Irreversible Electroporation Versus Standard Medication for Benign Prostatic Obstruction

The Safety and Efficacy of Irreversible Electroporation Versus Standard Medication for the Treatment of Benign Prostatic Obstruction: a Randomized Controlled Trial

Irreversible electroporation (IRE) is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane. It has been verified to be safe on the treatment of prostate, lung, liver and kidney masses. The present is a randomized, controlled trial, with a main purpose of looking into the safety and feasibility of irreversible electroporation for patients with benign prostatic obstruction.

Study Overview

• Status: Unknown
• Conditions: Lower Urinary Tract Symptoms
• Intervention / Treatment: Device: Irreversible electroporation; Drug: Standard Medication

Detailed Description

Benign prostatic obstruction (BPO) is the main reason to cause lower urinary tract symptoms (LUTS) in aged male. Oral medications, such as,α1-adrenoceptor antagonist and 5α-reductase inhibitors are the mainstay treatment options. However, some patients can not tolerate long-term use, due to either side effects or limited efficacy. Though transurethral resection or enucleation of prostate usually achieve significant symptom improvement, it's an end stage procedure and it is only reserved for carefully selected patients.

The development of focal ablative therapy yields minimally invasive treatment option for primary tumors such as the liver, lung, pancreas, kidney, and prostate. Among the novel techniques are cryoablation, radiofrequency ablation (RFA), microwave ablation, and high-intensity focused ultrasonography. Irreversible electroporation (IRE) is a one of the ablation modalities using electric pulses to create nanoscale defects in the cell membrane. IRE is not dependent on thermal energy and is therefore causing minimum damage to the blood vessels, nerves and tissue architecture. The present is a randomized, controlled trial, with a main purpose of looking into the safety and feasibility of irreversible electroporation for patients with benign prostatic obstruction.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Changhai Hospital
      • Contact: Haifeng Wang, MD, PhD; Phone Number: 13681750891; Email: 446720864@qq.com
      • Contact: Qi-Xiang Song, MD, PhD; Phone Number: 15021223013; Email: rex_song918@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Male, 45 years or older.
2. The presence of voiding symptoms, i.e. slow stream, intermittent stream, hesitancy, straining, etc.
3. Qmax ≥ 5 mL/s and ≤ 15 mL/s with minimum voided volume of 125 mL or more during flow study.
4. The presence of bladder outlet obstruction during pressure-flow study.
5. International Prostatic Symptom Score (IPSS) ≥ 12 at screening.
6. Prostate volume ≥ 30 ml (using a transrectal ultrasound approach).
7. Total serum prostatic specific antigen (PSA) ≥ 1.5 ng/mL and ≤ 10 ng/mL at screening.
8. Subject is able to communicate and complete the questionnaires properly.
9. Written informed consent.

Exclusion Criteria:

1. Diagnosis or suspicion of bladder, prostate, urethral or pelvic tumor.
2. Patients with arrhythmia or history of cardiac pacemaker implantation.
3. Known lower urinary tract or pelvic surgical history.
4. Voiding symptoms as a result of urethral stricture, stone diseases, chronic prostatitis, space-occupying lesions etc.
5. Known neurogenic or congenital lower urinary tract dysfunction.
6. Rigid or flexible cystoscopy examination within the past 7 days at screening.
7. Existence of anatomical abnormalities of the urinary tract (e.g. diverticulum of the bladder or urethra, ectopic ureteral orifice etc.).
8. The presence of acute conditions, such as, urinary tract infection, fever, heart failure etc.
9. Patients with poor compliance or cognitive competence.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Irreversible electroporation treatment; Subjects will receive irreversible electroporation of the prostate	Device: Irreversible electroporation; The subject will receive Irreversible electroporation procedure which is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane.
Active Comparator: standard medication group; Subjects will receive either α-blocker or 5α reductase monotherapy or combination therapy.	Drug: Standard Medication; The subject will be prescribed with α-blocker or/and 5α-reductase inhibitors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes of maximum flow rate (ml/s) between baseline and during follow-up	Maximum flow rate will be measured using urinary flow study	Measured at baseline and 1, 3, 6 months during follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes of IPSS scores between baseline and during follow-up	Measured using a standard IPSS scoring system	Measured at baseline and 1, 3, 6 months during follow-up
The changes of IIEF scores between baseline and during follow-up	Measured using a standard IIEF scoring system	Measured at baseline and 1, 3, 6 months during follow-up
The changes of maximum detrusor pressure at maximum flow rate between baseline and during follow-up	The data will be captured during pressure flow study	Measured at baseline and 3, 6 months during follow-up
The changes of post void residual volume (ml) between baseline and follow-up	Post void residual volume (ml) will be measured via ultrasound	Measured at baseline and 1, 3, 6 months during follow-up
The changes of prostate volume (ml) between baseline and follow-up	Prostate volume (ml) will be measured using transrectal prostate ultrasound and calculated as: prostate volume (ml) = length (mm) * width (mm) * height (mm) * 0.52.	Measured at baseline and 1, 3, 6 during follow-up

Collaborators and Investigators

• Sponsor: Changhai Hospital

Publications and helpful links

General Publications

• Wagstaff PG, Buijs M, van den Bos W, de Bruin DM, Zondervan PJ, de la Rosette JJ, Laguna Pes MP. Irreversible electroporation: state of the art. Onco Targets Ther. 2016 Apr 22;9:2437-46. doi: 10.2147/OTT.S88086. eCollection 2016.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): January 31, 2019
• Study Completion (Anticipated): May 30, 2019

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: male; irreversible electroporation; benign prostatic obstruction; urodynamics; lower urinary tract symptoms
• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: IRE-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No