This trial is active, not recruiting.

Condition prostate cancer
Treatment irreversible electroporation
Sponsor University College London Hospitals
Start date October 2013
End date August 2015
Trial size 20 participants
Trial identifier NCT01726894, 12/0399


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™).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
irreversible electroporation

Primary Outcomes

Safety Profile
time frame: Up to 1 year

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

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Histologically proven prostate cancer, Gleason Score /= 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).

Additional Information

Official title A Prospective Development Study Evaluating Focal Therapy Using Irreversible Electroporation (Nanoknife®) in Men With Localised Prostate Cancer
Principal investigator Hashim U Ahmed, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by University College London Hospitals.