Interventional procedure overview of irreversible electroporation for treating prostate cancer

Efficacy summary

Survival and recurrence

In a systematic review of 7,383 patients with prostate cancer, cancer-specific survival for IRE was 98% (95% CI 94% to 102%; 2 studies, n=48, median follow up 6 to 7 months; I²=0%, p=0.966), overall survival was 99% (95% CI 98% to 101%; 3 studies, n=171, median follow up 6 to 36 months; I²=0%, p=0.736), failure-free survival was 90% (95% CI 83% to 98%; 3 studies, n=575, median follow up 6 to 72 months; I²=87.8%, p=0.000) and metastasis-free survival was 99% (95% CI 98% to 101%; 2 studies, n=146, median follow up 6 to 36 months; I²=0%, p=0.665; Guo 2021).

In a case series of 429 patients with prostate cancer and 471 IRE treatments, there were recurrences in 10% (47/471) of treatments; 3 were in patients with Gleason scores of 6, 18 were in patients with Gleason scores of 7, and 26 were in patients with Gleason scores of greater than 7 (with higher scores indicating greater severity). Of these recurrences, 27 were in or adjacent to the IRE field (1 in a patient with Gleason 6 score, 10 in patients with Gleason 7 scores, and 16 in patients with Gleason scores greater than 7). Estimated recurrence-free survival at 5 years according to Kaplan–Meier analysis was 95% for low grade cancer (Gleason score 6), 85% for intermediate grade cancer (Gleason score 7) and 61% for high grade cancer (Gleason score >7; Guenther 2019).

In a case series of 123 patients, failure-free survival at 3 years after IRE was estimated at 97% in Kaplan–Meier analysis. Metastasis-free survival was 99% (68/69) at 3‑year follow up and overall survival was 100% (69/69) at 3‑year follow up (Blazevski 2020).

In a case series of 50 patients, failure-free survival in patients with greater than 3‑year follow up was 90% (36/40; Blazevski 2021).

Biopsy outcomes

In the systematic review of 7,383 patients with prostate cancer, the pooled proportion of positive biopsy after procedure in patients with IRE was 24% (95% CI 18% to 31%; 5 studies, n=193; I²=0%, p=0.734) with median follow up across studies ranging from 7 to 20 months (Guo 2021).

In the case series of 123 patients, 78% (79/102) of patients having biopsy were free of clinically significant cancer, 10% (10/102) had significant in-field disease and 13% (13/102) had significant in-field disease at 12‑month follow up (Blazevski 2020).

In a non-randomised cohort study of 100 patients, 29.5% (13/44) of the people having biopsy had residual PCa at 12 months, and 1 patient was diagnosed with metastatic disease directly after IRE because of persisting elevated PSA (>10 nanograms/ml; Scheltema 2018a).

In a case series of 63 patients, 78% (79/102) of people having biopsy were free of clinically significant cancer, 16% (7/45) had significant in-field disease and 10% (4/41) had significant out-of-field disease at 6 to 12‑month follow up (van den Bos 2018).

MRI outcomes

In the case series of 123 patients, 80% (90/102) of patients who had MRI had clear scans, 3% (3/112) had in-field lesions, 5% (6/112) had adjacent-to-field lesions, 10% (11/112) had out-of-field lesions and 5% (6/112) had both in and out-of-field lesions at 6-month follow up (Blazevski 2020).

In the case series of 63 patients, 86% (47/55) of patients who had an MRI were free of lesions, 7% (4/55) had in-field lesions, 4% (2/55) had out-of-field lesions and 4% (2/55) had both in-field and out-of-field lesions at 6-month follow up (van den Bos 2018).

In the case series of 50 patients, 86% (43/50) of patients who had an MRI were free of lesions, and 14% (7/50) had in-field lesions (Blazevski 2021).

Reduction in PSA

In the case series of 123 patients, there was a reduction in median PSA levels of 57% to 2.5 nanograms/ml (IQR 1.43 to 5.675 nanograms/ml) at 12-month follow up from an initial baseline value of 5.7 nanograms/ml (Blazevski 2020).

In the non-randomised comparative study of 100 patients, there was a reduction in median PSA of 51% (IQR 28 to 85%) to 2.8 nanograms/ml at 12‑month follow up in patients who had IRE from a baseline value of 5.9 nanograms/ml (IQR 3.3 to 7.3; Scheltema 2018a).

In a case series of 63 patients, there was a reduction in median PSA of 70% to 1.8 nanograms/ml (IQR 0.96 to 4.8 nanogram/ml) at 6 to 12-month follow up from an initial baseline value of 6 nanograms/ml (IQR 3.2 to 8.4; Scheltema 2018b).

In the case series of 50 patients, there was a reduction in median PSA of 71% to 1.7 nanograms/ml (IQR 0.84 to 3.35) from a baseline value of 6.25 nanograms/ml (IQR 4.35 to 8.9; Blazevski 2021).