NanoKnife Prostate Ablation: Safety and Effectiveness
Irreversible Electroporation Shows Promise for Intermediate-Risk Prostate Cancer in PRESERVE Trial
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Novel Ablation Technique Demonstrates Favorable Oncological adn Safety Outcomes
New York, NY – July 22, 2025 – A groundbreaking study, the prospective, single-arm PRESERVE trial, has revealed promising short-term oncological outcomes for irreversible electroporation (IRE) as a treatment for select patients with intermediate-risk prostate cancer. The findings,published in european urology,suggest that IRE could be a viable therapeutic option for this patient population.
Understanding Irreversible Electroporation (IRE)
IRE, also known as NanoKnife, is a minimally invasive ablation technique that uses high-voltage electrical pulses to create permanent pores in cell membranes, leading to cell death.Unlike thermal ablation methods, IRE is thought to spare critical structures like nerves and blood vessels, potentially preserving function. In the PRESERVE trial, patients received IRE of the prostate using high voltage (2-3 kV) pulses lasting up to 100 microseconds, delivered thru two to six monopolar probes.
PRESERVE Trial: Design and Patient Population
The PRESERVE trial enrolled 121 adult patients diagnosed with intermediate-risk prostate cancer across 17 clinical trial sites in the United States. To be eligible, participants had to meet specific criteria:
Be at least 50 years of age.
Have histologically confirmed organ-confined prostate cancer staged ≤T2c.
Possess at least a 10-year life expectancy.
Have a Gleason score of 3+4 or 4+3.
exhibit a PSA level of 15 ng/mL or lower, or a PSA density lower than 0.2 ng/mL if PSA was greater than 15 ng/mL.
Show no evidence of extraprostatic extension or seminal vesicle invasion on mpMRI.
The trial’s primary efficacy endpoint was the rate of negative in-field biopsy at 12 months, while the primary safety endpoint focused on the incidence of adverse events (AEs) through the same period. Secondary outcomes included PSA kinetics, changes in prostate volume, retreatment rates, and urinary and sexual function.
Efficacy and Functional Outcomes
The study reported encouraging results regarding the preservation of sexual function.At 12 months post-treatment, a critically important 84% of patients who had good baseline sexual function maintained erections sufficient for penetration. This finding is particularly noteworthy as maintaining sexual health is a crucial consideration for patients undergoing prostate cancer treatment.
Safety Profile of IRE
Regarding safety, the PRESERVE trial indicated that 86% of patients experienced at least one adverse event, with the majority being mild to moderate (grade 1 to 2). The most frequently reported AEs included:
Hematuria (44%)
erectile dysfunction (18%)
Dysuria (16%)
Urinary retention (15%)
Micturition urgency (14%)
Pollakiuria (12%)
Hematospermia (12%)
More severe adverse events (grade 3 or higher) were reported in 12% of patients (n = 14).Of these, three patients experienced procedure-related grade 3 AEs. These safety data suggest that while AEs are common,they are predominantly manageable.
Conclusion: A Promising Future for IRE
The authors of the PRESERVE trial concluded that the promising short-term oncological outcomes provide supporting evidence for IRE as a viable treatment for select cases of localized prostate cancer. This research marks a significant step forward in exploring innovative therapeutic approaches for intermediate-risk prostate cancer, offering hope for improved outcomes and quality of life for patients.REFERENCES
- George AK, Miocinovic R, Patel AR, et al.Irreversible Electroporation for Prostate Tissue Ablation in Patients with Intermediate-risk Prostate Cancer: Results from the PRESERVE Trial. Eur Urol*. 2025:S0302-2838(25)00346-X. doi:10.1016/j.eururo.2025.06.003
- AngioDynamics receives FDA clearance for the NanoKnife System for prostate