Multi-Center Randomized Clinical Trial Irreversible Electroporation for the Ablation of Localized Prostate Cancer
1 other identifier
interventional
106
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Jun 2015
Longer than P75 for phase_2 prostate-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2013
CompletedFirst Posted
Study publicly available on registry
April 19, 2013
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedDecember 16, 2020
December 1, 2020
4.7 years
April 8, 2013
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
5 years
Secondary Outcomes (1)
Oncological efficacy IRE ablation of prostate cancer.
5 years
Study Arms (2)
Focal ablation
ACTIVE COMPARATORFocal ablation of unilateral histopathologically confirmed, organ confined prostate cancer using IRE
Extended ablation
ACTIVE COMPARATORExtended ablation unilateral histopathologically confirmed, organ confined prostate cancer using IRE
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 36723911DERIVEDScheltema 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.
PMID: 27150293DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jean de la Rosette, MD, PhD
Clinical Research Office of the Endourological Society
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2013
First Posted
April 19, 2013
Study Start
June 1, 2015
Primary Completion
January 30, 2020
Study Completion
January 1, 2025
Last Updated
December 16, 2020
Record last verified: 2020-12