Prostate Cancer
Conditions
Keywords
Focal Therapy
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™).
Interventions
DEVICEIrreversible Electroporation
Sponsors
University College London Hospitals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Sexual Side Effects | Up to 1 year | • Change in erectile function measured by the IIEF-15 questionnaire |
| 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 |
| Cancer Control | Six months | Number of patients having residual prostate cancer at 6 months biopsy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Role of follow-up MRI | Six months | • Assessment of postoperative MRI value in predicting residual prostate cancer using biopsy as a reference test |
| Anxiety | Up to 1 year | • Change in anxiety levels as measured by significant change in the Memorial Anxiety Scale for Prostate Cancer |
Countries
United Kingdom
Outcome results
None listed