JU INSIGHT: Focal Therapy of Prostate Cancer Index Lesion With Irreversible Electroporation: A Prospective Phase II Study With a Median Follow-up of 3 Years

By: Bernardino Miñana López, MD, PhD; Guillermo Andrés Boville, MD, PhD; Guillermo Barbas Bernardos, MD, PhD; Xabier Ancizu Marckert, MD; Marcos Torres Roca, MD; Luis Labairu Huerta, MD, PhD; Felipe Villacampa Aubá, MD; Fernando Ramón de Fata Chillón, MD, PhD; Julian Sanz Ortega, MD, PhD; Marta Abengózar Muela, MD; Guillermo Gallardo Madueño, MD; Alberto Benito Boíllos, MD, PhD; Andrés Alcázar Peral, MD; Fernando Díez-Caballero Alonso, MD, PhD | Posted on: 17 Jan 2023

Miñana López B, Andrés Boville G, Barbas Bernardos G, et al. Focal therapy of prostate cancer index lesion with irreversible electroporation: a prospective phase II study with a median follow-up of 3 years. J Urol. 2023;209(1): 261-270.

Study Need and Importance

Focal therapy (FT) for prostate cancer (Pca) is a therapeutic approach aiming for tumor control while minimizing the side effects that can be associated with radical treatments. Irreversible electroporation (IRE) is a nonthermal tissue ablation technology based on the emission of short electrical pulses that allows treatment on any part of the prostate with a security margin.

The widespread use of multiparametric MRI (mpMRI) and the development of ultrasound-MRI fusion systems for targeting biopsies allow the implementation of FT programs. However, long-term results on its ability to achieve cancer control and preserve functional outcomes, especially using IRE, are still lacking.

Table. Unfavorable Urodynamic Parameters

Parameter Within the first year of SCI 1-Mo
Urodynamics performed, No. (%) 97 (100) 90 (93) 85 (88) 75 (77) 73 (75)
DO and DSD, No. (%) 85 (88) 61 (68) 63 (74) 55 (73) 52 (71)
Maximum storage detrusor pressure
 ≥40 cm H2O, No. (%) 38 (39) 21 (23) 18 (21) 24 (32) 11 (15)
 Filling volume when pDet = 40 mL, median (Q1-Q3) 505 (215-610) 525 (278-753) 398 (258-663) 300 (195-500)
Bladder compliance <20 mL/cm H2O, No. (%) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
Videourodynamics performed, No. (%) 96 (99) 88 (98) 76 (89) 67 (89) 68 (93)
Vesicoureteral reflux, No. (%)a 7 (7) 4 (5) 5 (7) 2 (3) 2 (3)
At least 1 unfavorable parameter, No. (%) 87 (90) 65 (72) 67 (79) 61 (81) 55 (75)
Abbreviations: DO, detrusor overactivity; DSD, detrusor sphincter dyssynergia; pDET, detrusor pressure; Q, quartile; SCI, spinal cord injury.
aVesicoureteral reflux grade: 1 month, 4 grade I; 3 months, 1 grade I, 3 grade II, 1 grade III; 6 months, 1 grade II, 1 grade III; 12 months: 2 grade I.

To our knowledge this is the first prospective study published with all patients selected based on a combination of mpMRI and a transperineal systematic and targeted systematic transperineal biopsy using an MRI-ultrasound fusion system (Koelis System) without loss of patients to follow-up.

Patients were selected if they had a biopsy-proven low- to intermediate-risk Pca concordant with lesions visible on mpMRI. All procedures were performed by the same surgeon.

Figure. Kaplan-Meier curves showing in-field and out-of-field recurrence-free survival.

What We Found

FT using IRE is a reliable, safe, and effective procedure for treating Pca with 85% probability of achieving tumor control in the treated volume at 3 years. There seems to be a risk of recurrence over time in untreated areas (see Figure).

Continence was preserved in all patients and potency in 94% of those previously potent.


Limitations included: single center; small sample (41 patients); 80% underwent control biopsy and most patients had low risk-Pca (International Society of Urological Pathology grade 1-2).

Interpretation for Patient Care

FT using IRE is a minimally invasive therapeutic option for patients with visible lesions on mpMRI with minimal side effects. At least, it could delay radical treatments in patients on active surveillance. A close follow-up is needed.