The goal of this clinical trial is to investigate the safety and efficacy of Irreversible Electroporation (IRE) using NanoKnife technology in patients with intermediate-risk prostate cancer. This patient population was chosen because they would otherwise be treated with conventional therapies with high side effects. The main questions it aims to answer are:
1. Is the NanoKnife system is effective at damaging prostate tumour cells, and killing the cancer? 2. Are there any safety concerns with the procedure, or major side effects caused by the treatment?
Participants will undergo IRE treatment with the NanoKnife system, and then complete follow-up appointments for 12-months after the procedure.
Is greater than 50 years of age
Has at least a 10-year life expectancy
Has histologically confirmed organ-confined prostate cancer, clinical stage ≤ T2c
Has a PSA ≤ 15 ng/mL or PSA density < 0.15 ng/mL2 if PSA is > 15 ng/mL
Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium
Is unfit for anesthesia or has a contraindication for agents listed for paralysis
Has an active urinary tract infection (UTI)
Has a history of bladder neck contracture
Single group
Irreversible Electroporation (NanoKnife)
DeviceIrreversible Electroporation (IRE) using NanoKnife technology uses high voltage current pulses via probes placed around the prostate tumour via the perineum. The electricity damages the cell membranes rendering the cells dead. Hypothesized benefits of IRE over other focal therapy options include the ability to treat large or small lesions. Also, because the technology spares vessels, it can be used to treat prostate areas adjacent to sensitive structures (ie prostate apex near the sphincter and lateral peripheral zone near the neurovascular bundle). Finally, treatments take approximately 1-1.5 hours, thus the technology could be used to treat several patients per day.
Rate of negative in-field biopsy at 12 months
To determine the NanoKnife System's ablation effectiveness by measuring the negative in-field biopsy rate at 12 months
Incidence of adverse events by type and CTCAE v5.0 severity through 12 months
To determine the NanoKnife System's procedural and post-procedural safety profile by evaluation adverse event incidence, type, and severity through 12 months
Evaluation of clinically significant prostate cancer rate of development outside the ablation zone
To evaluate whether clinically significant prostate cancer will develop outside the ablation zone in men selected for focal IRE therapy as determined by positive prostate biopsy outside the ablation zone 12 months post treatment
Assessment of urinary function after NanoKnife System treatment by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite
Assessment of urinary function by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite (UCLA-EPIC) Urinary Domain and International Prostate Symptom Scores (IPSS) and IPSS Quality of Life2 (IPSS-QoL) scores.
Assessment of erectile function after NanoKnife System treatment by comparison of pre- and post-operative IIEF-15 potency scores
Assessment of erectile function by comparison of pre- and post-operative 15-Item International Index of Erectile Function (IIEF-15) potency scores.
Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics
To determine post-NanoKnife System treatment prostate-specific antigen (PSA) kinetics, including time to PSA nadir and post-nadir PSA stability
Evaluation of longer term effectiveness of focal IRE
To examine the rate of progression and re-intervention collected through standard of care follow-up for five years
Collection of data on possible delayed adverse events
To evaluate any delayed adverse events collected through standard of care for five years by type and CTCAE v5.0 severity
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