Prostate CancerNanoNCT01726894
Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation
A study testing Irreversible Electroporation in people with Prostate Cancer, run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
To determine the adverse events and genito-urinary side-effect profile of focal therapy to treat localised low to intermediate risk prostate cancer using irreversible electroporation (Nanoknife™). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Irreversible Electroporation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Aug 2015
- 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
- Histologically proven prostate cancer, Gleason Score </=7
- An anterior visible lesion on mpMRI, that is accessible to IRE treatment
- Transperineal prostate biopsies (template mapping and/or limited targeted) correlating with clinically significant lesion in the area of the MR-visible lesion (within 2 Barzell zones)
- Absence of clinically significant disease outside of the planned treatment zone, from histopathology and/or mpMRI findings
- Stage radiologicalT1-T2cN0M0 disease, as determined by local guidelines
- Serum PSA </=15 ng/ml
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- Life expectancy of >/= 10 years
- Signed informed consent by patient
- An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
Who cannot join
- Men who have had previous radiation therapy
- Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer
- Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
- Men with a non-visible tumour on mpMRI
- Men with an inability to tolerate a transrectal ultrasound
- Men with latex allergies
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- Men who have undergone prior significant rectal surgery preventing insertion of the TRUS probe (decided on the type of surgery in individual cases)
- Men who have had previous IRE, HIFU, cryosurgery, thermal or microwave therapy to the prostate.
- Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within 6 months. These patients may be included within the trial if deferred from consenting and screening until at least 6 months following the TURP.
- Men not fit for major surgery as assessed by a Consultant Anaesthetist
- Men unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant etc likely to contribute significant artefact to images)
- Presence of metal implants/stents in the urethra
- Men with renal impairment with a GFR of <35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospitals
London, NW1 2PG
About this study
Official title: A Prospective Development Study Evaluating Focal Therapy Using Irreversible Electroporation (Nanoknife®) in Men With Localised Prostate Cancer
To determine the adverse events and genito-urinary side-effect profile of focal therapy to treat localised low to intermediate risk prostate cancer using irreversible electroporation (Nanoknife™).
- Conditions
- Prostate Cancer
- Being tested
- Irreversible Electroporation
- Keywords
- Focal Therapy
- 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 ElectroporationDevice
| Study group | Role | What they receive |
|---|---|---|
| Irreversible Electroporation | Experimental | Not described Receives: Device: Irreversible Electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Profile
Number of patients with adverse events using the National Cancer Institute Common Terminology Criteria (NCI CTC) classification system.
Measured: Up to 1 year
Secondary outcomes (4)
Sexual Side Effects
- Change in erectile function measured by the IIEF-15 questionnaire
Measured: Up to 1 year
Continence side effect
- Number of patients with urinary incontinence as determined by the UCLA-EPIC urinary continence questionnaire
Measured: Up to 1 year
Rectal side effects
- Number of patients with grade I-II-III type rectal toxicity
Measured: Up to 1 year
Cancer Control
Number of patients having residual prostate cancer at 6 months biopsy
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startOct 2013
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Mark Emberton, University College London Hospitals
- Investigators
- Hashim U Ahmed, PhD, Principal investigator, University College London HospitalsMark Emberton, Professor, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726894
- Sponsor's protocol ID
- 12/0399
- Acronym
- Nano
- Status last verified
- Jun 2014
- First submitted
- 30 Oct 2012
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Development Study Evaluating Focal Therapy Using Irreversible Electroporation (Nanoknife®) in Men With Localised Prostate Cancer
- ClinicalTrials.gov ID
- NCT01726894
- Acronym / sponsor ID
- Nano / 12/0399
- Conditions
- Prostate Cancer
- Keywords
- Focal Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Aug 2015 (estimated)
- First posted
- 15 Nov 2012 (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.
To determine the adverse events and genito-urinary side-effect profile of focal therapy to treat localised low to intermediate risk prostate cancer using irreversible electroporation (Nanoknife™).
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irreversible Electroporation | Experimental | Device: Irreversible Electroporation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically proven prostate cancer, Gleason Score </=7
- An anterior visible lesion on mpMRI, that is accessible to IRE treatment
- Transperineal prostate biopsies (template mapping and/or limited targeted) correlating with clinically significant lesion in the area of the MR-visible lesion (within 2 Barzell zones)
- Absence of clinically significant disease outside of the planned treatment zone, from histopathology and/or mpMRI findings
- Stage radiologicalT1-T2cN0M0 disease, as determined by local guidelines
Key exclusion criteria (13 listed)
- Men who have had previous radiation therapy
- Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer
- Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
- Men with a non-visible tumour on mpMRI
- Men with an inability to tolerate a transrectal ultrasound
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 | Device | Irreversible Electroporation |
Primary outcome
Safety Profile
Time frame: Up to 1 year
Number of patients with adverse events using the National Cancer Institute Common Terminology Criteria (NCI CTC) classification system.
4 secondary outcomes
Sexual Side Effects
Time frame: Up to 1 year
Continence side effect
Time frame: Up to 1 year
Rectal side effects
Time frame: Up to 1 year
Cancer Control
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
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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.
Hashim U Ahmed, PhD principal investigator
University College London Hospitals
Mark Emberton, Professor principal investigator
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irreversible Electroporation in people with Prostate Cancer, run by University College London Hospitals at 1 site in United Kingdom.
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 9 inclusion and 13 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 18 Jun 2014. 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 United Kingdom. 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?
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?
Safety Profile (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2014.