL. These real-world findings can help guide clinical decision making and improve disease management for patients with prostate cancer.