Focal Therapy of Prostate Cancer Index Lesion with Irreversible Electroporation. A Prospective Study with a Median Follow-Up of Three Years
Bernardino Miñana López 1 , Guillermo Andrés Boville 1 , Guillermo Barbas Bernardos 1 , Xabier Ancizu Marckert 1 , Marcos Torres Roca 1 , Luis Labairu Huerta 1 , Felipe Villacampa Aubá 1 , Fernando Ramón de Fata Chillón 1 , Julian Sanz Ortega 2 , Marta Abengózar Muela 2 , Guillermo Gallardo Madueño 3 , Alberto Benito Boíllos 3 , Andrés Alcázar Peral 3 , Fernando Díez-Caballero Alonso 1
Purpose: To assess oncological, safety and quality of life (QoL) related outcomes of Focal Therapy with irreversible electroporation (IRE) in men with localized prostate cancer (Pca).
Material and methods: A single-center, phase II study.
Inclusion criteria: Pca ISUP grade 1-2, PSA<=15 ng/ml, <=cT2b. Patients were selected based on mpMRI and transperineal systematic and targeted MRI-Ultrasound fusion-guided biopsy. Ablation of index lesions with safety margin was performed. Primary endpoint was cancer control defined as the absence of any biopsy-proven tumor. A control transperineal biopsy was planned at 12 months and when suspected based on PSA and/or mpMRI information. QoL was assessed using EPIC urinary continence domain, IIEF5 and IPSS.
Results: From November 2014 to July 2021, 41 consecutive patients were included with a median follow-up of 36 months. Thirty patients (73%) had ISUP grade 1 tumors, 10 (24%) grade 2 and one (2,4%) grade 3. Recurrence was observed in 16 of 41 (39%) of the whole cohort, and 16 of 33 (48,4%) who underwent biopsy. In-field recurrence was detected in 5 (15%) and out-of-field in 11 (33,3%). 10 of 41 (24,6%) including 3 of 5 (60%) with in-field recurrences had significant tumors (Gleason pattern 4-5; more than one core or any>5 mm involved). Median recurrence-free survival was 32 mo (IC95% 6,7-57,2). Twenty-six patients (63,4%) were free from salvage treatment. All patients preserved urinary continence. Potency was maintained in 91,8%.
Conclusions: IRE can achieve satisfactory three years in-field tumor control with excellent QoL results in selected patients.