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.
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.