This study will evaluate the safety and effectiveness of using Irreversible Electroporation (IRE) for the treatment of symptomatic benign prostatic hyperplasia (BPH).
Male, age ≥50 years.
Clinical diagnosis of symptomatic benign prostatic hyperplasia (BPH).
International Prostate Symptom Score (IPSS) ≥13 at screening.
Peak urinary flow rate (Qmax) ≤12 mL/sec on non-catheterized free flow with voided volume ≥125 mL.
Patients with ≥ Grade Group 2 prostate cancer (≥ Gleason score 7).
Patients with Grade Group 1 prostate cancer (Gleason score 6) on active surveillance for less than 1 year.
Patients with PSA ≥10 ng/mL or PSA density ≥0.15 ng/mL2.
Prior surgical or minimally invasive intervention for BPH (e.g., TURP, Rezūm™, UroLift®, laser therapy).
Single group
Irreversible Electroporation
DeviceTreatment with the NanoKnife System for ablation of prostate tissue. The procedure will be performed under general anesthesia using transrectal ultrasound (TRUS) guidance. Electrodes will be placed transperineally into predefined treatment zones of the prostate based on imaging and prostate anatomy. Treatment planning will be tailored to target the transition zone bilaterally while preserving key structures, including the neurovascular bundles, external sphincter, and urethra. Electrical pulses will be delivered according to device specifications to achieve focal non-thermal ablation of tissue.
Incidence and severity of device-related adverse events (AEs) through 6 months post-procedure
The primary safety endpoint is the incidence and severity of device-related adverse events (AEs) through 6 months post-procedure, categorized using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Mean change in International Prostate Symptom Score (IPSS) from baseline to 6 months post-procedure
The primary effectiveness endpoint is the mean change in International Prostate Symptom Score (IPSS) from baseline to 6 months post-procedure, assessing improvement in lower urinary tract symptoms attributable to benign prostatic hyperplasia (BPH)
Technical success
The technical success of the procedure, defined to be successful energy delivery per the treating physician
Incidence and severity of device-related adverse events (AEs) through 12 months post-procedure
The incidence and severity of device-related adverse events (AEs) through 12 months post-procedure, categorized using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Incidence, relatedness, seriousness, and severity of all adverse events (AEs) through 6 months post-procedure
The incidence, relatedness, seriousness, and severity of all adverse events (AEs) through 6 months post-procedure, categorized using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Incidence, relatedness, seriousness, and severity of all adverse events (AEs) through 12 months post-procedure
The incidence, relatedness, seriousness, and severity of all adverse events (AEs) through 12 months post-procedure, categorized using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
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