Irreversible Electroporation Versus Standard Medication for Benign Prostatic Obstruction

Sponsor

Changhai Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03448510

Collaborator

(none)

100

Enrollment

Location

Arms

13.9

Anticipated Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lower Urinary Tract Symptoms	Device: Irreversible electroporation Drug: Standard Medication	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Irreversible electroporation (IRE) is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane.Irreversible electroporation (IRE) is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane.

Masking:

Single (Outcomes Assessor)

Masking Description:

The data will be analyzed in a blinded manner.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2018

Anticipated Primary Completion Date :

Jan 31, 2019

Anticipated Study Completion Date :

May 30, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

The changes of IPSS scores between baseline and during follow-up [Measured at baseline and 1, 3, 6 months during follow-up]
Measured using a standard IPSS scoring system
The changes of IIEF scores between baseline and during follow-up [Measured at baseline and 1, 3, 6 months during follow-up]
Measured using a standard IIEF scoring system
The changes of maximum detrusor pressure at maximum flow rate between baseline and during follow-up [Measured at baseline and 3, 6 months during follow-up]
The data will be captured during pressure flow study
The changes of post void residual volume (ml) between baseline and follow-up [Measured at baseline and 1, 3, 6 months during follow-up]
Post void residual volume (ml) will be measured via ultrasound
The changes of prostate volume (ml) between baseline and follow-up [Measured at baseline and 1, 3, 6 during 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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