Clinical trial NCT01726894: Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation
Official title: A Prospective Development Study Evaluating Focal Therapy Using Irreversible Electroporation (Nanoknife®) in Men With Localised Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Focal Therapy
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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™).


Eligibility criteria: 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).

Primary outcomes:
measure: Safety Profile
timeFrame: Up to 1 year
Secondary outcomes:
measure: Sexual Side Effects
timeFrame: Up to 1 year
measure: Continence side effect
timeFrame: Up to 1 year
measure: Rectal side effects
timeFrame: Up to 1 year
measure: Cancer Control
timeFrame: Six months
Other outcomes:
measure: Role of follow-up MRI
timeFrame: Six months
measure: Anxiety
timeFrame: Up to 1 year
Locations:
city: London
country: United Kingdom
facility: University College London Hospitals
Study officials:
affiliation: UCLH
name: Hashim U Ahmed, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCLH
name: Mark Emberton, Professor
role: PRINCIPAL_INVESTIGATOR
References: