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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 follow-up |
3-Mo follow-up |
6-Mo follow-up |
12-Mo follow-up |
|---|---|---|---|---|---|
| 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. |
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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
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.
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