Interventional procedure overview of irreversible electroporation for treating prostate cancer

Safety summary

Recto-prostatic fistula

In the case series of 429 patients and 471 IRE treatments, recto-prostatic fistula was reported in 1 patient (Guenther 2019).

Bladder perforation

In the case series of 429 patients and 471 IRE treatments, bladder perforation by catheter recto-prostatic fistula was reported in 1 patient (Guenther 2019).

Severe prostatitis

In the case series of 429 patients and 471 IRE treatments, severe prostatitis was reported in 1 patient (Guenther 2019).

Permanent urinary retention

In the case series of 429 patients and 471 IRE treatments, permanent urinary retention was reported in less than 1% (4/471) of treatments (Guenther 2019).

Urinary incontinence

In the non-randomised comparative study of 100 patients, pad-free continence rates were 98%, 87%, 96%, 98% and 96% at baseline, 6 weeks, 3 months, 6 months, and 12 months respectively; these values increased to 100%, 89%, 98%, 100% and 100% respectively in those continent at baseline (Scheltema 2018a).

In the case series of 429 patients and 471 IRE treatments, 8% (12/155) of the evaluated patient IPSS (scored 0 to 35, whereby a higher score indicates more severe urinary symptoms) increased temporarily from below 8 to above 19 (severe symptoms) after IRE. In patients fully continent before IRE, no urinary incontinence was seen 12 months after IRE (Guenther 2019).

Erectile dysfunction

In the case series of 429 patients and 471 IRE treatments, there was a mean points change in IIEF-5 score (measured 5 to 25, whereby 5 indicates severe ED and 25 indicates no ED) of -8.7 points up to 18-months follow up, and a change of -3.9 points after 18-month follow up (p=0.045).

In the same study, 45% (56/124) of patients reported reduction of ED, 11% (14/124) experienced transient severe ED (which resolved in 12 months), and 3% (4/124) experienced ED that persisted for longer than 12 months (Guenther 2019).

In the non-randomised comparative study of 100 patients, ESI rates were 69%, 40%, 54%, 49% and 56% at baseline, 6 weeks, 3 months, 6 months and 12 months respectively; these values increased to 100%, 57%, 74%, 65% and 72% respectively in those potent at baseline (Scheltema 2018a).

In a case series of 63 patients, the median EPIC sexual function summary scores (scored 1 to 100, with 100 indicating greater sexual function) were 66 (IQR 47 to 85), 50 (IQR 27 to 75), 54 (IQR 29 to 72) and 48 (IQR 15 to 77) at baseline, 3 months, 6 months, and 12 months respectively (p<0.001 for significance between baseline and 6 months; van den Bos 2018).

In the same study, ESI rates were 70% (31/44), 55% (24/44), 46% (20/43) and 53% (10/19) at baseline, 3 months, 6 months and 12 months respectively. Impotence was present in 31% (8/26) of surveyed patients at 6 months, and 23% (3/13) at 12 months (van den Bos 2018).

In the case series of 60 patients, EPIC sexual domain scores were 60 (IQR 25 to 82), 52 (IQR 29 to 71), 46 (IQR 14 to 79) and 27 (IQR 2 to 79) for anterior segments at baseline, 3 months, 6 months and 12 months respectively, with a statistically significant difference between baseline and 6 months (p=0.03; Scheltema 2018b).

In the case series of 50 patients, EPIC sexual scores were 65, 46, 51,57, 59 and 76 at baseline, 6 weeks, 3 months, 6 months,12 months and 24 months respectively, with a statistically significant difference between baseline and 12 months after IRE (p=0.001; Blazevski 2021).

Other adverse events

Moderate

In the case series of 429 patients and 471 IRE treatments, 1 patient reported prostatitis, 1 patient reported proctitis, less than 1% (3/471) reported epididymitis, 1 patient reported pseudo post-vasectomy syndrome, and UTI was reported in 3% (12/471) of treatments (Guenther 2019).

In the case series of 123 patients, 9% (11/123) of patients reported Clavien-Dindo grade 2 complications, which included UTI, incontinence, and acute urinary retention (Blazevski 2020).

In the non-randomised comparative study of 100 patients,14% (7/50) reported Clavien-Dindo grade 2 complications, which included UTI and severe postoperative pain related to the indwelling catheter (Scheltema 2018a).

In the case series of 63 patients, 11% (7/63) reported CTCAE grade 2 complications, which included UTIs, more severe urgency or frequency complaints, epididymitis, incontinence in 1 patient at 6 months (which resolved within 12 months), and prolonged catheterisation because of urinary retention in 1 patient (van den Bos 2020).

In the case series of 50 patients, 18% (9/50) of patients reported Clavien-Dindo grade 2 complications, which included UTI, severe urgency or frequency, and incontinence (Blazevski 2020).

Mild

In the case series of 429 patients and 471 IRE treatments, mild haematuria was reported in 4% (18/471) of treatments, transient urinary retention was reported in 9% (43/471) of treatments and dysuria was reported in 7% (32/471) of treatments (Guenther 2019).

In the case series of 123 patients, 22% (27/123) of patients reported Clavien-Dindo grade 1 complications, which included perineal pain, haematuria, dysuria, and urgency or frequency (Blazevski 2020).

In the non-randomised comparative study of 100 patients, 22% (11/50) of patients reported Clavien-Dindo grade 1 complications, which included mild haematuria, urgency, and postoperative pain (Scheltema 2018a).

In a case series of 63 patients, 24% of patients reported CTCAE grade 1 complications, which included haematuria, dysuria, urgency or frequency complaints and perineal pain (van den Bos 2018).

In the case series of 50 patients, 20% (10/50) of patients reported Clavien-Dindo grade 1 complications, which included dysuria, haematuria, urgency, and postoperative pain (Blazevski 2020).