Irreversible Electroporation (IRE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)

N/ANot Yet RecruitingNCT07640776

Angiodynamics, Inc.40 enrolled

Overview

This study will evaluate the safety and effectiveness of using Irreversible Electroporation (IRE) for the treatment of symptomatic benign prostatic hyperplasia (BPH).

This study will be a prospective, non-randomized study in 40 subjects at up to five clinical sites in the United States. A total of 40 subjects will be treated with IRE and followed for evaluation of primary and secondary endpoints at 6 months post-treatment. Long-term follow-up will continue through 5 years post-treatment for secondary endpoints.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)

Interventions

Irreversible ElectroporationDEVICE

Treatment 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.

Eligibility

Sex: MALEMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male, age ≥50 years. 2. Clinical diagnosis of symptomatic benign prostatic hyperplasia (BPH). 3. International Prostate Symptom Score (IPSS) ≥13 at screening. 4. Peak urinary flow rate (Qmax) ≤12 mL/sec on non-catheterized free flow with voided volume ≥125 mL. 5. Post-void residual (PVR) ≤250 mL. 6. Prostate volume between 30 cc and 80 cc by transrectal ultrasound (TRUS) or Magnetic Resonance Imaging (MRI). 7. Willing and able to comply with all study procedures and follow-up requirements. 8. Able to provide written informed consent. 9. Life expectancy ≥10 years. Exclusion Criteria: 1. Patients with ≥ Grade Group 2 prostate cancer (≥ Gleason score 7). 2. Patients with Grade Group 1 prostate cancer (Gleason score 6) on active surveillance for less than 1 year. 3. Patients with PSA ≥10 ng/mL or PSA density ≥0.15 ng/mL2. 4. Prior surgical or minimally invasive intervention for BPH (e.g., TURP, Rezūm™, UroLift®, laser therapy). 5. Presence of urethral stricture or bladder neck contracture. 6. Patients with a history of pelvic radiation/irradiation. 7. Patients with compromised renal function (serum creatinine level \>1.8 mg/dL or upper-tract disease). 8. Obstructing median lobe intravesical prostatic protrusion (IPP) with \>1 cm assessed by TRUS or MRI. 9. Active urinary tract infection, prostatitis, or gross hematuria within 3 months of enrollment. 10. Active need of catheterization. 11. Known or suspected neurogenic bladder or underlying neurologic disease affecting bladder function (e.g., Parkinson's disease, multiple sclerosis, stroke with residual urinary symptoms). 12. History of bladder cancer or other urological malignancy. 13. Implanted electrical devices (e.g., pacemaker, defibrillator, neurostimulator) incompatible with IRE energy delivery. 14. Uncorrected bleeding diathesis or current therapeutic anticoagulation that cannot be safely interrupted. 15. Current use of BPH medications unless on a stable dose for ≥6 weeks (alpha-blockers, anticholinergics, beta-3 adrenergic agonists) or ≥6 months (5-alpha reductase inhibitors, phosphodiesterase type 5 inhibitors) prior to baseline, with no planned changes during study follow-up. 16. Prior rectal or pelvic surgery that may interfere with treatment delivery or evaluation. 17. Desire to preserve future fertility. 18. Severe or uncontrolled comorbidities (e.g., NYHA class III/IV heart failure, uncontrolled diabetes, severe pulmonary disease) that, in the opinion of the investigator, would increase study risk or confound outcomes. 19. Participation in another clinical trial involving an investigational drug or device within 30 days prior to enrollment. 20. Patients who are members of a vulnerable population, such as the cognitively challenged or incarcerated, that could expose them to undue influence, coercion, or inability to provide informed consent.

Outcomes

Primary Outcomes

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

Time frame: From treatment through 6 months post-procedure

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)

Time frame: From baseline through 6 months post-procedure

Secondary Outcomes

Technical success

The technical success of the procedure, defined to be successful energy delivery per the treating physician

Time frame: Immediately after the procedure

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

Time frame: From treatment through 12 months post-procedure

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

Time frame: From treatment through 6 months post-procedure

Central Contacts

Elizabeth Manning Sr. Director, Clinical Affairs

CONTACT

339-237-2765 liz.manning@angiodynamics.com

Data from ClinicalTrials.gov

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