Multi-Center Randomized Clinical Trial Irreversible Electroporation for the Ablation of Localized Prostate Cancer
NCT ID: NCT01835977
Last Updated: 2020-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
106 participants
INTERVENTIONAL
2015-06-30
2025-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Focal ablation
Focal ablation of unilateral histopathologically confirmed, organ confined prostate cancer using IRE
Irreversible Electroporation (Nanoknife)
Extended ablation
Extended ablation unilateral histopathologically confirmed, organ confined prostate cancer using IRE
Irreversible Electroporation (Nanoknife)
Interventions
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Irreversible Electroporation (Nanoknife)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
50 Years
100 Years
MALE
No
Sponsors
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Clinical Research Office of the Endourological Society
OTHER
Responsible Party
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Principal Investigators
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Jean de la Rosette, MD, PhD
Role: STUDY_CHAIR
Clinical Research Office of the Endourological Society
Countries
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References
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Zhang K, Teoh J, Laguna P, Dominguez-Escrig J, Barret E, Ramon-Borja JC, Muir G, Bohr J, de Reijke TM, Pelechano Gomez P, Ng CF, Sanchez-Salas R, de la Rosette J. Effect of Focal vs Extended Irreversible Electroporation for the Ablation of Localized Low- or Intermediate-Risk Prostate Cancer on Early Oncological Control: A Randomized Clinical Trial. JAMA Surg. 2023 Apr 1;158(4):343-349. doi: 10.1001/jamasurg.2022.7516.
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.
Related Links
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Related Info
Other Identifiers
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2013249
Identifier Type: -
Identifier Source: org_study_id