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Trial record 3 of 10 for:    irreversible Electroporation for the Ablation of Prostate Cancer
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Multi-Center Randomized Clinical Trial Irreversible Electroporation for the Ablation of Localized Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01835977
Recruitment Status : Active, not recruiting
First Posted : April 19, 2013
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Clinical Research Office of the Endourological Society

Study Description
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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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Irreversible Electroporation (Nanoknife) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Multi-Center Randomized Clinical Two Arm Intervention Study Evaluating Irreversible Electroporation for the Ablation of Localized Prostate Cancer
Study Start Date : June 2015
Actual Primary Completion Date : January 30, 2020
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Focal ablation
Focal ablation of unilateral histopathologically confirmed, organ confined prostate cancer using IRE
 Device: Irreversible Electroporation (Nanoknife)
Other Name: Nanoknife
Active Comparator: Extended ablation
Extended ablation unilateral histopathologically confirmed, organ confined prostate cancer using IRE
 Device: Irreversible Electroporation (Nanoknife)
Other Name: Nanoknife


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835977


Sponsors and Collaborators
Clinical Research Office of the Endourological Society
Investigators
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Study Chair: Jean de la Rosette, MD, PhD Clinical Research Office of the Endourological Society
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Clinical Research Office of the Endourological Society
ClinicalTrials.gov Identifier: NCT01835977    
Other Study ID Numbers: 2013249
First Posted: April 19, 2013    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Keywords provided by Clinical Research Office of the Endourological Society:
Focal therapy
Irreversible electroporation
Unilateral prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases