Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation (Nano)
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ClinicalTrials.gov Identifier: NCT01726894
Verified June 2014 by Professor Mark Emberton, University College London Hospitals. Recruitment status was: Active, not recruiting
: November 15, 2012
Last Update Posted
: June 18, 2014
University College London Hospitals
Information provided by (Responsible Party):
Professor Mark Emberton, University College London Hospitals
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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
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).