Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation (Nano)
This study is not yet open for participant recruitment.
Verified November 2012 by University College London Hospitals
Sponsor:
University College London Hospitals
Information provided by (Responsible Party):
Professor Mark Emberton, University College London Hospitals
ClinicalTrials.gov Identifier:
NCT01726894
First received: October 30, 2012
Last updated: November 11, 2012
Last verified: November 2012
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Purpose
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™).
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Device: Irreversible Electroporation |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | A Prospective Development Study Evaluating Focal Therapy Using Irreversible Electroporation (Nanoknife®) in Men With Localised Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by University College London Hospitals:
Primary Outcome Measures:
- Safety Profile [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]Number of patients with adverse events using the National Cancer Institute Common Terminology Criteria (NCI CTC) classification system.
Secondary Outcome Measures:
- Sexual Side Effects [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]• Change in erectile function measured by the IIEF-15 questionnaire
- Continence side effect [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]• Number of patients with urinary incontinence as determined by the UCLA-EPIC urinary continence questionnaire
- Rectal side effects [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]• Number of patients with grade I-II-III type rectal toxicity
- Cancer Control [ Time Frame: Six months ] [ Designated as safety issue: No ]Number of patients having residual prostate cancer at 6 months biopsy
Other Outcome Measures:
- Role of follow-up MRI [ Time Frame: Six months ] [ Designated as safety issue: No ]• Assessment of postoperative MRI value in predicting residual prostate cancer using biopsy as a reference test
- Anxiety [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]• Change in anxiety levels as measured by significant change in the Memorial Anxiety Scale for Prostate Cancer
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2013 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Irreversible Electroporation | Device: Irreversible Electroporation |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726894
Contacts
| Contact: Massimo Valerio, MD | 0044(0)7449854071 | massimo.valerio@chuv.ch |
Locations
| United Kingdom | |
| University College London Hospitals | Not yet recruiting |
| London, United Kingdom, NW1 2PG | |
Sponsors and Collaborators
University College London Hospitals
Investigators
| Principal Investigator: | Hashim U Ahmed, PhD | UCLH |
| Principal Investigator: | Mark Emberton, Professor | UCLH |
More Information
No publications provided
| Responsible Party: | Professor Mark Emberton, Professor, University College London Hospitals |
| ClinicalTrials.gov Identifier: | NCT01726894 History of Changes |
| Other Study ID Numbers: | 12/0399 |
| Study First Received: | October 30, 2012 |
| Last Updated: | November 11, 2012 |
| Health Authority: | United Kingdom: National Health Service |
Keywords provided by University College London Hospitals:
|
Focal Therapy |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013