Prostate CancerPhase 2NCT01835977
Multi-Center Randomized Clinical Trial Irreversible Electroporation for the Ablation of Localized Prostate Cancer
A Phase 2 study testing Irreversible Electroporation (Nanoknife) in people with Prostate Cancer, run by Clinical Research Office of the Endourological Society.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Irreversible Electroporation (Nanoknife)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jan 2025
- Phase
- Phase 2
- 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 50 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
About this study
Official title: Multi-Center Randomized Clinical Two Arm Intervention Study Evaluating Irreversible Electroporation for the Ablation of Localized Prostate Cancer
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)
Read more
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.
- Conditions
- Prostate Cancer
- Being tested
- Irreversible Electroporation (Nanoknife)
- Keywords
- Focal therapy, Irreversible electroporation, Unilateral 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 Electroporation (Nanoknife)Device
Also called Nanoknife
| Study group | Role | What they receive |
|---|---|---|
| Focal ablation | Active comparator | Focal ablation of unilateral histopathologically confirmed, organ confined prostate cancer using IRE Receives: Device: Irreversible Electroporation (Nanoknife) |
| Extended ablation | Active comparator | Extended ablation unilateral histopathologically confirmed, organ confined prostate cancer using IRE Receives: Device: Irreversible Electroporation (Nanoknife) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 years
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startJun 2015
- Primary completion30 Jan 2020
- Study completionJan 2025 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Office of the Endourological Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean de la Rosette, MD, PhD, Study chair, Clinical Research Office of the Endourological Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835977
- Sponsor's protocol ID
- 2013249
- Status last verified
- Dec 2020
- First submitted
- 8 Apr 2013
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36723911Scheltema 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.
PubMed 27150293
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Randomized Clinical Two Arm Intervention Study Evaluating Irreversible Electroporation for the Ablation of Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT01835977
- Acronym / sponsor ID
- 2013249
- Conditions
- Prostate Cancer
- Keywords
- Focal therapy, Irreversible electroporation, Unilateral prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Clinical Research Office of the Endourological SocietyUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- Jan 2025 (estimated)
- First posted
- 19 Apr 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focal ablation | Active comparator | Device: Irreversible Electroporation (Nanoknife)Focal ablation of unilateral histopathologically confirmed, organ confined prostate cancer using IRE |
| Extended ablation | Active comparator | Device: Irreversible Electroporation (Nanoknife)Extended ablation unilateral histopathologically confirmed, organ confined prostate cancer using IRE |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 Electroporation (Nanoknife)Also: Nanoknife | Device | Extended ablation, Focal ablation |
Primary outcome
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).
1 secondary outcome
Oncological efficacy IRE ablation of prostate cancer.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Derived from this study: PubMed 36723911Zhang 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.
- Derived from this study: PubMed 27150293Scheltema 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 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.
Jean de la Rosette, MD, PhD study chair
Clinical Research Office of the Endourological Society
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irreversible Electroporation (Nanoknife) in people with Prostate Cancer, run by Clinical Research Office of the Endourological Society.
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 4 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Patient experience (side-effects and quality of life) after IRE ablation of prostate cancer (time frame: 5 years). 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 NCT01835977, 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 16 Dec 2020.