- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01726894
Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation (Nano)
June 17, 2014 updated by: Professor Mark Emberton, University College London Hospitals
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™).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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London, United Kingdom, NW1 2PG
- University College London Hospitals
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Irreversible Electroporation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual Side Effects
Time Frame: Up to 1 year
|
• Change in erectile function measured by the IIEF-15 questionnaire
|
Up to 1 year
|
Continence side effect
Time Frame: Up to 1 year
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• Number of patients with urinary incontinence as determined by the UCLA-EPIC urinary continence questionnaire
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Up to 1 year
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Rectal side effects
Time Frame: Up to 1 year
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• Number of patients with grade I-II-III type rectal toxicity
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Up to 1 year
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Cancer Control
Time Frame: Six months
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Number of patients having residual prostate cancer at 6 months biopsy
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Six months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Role of follow-up MRI
Time Frame: Six months
|
• Assessment of postoperative MRI value in predicting residual prostate cancer using biopsy as a reference test
|
Six months
|
Anxiety
Time Frame: Up to 1 year
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• Change in anxiety levels as measured by significant change in the Memorial Anxiety Scale for Prostate Cancer
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Up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hashim U Ahmed, PhD, UCLH
- Principal Investigator: Mark Emberton, Professor, UCLH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Anticipated)
August 1, 2015
Study Registration Dates
First Submitted
October 30, 2012
First Submitted That Met QC Criteria
November 11, 2012
First Posted (Estimate)
November 15, 2012
Study Record Updates
Last Update Posted (Estimate)
June 18, 2014
Last Update Submitted That Met QC Criteria
June 17, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12/0399
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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