Safety and Efficacy of Irreversible Electroporation in Ablation of Prostate Cancer in Humans

February 19, 2015 updated by: Clinical Research Office of the Endourological Society

The Safety and Efficacy of Irreversible Electroporation for the Ablation of Prostate Cancer Assessed by Procedural Related Side Effects and Post Prostatectomy Histology: A Prospective Human In-Vivo Study.

Up to 16 patients with confirmed low- or intermediate risk prostate cancer scheduled for a radical prostatectomy will be asked to have the Irreversible Electroporation (IRE) procedure approximately 30 days prior to the prostatectomy. Ablation with IRE will be performed using similar planning criteria, procedure protocol, instruments and software used for brachytherapy, a conventional targeted radiation therapy where radioactive seeds are implanted into prostate tumours. Patients will have an ultrasound of the prostate and the imaging data will be entered into the Planning Software system. The volume of the prostate is measured and a specified ablation zone will be determined. The IRE will be performed under general anaesthetic and the specified zone identified in the planning stage will be ablated. Four IRE electrode needles will be placed into the prostate under ultrasound image guidance. When the needles are in place, electric pulses of one to two minutes duration are used to ablate the specified zone. The total procedure time will be approximately 1 hour. Safety data will be collected and patients will be followed up at 1 week, 2 weeks post IRE, pre- prostatectomy, post prostatectomy and 1 week post prostatectomy. The safety data collection is at 2 weeks post IRE. Before the IRE procedure, patients will have a Magnetic Resonance Imaging (MRI) and Contrast Enhanced Ultrasound (CEUS) of the prostate. The patients will have their scheduled prostatectomy at approximately 30 days after the IRE procedure. Pre-prostatectomy, the ablation zone will be radiologically assessed by a control MRI/CEUS. Post prostatectomy, efficacy of ablation will be determined by histological examination of the prostate by the Pathology Department and measured as complete or incomplete ablation.

The primary outcome is safety as measured by the composite of procedural device and post procedural adverse events, measured with the Common Terminology Criteria for Adverse Events v 4 (CTCAE), Expanded Prostate Cancer Index Composite (EPIC) score, International Prostate Symptom Score (IPSS) or required catheterization time and International Index of Erectile Function (IIEF) and efficacy of ablation determined by histological examination post prostatectomy. Secondary outcomes will be patients procedure satisfaction measured by patient satisfaction questionnaire, post procedural pain management and Visual Analogue Scale (VAS) pain score, time to ambulation, length of hospital stay.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • AMC University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Patients with prostate cancer who are indicated to undergo a radical prostatectomy
  2. Life expectancy of > 10 years
  3. Able to visualize prostate gland adequately on transrectal US imaging during enrolment evaluation
  4. No prostate calcification greater than 5 mm
  5. Ability of subject to stop anticoagulant and anti-platelet therapy for 7 days prior and 7 days post procedure

Exclusion Criteria:

  1. Other Conditions/Status

    1. Bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial thromboplastin time (PTT) > 34 seconds, and Platelet Count < 140/microliter (uL)
    2. Active urinary tract infection (UTI)
    3. History of bladder neck contracture
    4. Anaesthesia Surgical Assignment, category IV or greater
    5. History of inflammatory bowel disease
    6. Concurrent major debilitating illness
    7. Prior or concurrent malignancy
    8. Cardiac History
    9. Implantable cardioverter-defibrillator (ICD) / Pacemaker

  2. Prior or current therapies

    1. Biologic therapy for prostate cancer
    2. Chemotherapy for prostate cancer
    3. Hormonal therapy for prostate cancer within 3 months of procedure
    4. Radiotherapy for prostate cancer
    5. Transurethral prostatectomy (TURP), urethral stent
    6. Prior major rectal surgery (except haemorrhoids)
    7. Inability or unwillingness to tolerate temporary cessation of concurrent anticoagulation therapy or anti-platelet drugs for a period of 7days prior to procedure and up to 7 days after procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: peripheral ablation
an ablation of the peripheral area of the prostate
Procedure: Irreversible Electroporation
Other Names:
  • Nanoknife
Active Comparator: More central ablation
an ablation, more centrally, in proximity of the urethra
Procedure: Irreversible Electroporation
Other Names:
  • Nanoknife

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety IRE ablation procedure
Time Frame: 1 year
To determine if the IRE ablation procedure is safe as measured by the composite number of procedural, device and post procedural adverse events measured with the CTCAE proforma.
1 year
Efficacy
Time Frame: 1 year
To determine if complete ablation of the specified targeted ablation zone is achieved as measured by histopathology assessment.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: 1 year

To determine if procedural side effects associated with current treatments for prostate cancer, mainly incontinence, erectile dysfunction and bowel damage are avoided as measured by the validated prostate cancer scores -EPIC, IIEF-5 and IPSS or time of CAD required.

b) To determine patient satisfaction and comfort measured by Patient Satisfaction Questionnaire, post procedural pain management and pain score, time to ambulation, length of hospital stay.

c) To determine accurateness of ablation zone detection by MRI/CEUS.
1 year
Quality of Life
Time Frame: 1 year
To determine patient satisfaction and comfort measured by Patient Satisfaction Questionnaire, post procedural pain management and pain score, time to ambulation, length of hospital stay.
1 year
Ablation Zone Detection
Time Frame: 1 year
To determine accurateness of ablation zone detection by MRI/CEUS
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Research Office of the Endourological Society

Collaborators

Angiodynamics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

February 8, 2013

First Submitted That Met QC Criteria

February 11, 2013

First Posted (Estimate)

February 13, 2013

Study Record Updates

Last Update Posted (Estimate)

February 20, 2015

Last Update Submitted That Met QC Criteria

February 19, 2015

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-252

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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