Focal Therapy for Localised Prostate Cancer Using Irreversible Electroporation

NCT01726894 | Unknown DMC

• 1 other identifier: 12/0399
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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™).

Conditions

Prostate Cancer

Keywords

Focal Therapy

Outcome Measures

Primary Outcomes (1)

• Safety Profile

  Number of patients with adverse events using the National Cancer Institute Common Terminology Criteria (NCI CTC) classification system.

  Up to 1 year

Secondary Outcomes (4)

• Sexual Side Effects

  Up to 1 year

• Continence side effect

  Up to 1 year

• Rectal side effects

  Up to 1 year

• Cancer Control

  Six months

Other Outcomes (2)

• Role of follow-up MRI

  Six months

• Anxiety

  Up to 1 year

Study Arms (1)

Irreversible Electroporation

EXPERIMENTAL

Device: Irreversible Electroporation

Interventions

Irreversible Electroporation DEVICE

Irreversible Electroporation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University College London Hospitals: lead

Study Sites (1)

University College London Hospitals

London, NW1 2PG, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Hashim U Ahmed, PhD

  UCLH

  PRINCIPAL INVESTIGATOR

• Mark Emberton, Professor

  UCLH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 30, 2012
• First Posted: November 15, 2012
• Study Start: October 1, 2013
• Primary Completion: August 1, 2015
• Last Updated: June 18, 2014

Record last verified: 2014-06

Locations

GB (1)