Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation
Not Applicable
- Conditions
- Prostate Cancer
- Interventions
- Device: Irreversible Electroporation
- Registration Number
- NCT01726894
- Lead Sponsor
- University College London Hospitals
- Brief 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™).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 20
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Irreversible Electroporation Irreversible Electroporation -
- Primary Outcome Measures
Name Time Method Safety Profile Up to 1 year Number of patients with adverse events using the National Cancer Institute Common Terminology Criteria (NCI CTC) classification system.
- Secondary Outcome Measures
Name Time Method Sexual Side Effects Up to 1 year • Change in erectile function measured by the IIEF-15 questionnaire
Cancer Control Six months Number of patients having residual prostate cancer at 6 months biopsy
Continence side effect Up to 1 year • Number of patients with urinary incontinence as determined by the UCLA-EPIC urinary continence questionnaire
Rectal side effects Up to 1 year • Number of patients with grade I-II-III type rectal toxicity
Trial Locations
- Locations (1)
University College London Hospitals
🇬🇧London, United Kingdom