A Prospective Development Study Evaluating Focal Therapy Using Irreversible Electroporation (NanoknifeĀ®) in Men With Localised Prostate Cancer
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).