Multi-Center Randomized Clinical Trial Irreversible Electroporation for the Ablation of Localized Prostate Cancer

December 11, 2020 updated by: Clinical Research Office of the Endourological Society

Multi-Center Randomized Clinical Two Arm Intervention Study Evaluating Irreversible Electroporation for the Ablation of Localized Prostate Cancer

Multi-centre Randomized Clinical Trial: 106 patients with confirmed unilateral high-volume low risk (Gleason score 3 + 3) or intermediate risk prostate cancer (Gleason score 3 + 4) will undergo an IRE treatment. These patients will be randomized into one of the two groups of the study.

Group 1: Focal ablation of the prostate at the side of the positive biopsies (focal-ablation) Group 2: Extended ablation of the prostate (extended ablation)

Patients will have an ultrasound of the prostate and the imaging data will be entered into the Planning Software system of the IRE-device. The volume of the prostate is measured and a specified ablation zone will be determined. The patients will be admitted for overnight stay in the hospital on the morning of the scheduled IRE procedure. The IRE will be performed under general anaesthetic and the specified zone identified in the planning stage will be ablated. Two to four IRE electrode needles will be placed into the prostate under ultrasound image guidance with a perineal approach using a brachytherapy grid. 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 day post-operatively, 1 month, 3 months, 6 months and 1, 2 and 3 year(s) post IRE.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 2

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

50 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria

  1. Histologically confirmed organ-confined unilateral prostate cancer with adjacent positive biopsies on transperineal template prostate biopsies or MRI targeted biopsies in combination with systematic biopsies (clinical stage T1c-T2b)
  2. Gleason sum score 6 or 7
  3. PSA <15 ng/ml or PSA > 15 ng/mL counselled with caution
  4. Life expectancy of > 10 years

Exclusion Criteria

  1. Bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial thromboplastin time (PTT) > 34 seconds, and Platelet Count < 140/uL
  2. No ability to stop anticoagulant or anti-platelet therapy for 7 days prior the procedure.
  3. Active urinary tract infection (UTI)
  4. History of bladder neck contracture
  5. Anaesthesia Surgical Assignment category IV or greater
  6. History of inflammatory bowel disease
  7. Concurrent major debilitating illness
  8. Prior or concurrent malignancy except for basal cell carcinoma of the skin
  9. Cardiac history including arrhythmias, ICD or pacemaker
  10. Prostate calcifications greater than 5 mm.
  11. Biologic or chemotherapy for prostate cancer
  12. Hormonal therapy for prostate cancer within 6 months prior to procedure
  13. Previous radiation to pelvis
  14. Transurethral resection of the prostate / Urethral stent
  15. Prior major rectal surgery (except haemorrhoids)

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Focal ablation
Focal ablation of unilateral histopathologically confirmed, organ confined prostate cancer using IRE
Device: Irreversible Electroporation (Nanoknife)
Other Names:
  • Nanoknife
ACTIVE_COMPARATOR: Extended ablation
Extended ablation unilateral histopathologically confirmed, organ confined prostate cancer using IRE
Device: Irreversible Electroporation (Nanoknife)
Other Names:
  • Nanoknife

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient experience (side-effects and quality of life) after IRE ablation of prostate cancer
Time Frame: 5 years
To determine post procedural side-effects and Quality of life measured by International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF) and Functional Assessment of Cancer Therapy-Prostate (FACT-P).
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oncological efficacy IRE ablation of prostate cancer.
Time Frame: 5 years

To determine if IRE focal ablation procedure is as effective as extended ablation measured by PSA, standardised transrectal biopsies and MRI findings in follow-up.

To determine accurateness of ablation zone detection by MRI.
5 years

Collaborators and Investigators

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

Sponsor

Clinical Research Office of the Endourological Society

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

June 1, 2015

Primary Completion (ACTUAL)

January 30, 2020

Study Completion (ANTICIPATED)

January 1, 2025

Study Registration Dates

First Submitted

April 8, 2013

First Submitted That Met QC Criteria

April 18, 2013

First Posted (ESTIMATE)

April 19, 2013

Study Record Updates

Last Update Posted (ACTUAL)

December 16, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013249

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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