Prostate CancerPhase 1NCT01790451
Safety and Efficacy of Irreversible Electroporation in Ablation of Prostate Cancer in Humans
A Phase 1 study testing Irreversible Electroporation in people with Prostate Cancer, run by Clinical Research Office of the Endourological Society at 1 site in Netherlands.
Trial summary
Up to 16 patients with confirmed low- or intermediate risk prostate cancer scheduled for a radical prostatectomy will be asked to have the Irreversible Electroporation (IRE) procedure approximately 30 days prior to the prostatectomy. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Irreversible Electroporation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2013to Oct 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with prostate cancer who are indicated to undergo a radical prostatectomy
- Life expectancy of > 10 years
- Able to visualize prostate gland adequately on transrectal US imaging during enrolment evaluation
- No prostate calcification greater than 5 mm
- Ability of subject to stop anticoagulant and anti-platelet therapy for 7 days prior and 7 days post procedure
Who cannot join
- Other Conditions/Status
- Bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial thromboplastin time (PTT) > 34 seconds, and Platelet Count < 140/microliter (uL)
- Active urinary tract infection (UTI)
- History of bladder neck contracture
- Anaesthesia Surgical Assignment, category IV or greater
- History of inflammatory bowel disease
Show all 18Show fewer
- Concurrent major debilitating illness
- Prior or concurrent malignancy
- Cardiac History
- Implantable cardioverter-defibrillator (ICD) / Pacemaker
- Prior or current therapies
- Biologic therapy for prostate cancer
- Chemotherapy for prostate cancer
- Hormonal therapy for prostate cancer within 3 months of procedure
- Radiotherapy for prostate cancer
- Transurethral prostatectomy (TURP), urethral stent
- Prior major rectal surgery (except haemorrhoids)
- Inability or unwillingness to tolerate temporary cessation of concurrent anticoagulation therapy or anti-platelet drugs for a period of 7days prior to procedure and up to 7 days after procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Efficacy of Irreversible Electroporation for the Ablation of Prostate Cancer Assessed by Procedural Related Side Effects and Post Prostatectomy Histology: A Prospective Human In-Vivo Study.
Up to 16 patients with confirmed low- or intermediate risk prostate cancer scheduled for a radical prostatectomy will be asked to have the Irreversible Electroporation (IRE) procedure approximately 30 days prior to the prostatectomy. Ablation with IRE will be performed using similar planning criteria, procedure protocol, instruments and software used for brachytherapy, a conventional targeted radiation therapy where radioactive seeds are implanted into prostate tumours. Patients will have an ultrasound of the prostate and the imaging data will be entered into the Planning Software system. The volume of the prostate is measured and a specified ablation zone will be determined. The IRE will be performed under general anaesthetic and the specified zone identified in the planning stage will be ablated. Four IRE electrode needles will be placed into the prostate under ultrasound image guidance. 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 week, 2 weeks post IRE, pre- prostatectomy, post prostatectomy and 1 week post prostatectomy. The safety data collection is at 2 weeks post IRE. Before the IRE procedure, patients will have a Magnetic Resonance Imaging (MRI) and Contrast Enhanced Ultrasound (CEUS) of the prostate. The patients will have their scheduled prostatectomy at approximately 30 days after the IRE procedure. Pre-prostatectomy, the ablation zone will be radiologically assessed by a control MRI/CEUS. Post prostatectomy, efficacy of ablation will be determined by histological examination of the prostate by the Pathology Department and measured as complete or incomplete ablation.
The primary outcome is safety as measured by the composite of procedural device and post procedural adverse events, measured with the Common Terminology Criteria for Adverse Events v 4 (CTCAE), Expanded Prostate Cancer Index Composite (EPIC) score, International Prostate Symptom Score (IPSS) or required catheterization time and International Index of Erectile Function (IIEF) and efficacy of ablation determined by histological examination post prostatectomy. Secondary outcomes will be patients procedure satisfaction measured by patient satisfaction questionnaire, post procedural pain management and Visual Analogue Scale (VAS) pain score, time to ambulation, length of hospital stay.
- Conditions
- Prostate Cancer
- Being tested
- Irreversible Electroporation
- Keywords
- focal therapy, irreversible electroporation, prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irreversible ElectroporationProcedure or surgery
Also called Nanoknife
| Study group | Role | What they receive |
|---|---|---|
| peripheral ablation | Active comparator | an ablation of the peripheral area of the prostate Receives: Procedure: Irreversible Electroporation |
| More central ablation | Active comparator | an ablation, more centrally, in proximity of the urethra Receives: Procedure: Irreversible Electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety IRE ablation procedure
To determine if the IRE ablation procedure is safe as measured by the composite number of procedural, device and post procedural adverse events measured with the CTCAE proforma.
Measured: 1 year
Efficacy
To determine if complete ablation of the specified targeted ablation zone is achieved as measured by histopathology assessment.
Measured: 1 year
Secondary outcomes (3)
Side effects
To determine if procedural side effects associated with current treatments for prostate cancer, mainly incontinence, erectile dysfunction and bowel damage are avoided as measured by the validated prostate cancer scores -EPIC, IIEF-5 and IPSS or time of CAD required.
- To determine patient satisfaction and comfort measured by Patient Satisfaction Questionnaire, post procedural pain management and pain score, time to ambulation, length of hospital stay.
- To determine accurateness of ablation zone detection by MRI/CEUS.
Measured: 1 year
Quality of Life
To determine patient satisfaction and comfort measured by Patient Satisfaction Questionnaire, post procedural pain management and pain score, time to ambulation, length of hospital stay.
Measured: 1 year
Ablation Zone Detection
To determine accurateness of ablation zone detection by MRI/CEUS
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Office of the Endourological Society
- Sponsor type
- University, hospital or other
- Collaborators
- Angiodynamics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790451
- Sponsor's protocol ID
- 2012-252
- Status last verified
- Aug 2014
- First submitted
- 8 Feb 2013
- Last updated
- 20 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van den Bos W, de Bruin DM, Jurhill RR, Savci-Heijink CD, Muller BG, Varkarakis IM, Skolarikos A, Zondervan PJ, Laguna-Pes MP, Wijkstra H, de Reijke TM, de la Rosette JJ. The correlation between the electrode configuration and histopathology of irreversible electroporation ablations in prostate cancer patients. World J Urol. 2016 May;34(5):657-64. doi: 10.1007/s00345-015-1661-x. Epub 2015 Aug 22.
PubMed 26296371van den Bos W, de Bruin DM, Muller BG, Varkarakis IM, Karagiannis AA, Zondervan PJ, Laguna Pes MP, Veelo DP, Savci Heijink CD, Engelbrecht MRW, Wijkstra H, de Reijke TM, de la Rosette JJMCH. The safety and efficacy of irreversible electroporation for the ablation of prostate cancer: a multicentre prospective human in vivo pilot study protocol. BMJ Open. 2014 Oct 29;4(10):e006382. doi: 10.1136/bmjopen-2014-006382.
PubMed 25354827
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Irreversible Electroporation for the Ablation of Prostate Cancer Assessed by Procedural Related Side Effects and Post Prostatectomy Histology: A Prospective Human In-Vivo Study.
- ClinicalTrials.gov ID
- NCT01790451
- Acronym / sponsor ID
- 2012-252
- Conditions
- Prostate Cancer
- Keywords
- focal therapy, irreversible electroporation, prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Clinical Research Office of the Endourological SocietyUniversity, hospital or other
- Collaborators
- Angiodynamics, Inc.
- Study start
- Aug 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Up to 16 patients with confirmed low- or intermediate risk prostate cancer scheduled for a radical prostatectomy will be asked to have the Irreversible Electroporation (IRE) procedure approximately 30 days prior to the prostatectomy. Ablation with IRE will be performed using similar planning criteria, procedure protocol, instruments and software used for brachytherapy, a conventional targeted radiation therapy where radioactive seeds are implanted into prostate tumours. Patients will have an ultrasound of the prostate and the imaging data will be entered into the Planning Software system. The volume of the prostate is measured and a specified ablation zone will be determined. The IRE will be performed under general anaesthetic and the specified zone identified in the planning stage will be ablated. Four IRE electrode needles will be placed into the prostate under ultrasound image guidance. 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 week, 2 weeks post IRE, pre- prostatectomy, post prostatectomy and 1 week post prostatectomy. The safety data collection is at 2 weeks post IRE. Before the IRE procedure, patients will have a Magnetic Resonance Imaging (MRI) and Contrast Enhanced Ultrasound (CEUS) of the prostate. The patients will have their scheduled prostatectomy at approximately 30 days after the IRE procedure. Pre-prostatectomy, the ablation zone will be radiologically assessed by a control MRI/CEUS. Post prostatectomy, efficacy of ablation will be determined by histological examination of the prostate by the Pathology Department and measured as complete or incomplete ablation.
The primary outcome is safety as measured by the composite of procedural device and post procedural adverse events, measured with the Common Terminology Criteria for Adverse Events v 4 (CTCAE), Expanded Prostate Cancer Index Composite (EPIC) score, International Prostate Symptom Score (IPSS) or required catheterization time and International Index of Erectile Function (IIEF) and efficacy of ablation determined by histological examination post prostatectomy. Secondary outcomes will be patients procedure satisfaction measured by patient satisfaction questionnaire, post procedural pain management and Visual Analogue Scale (VAS) pain score, time to ambulation, length of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| peripheral ablation | Active comparator | Procedure: Irreversible Electroporationan ablation of the peripheral area of the prostate |
| More central ablation | Active comparator | Procedure: Irreversible Electroporationan ablation, more centrally, in proximity of the urethra |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with prostate cancer who are indicated to undergo a radical prostatectomy
- Life expectancy of > 10 years
- Able to visualize prostate gland adequately on transrectal US imaging during enrolment evaluation
- No prostate calcification greater than 5 mm
- Ability of subject to stop anticoagulant and anti-platelet therapy for 7 days prior and 7 days post procedure
Key exclusion criteria (18 listed)
- Other Conditions/Status
- Prior or current therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irreversible ElectroporationAlso: Nanoknife | Procedure or surgery | More central ablation, peripheral ablation |
Primary outcome
Safety IRE ablation procedure
Time frame: 1 year
To determine if the IRE ablation procedure is safe as measured by the composite number of procedural, device and post procedural adverse events measured with the CTCAE proforma.
Efficacy
Time frame: 1 year
To determine if complete ablation of the specified targeted ablation zone is achieved as measured by histopathology assessment.
3 secondary outcomes
Side effects
Time frame: 1 year
Quality of Life
Time frame: 1 year
Ablation Zone Detection
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
- Derived from this study: PubMed 26296371van den Bos W, de Bruin DM, Jurhill RR, Savci-Heijink CD, Muller BG, Varkarakis IM, Skolarikos A, Zondervan PJ, Laguna-Pes MP, Wijkstra H, de Reijke TM, de la Rosette JJ. The correlation between the electrode configuration and histopathology of irreversible electroporation ablations in prostate cancer patients. World J Urol. 2016 May;34(5):657-64. doi: 10.1007/s00345-015-1661-x. Epub 2015 Aug 22.
- Derived from this study: PubMed 25354827van den Bos W, de Bruin DM, Muller BG, Varkarakis IM, Karagiannis AA, Zondervan PJ, Laguna Pes MP, Veelo DP, Savci Heijink CD, Engelbrecht MRW, Wijkstra H, de Reijke TM, de la Rosette JJMCH. The safety and efficacy of irreversible electroporation for the ablation of prostate cancer: a multicentre prospective human in vivo pilot study protocol. BMJ Open. 2014 Oct 29;4(10):e006382. doi: 10.1136/bmjopen-2014-006382.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Irreversible Electroporation in people with Prostate Cancer, run by Clinical Research Office of the Endourological Society at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety IRE ablation procedure (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01790451, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2015.