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

Primary Purpose

Prostate Cancer

Status
Active
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Irreversible Electroporation (Nanoknife)
Sponsored by
Clinical Research Office of the Endourological Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Focal therapy, Irreversible electroporation, Unilateral prostate cancer

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Focal ablation

    Extended ablation

    Arm Description

    Focal ablation of unilateral histopathologically confirmed, organ confined prostate cancer using IRE

    Extended ablation unilateral histopathologically confirmed, organ confined prostate cancer using IRE

    Outcomes

    Primary Outcome Measures

    Patient experience (side-effects and quality of life) after IRE ablation of prostate cancer
    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).

    Secondary Outcome Measures

    Oncological efficacy IRE ablation of prostate cancer.
    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.

    Full Information

    First Posted
    April 8, 2013
    Last Updated
    December 11, 2020
    Sponsor
    Clinical Research Office of the Endourological Society
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01835977
    Brief Title
    Multi-Center Randomized Clinical Trial Irreversible Electroporation for the Ablation of Localized Prostate Cancer
    Official Title
    Multi-Center Randomized Clinical Two Arm Intervention Study Evaluating Irreversible Electroporation for the Ablation of Localized Prostate Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    January 30, 2020 (Actual)
    Study Completion Date
    January 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Clinical Research Office of the Endourological Society

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    Focal therapy, Irreversible electroporation, Unilateral prostate cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    106 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Focal ablation
    Arm Type
    Active Comparator
    Arm Description
    Focal ablation of unilateral histopathologically confirmed, organ confined prostate cancer using IRE
    Arm Title
    Extended ablation
    Arm Type
    Active Comparator
    Arm Description
    Extended ablation unilateral histopathologically confirmed, organ confined prostate cancer using IRE
    Intervention Type
    Device
    Intervention Name(s)
    Irreversible Electroporation (Nanoknife)
    Other Intervention Name(s)
    Nanoknife
    Primary Outcome Measure Information:
    Title
    Patient experience (side-effects and quality of life) after IRE ablation of prostate cancer
    Description
    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).
    Time Frame
    5 years
    Secondary Outcome Measure Information:
    Title
    Oncological efficacy IRE ablation of prostate cancer.
    Description
    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.
    Time Frame
    5 years

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria 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) Gleason sum score 6 or 7 PSA <15 ng/ml or PSA > 15 ng/mL counselled with caution Life expectancy of > 10 years Exclusion Criteria Bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial thromboplastin time (PTT) > 34 seconds, and Platelet Count < 140/uL No ability to stop anticoagulant or anti-platelet therapy for 7 days prior the procedure. Active urinary tract infection (UTI) History of bladder neck contracture Anaesthesia Surgical Assignment category IV or greater History of inflammatory bowel disease Concurrent major debilitating illness Prior or concurrent malignancy except for basal cell carcinoma of the skin Cardiac history including arrhythmias, ICD or pacemaker Prostate calcifications greater than 5 mm. Biologic or chemotherapy for prostate cancer Hormonal therapy for prostate cancer within 6 months prior to procedure Previous radiation to pelvis Transurethral resection of the prostate / Urethral stent Prior major rectal surgery (except haemorrhoids)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jean de la Rosette, MD, PhD
    Organizational Affiliation
    Clinical Research Office of the Endourological Society
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27150293
    Citation
    Scheltema MJ, van den Bos W, de Bruin DM, Wijkstra H, Laguna MP, de Reijke TM, de la Rosette JJ. Focal vs extended ablation in localized prostate cancer with irreversible electroporation; a multi-center randomized controlled trial. BMC Cancer. 2016 May 5;16:299. doi: 10.1186/s12885-016-2332-z.
    Results Reference
    derived
    Links:
    URL
    http://www.croesoffice.org
    Description
    Related Info

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