Prostate CancerNCT03504995
Efficacy and Safety Assessment of IRE of Localized Prostate Cancer.
A study testing Focal irreversible electroporation of the prostate cancer in people with Prostate Cancer and Prostate Adenocarcinoma, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
The purpose of this study is to evaluate safety and short-term oncological efficacy of the NanoKnife Irreversible Electroporation System for localised prostate cancer. Irreversible electroporation (IRE) is the method of focal treatment for prostate cancer, which is already proven by FDA as method of the surgical… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma
- What is being tested?
- Focal irreversible electroporation of the prostate cancer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteRussia
- Study dates
- 19 Apr 2018to 30 Apr 2020
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Verified with MR-fusion biopsy localized Pca
- PSA < 15 ng/ml
- Gleason score 3+3=6; 3+4=7 OR Grade Group 1 and 2
- Life expectancy > 10 years
- No post-void residual urine or infravesical obstruction
Who cannot join
- patients with artificial cardiac pacemaker
- patients without rectum
- patients not eligible for general anesthesia
- PIRADS<3
- patients after primary Pca treatment
- hormonal therapy six months before the study
Show all 10Show fewer
- radiotherapy of pelvic organs
- urinary infection
- extracapsular Pca
- patients with metastatic lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety Assessment of Nanoknife (AngyoDynamics, USA) for Irreversible Electroporation (IRE) of Localized Prostate Cancer.
The purpose of this study is to evaluate safety and short-term oncological efficacy of the NanoKnife Irreversible Electroporation System for localised prostate cancer.
Irreversible electroporation (IRE) is the method of focal treatment for prostate cancer, which is already proven by FDA as method of the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.
Read the detailed description
Irreversible electroporation is a newly developed non-thermal tissue ablation technique in which short duration electrical fields are used to form permanent nanoscale defects in the cell membrane which leads to cell apoptosis. Thus, IRE is a non-thermal technique, which means that changes associated with tissue freezing or heating are not relevant.
Moreover, animal studies of IRE in the canine prostate have demonstrated that structures such as ejaculatory ducts, neurovascular bundles, blood vessels, and the urethra heal normally after ablation. The reason is that collagen matrix during treatment with IRE is not destroyed thus allowing for a large structures (blood vessels, nerves, etc.) to heal normally.
This study is a prospective and non-randomized with one group of 10 patients eligible for focal therapy of prostate cancer with IRE (eligibility defined by this protocol).
Before the surgery all patients will underwent transperineal MRI-fusion biopsy to localize the prostate cancer foci.
Objectives of the study: to asses safety of IRE in patients with localized PCa, to asses short-term oncologic efficacy of IRE in patients with localized PCa, to asses functional outcomes after IRE.
All patients will be followed up for 1 year (each 3 months).
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Being tested
- Focal irreversible electroporation of the prostate cancer
- Keywords
- Prostate, 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.
Focal irreversible electroporation of the prostate cancerDevice
Irreversible electroporation is a non-thermal tissue ablation technique in which short duration electrical fields are used to permanently permeabilize the cell membrane.
| Study group | Role | What they receive |
|---|---|---|
| IRE patients | Experimental | patients who will underwent 'Focal irreversible electroporation of the prostate cancer' Receives: Device: Focal irreversible electroporation of the prostate cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA level
Stable decrese of PSA level after surgery (<1 ng/ml)
Measured: 3 months, 6 months, 9 months, 12 months.
Complications
Short and long term surgical complications
Measured: 1 year
Secondary outcomes (4)
IPSS (International Prostate Symptom Score, range from 5 to 30)
International Prostate Symptom Score
Measured: 1 year
QoL (Quality of Life score, range 1-6)
Quality of Life Score
Measured: 1 year
Qmax
Maximal urine flow rate
Measured: 1 year
IIEF
International Index of Erectile Function - Erectile function assessment (range 1-5)
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 posted20 Apr 2018
- Study start19 Apr 2018
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University
- Investigators
- Dmitry Enikeev, MD, PhD, Study director, I.M. Sechenov First Moscow State Medcal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504995
- Sponsor's protocol ID
- Sechenov-IRE18
- Status last verified
- Jul 2020
- First submitted
- 12 Apr 2018
- Last updated
- 28 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Rubinsky B. Irreversible electroporation in medicine. Technol Cancer Res Treat. 2007 Aug;6(4):255-60. doi: 10.1177/153303460700600401.
PubMed 17668932Scheltema MJ, Chang JI, Bohm M, van den Bos W, Blazevski A, Gielchinsky I, Kalsbeek AMF, van Leeuwen PJ, Nguyen TV, de Reijke TM, Siriwardana AR, Thompson JE, de la Rosette JJ, Stricker PD. Pair-matched patient-reported quality of life and early oncological control following focal irreversible electroporation versus robot-assisted radical prostatectomy. World J Urol. 2018 Sep;36(9):1383-1389. doi: 10.1007/s00345-018-2281-z. Epub 2018 Mar 28.
PubMed 29594551
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Assessment of Nanoknife (AngyoDynamics, USA) for Irreversible Electroporation (IRE) of Localized Prostate Cancer.
- ClinicalTrials.gov ID
- NCT03504995
- Acronym / sponsor ID
- Sechenov-IRE18
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Keywords
- Prostate, Irreversible Electroporation, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 20 Apr 2018 (actual)
- 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.
The purpose of this study is to evaluate safety and short-term oncological efficacy of the NanoKnife Irreversible Electroporation System for localised prostate cancer.
Irreversible electroporation (IRE) is the method of focal treatment for prostate cancer, which is already proven by FDA as method of the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.
Detailed description
Irreversible electroporation is a newly developed non-thermal tissue ablation technique in which short duration electrical fields are used to form permanent nanoscale defects in the cell membrane which leads to cell apoptosis. Thus, IRE is a non-thermal technique, which means that changes associated with tissue freezing or heating are not relevant.
Moreover, animal studies of IRE in the canine prostate have demonstrated that structures such as ejaculatory ducts, neurovascular bundles, blood vessels, and the urethra heal normally after ablation. The reason is that collagen matrix during treatment with IRE is not destroyed thus allowing for a large structures (blood vessels, nerves, etc.) to heal normally.
This study is a prospective and non-randomized with one group of 10 patients eligible for focal therapy of prostate cancer with IRE (eligibility defined by this protocol).
Before the surgery all patients will underwent transperineal MRI-fusion biopsy to localize the prostate cancer foci.
Objectives of the study: to asses safety of IRE in patients with localized PCa, to asses short-term oncologic efficacy of IRE in patients with localized PCa, to asses functional outcomes after IRE.
All patients will be followed up for 1 year (each 3 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IRE patients | Experimental | Device: Focal irreversible electroporation of the prostate cancerpatients who will underwent 'Focal irreversible electroporation of the prostate cancer' |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Verified with MR-fusion biopsy localized Pca
- PSA < 15 ng/ml
- Gleason score 3+3=6; 3+4=7 OR Grade Group 1 and 2
- Life expectancy > 10 years
- No post-void residual urine or infravesical obstruction
Key exclusion criteria (10 listed)
- patients with artificial cardiac pacemaker
- patients without rectum
- patients not eligible for general anesthesia
- PIRADS<3
- patients after primary Pca treatment
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 |
|---|---|---|
| Focal irreversible electroporation of the prostate cancerIrreversible electroporation is a non-thermal tissue ablation technique in which short duration electrical fields are used to permanently permeabilize the cell membrane. | Device | IRE patients |
Primary outcome
PSA level
Time frame: 3 months, 6 months, 9 months, 12 months.
Stable decrese of PSA level after surgery (<1 ng/ml)
Complications
Time frame: 1 year
Short and long term surgical complications
4 secondary outcomes
IPSS (International Prostate Symptom Score, range from 5 to 30)
Time frame: 1 year
QoL (Quality of Life score, range 1-6)
Time frame: 1 year
Qmax
Time frame: 1 year
IIEF
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 28 Jul 2020.
- Background: PubMed 17668932Rubinsky B. Irreversible electroporation in medicine. Technol Cancer Res Treat. 2007 Aug;6(4):255-60. doi: 10.1177/153303460700600401.
- Background: PubMed 29594551Scheltema MJ, Chang JI, Bohm M, van den Bos W, Blazevski A, Gielchinsky I, Kalsbeek AMF, van Leeuwen PJ, Nguyen TV, de Reijke TM, Siriwardana AR, Thompson JE, de la Rosette JJ, Stricker PD. Pair-matched patient-reported quality of life and early oncological control following focal irreversible electroporation versus robot-assisted radical prostatectomy. World J Urol. 2018 Sep;36(9):1383-1389. doi: 10.1007/s00345-018-2281-z. Epub 2018 Mar 28.
- Individual participant dataSharing planned: Undecided
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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.
Dmitry Enikeev, MD, PhD study director
I.M. Sechenov First Moscow State Medcal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal irreversible electroporation of the prostate cancer in people with Prostate Cancer and Prostate Adenocarcinoma, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 10 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 28 Jul 2020. 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 Russia. 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.
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?
PSA level (time frame: 3 months, 6 months, 9 months, 12 months.). 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 NCT03504995, 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 28 Jul 2020.