Focal Prostate Radiofrequency Ablation (ProRAFT)

April 23, 2018 updated by: Trod Medical N.V.

A Prospective Development Study Evaluating Focal Therapy Using Encage Coiled Bipolar Radiofrequency Ablation in Men With Localised Prostate Cancer

To assess the early histological outcomes of tissue ablation, adverse events and genitourinary side-effect profile of focal radiofrequency ablation using a coiled bipolar device to treat localized prostate cancer in men with clinically significant prostate cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study aims to assess the ability of focal therapy using coiled bipolar radiofrequency device to ablate a pre-defined target tissue zone as well as assess side-effects. The medical device has a coiled configuration and creates thus a "Faraday cage" effect, preventing surrounding tissue damage and the bipolar configuration produces complete tissue thermo coagulation within the limits the coil.

Thereof it is proposed to conduct a prospective development study, offering focal therapy coiled bipolar radiofrequency ablation to men with histologically proven localized prostate cancer which is clinically significant.

Localization and characterization of the disease will be established using multi-parametric magnetic resonance imaging (mp-MRI) and transperineal prostate biopsies. Magnetic resonance (MR)-visible, clinically significant disease will be targeted and focally treated with a margin of normal tissue as big as anatomically possible to obtain an adequate margin of normal tissue around the lesion for effective ablation. Secondary lesions meeting criteria for clinical insignificance will be left untreated and undergo surveillance.

Pre-operative and all post operative imaging will be performed using a scanner and a pelvic phased array receiver, with a pelvic coil. A full protocol of T1 and T2 weighted turbo-spin echo images and a dynamic post gadolinium volume acquisition will be used for both pre-operative diagnostic and planning scans and post-operative assessment by use of the medical device.

The initial transperineal biopsy will already have been performed, prior to invitation to participate in the study, and demonstrating eligibility for inclusion.

The process will involve targeted or mapping biopsies which are concordant with the lesion seen on MRI. In both cases, transperineal biopsies will be taken from the prostate using a brachytherapy grid placed over the perineal skin whilst the man is in the lithotomy position.

They will be given as much time as they need to consider whether or not patients wish to participate. The ones who wish to participate after reading the patient information sheet will undergo a screening visit (first visit) to ascertain whether or not they are eligible for the trial. If so, they will proceed to focal radiofrequency ablation using a coiled bipolar device(second visit), and will be seen at further follow-up visits.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, NW1 2PS
        • University College London Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Histologically proven prostate cancer
  • A visible lesion on multiparametric Magnetic Resonance Imaging (mpMRI), that is accessible to a treatment based on radiofrequency bipolar electrodes
  • Transperineal prostate biopsies (template mapping and/or targeted) correlating with clinically significant lesion in the area of the Magnetic Resonance (MR)-visible lesion
  • Absence of clinically significant histological disease outside of the planned treatment zone
  • Radiological stage T1-T3aN0M0 disease, as determined by local guidelines
  • Serum prostate-specific antigen (serum PSA) </=15ng/ml within 3 months of screening visit
  • Life expectancy of more than 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 to the pelvis
  • 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 tumour not visible on mpMRI
  • Men with an inability to tolerate a transrectal ultrasound (TRUS)
  • Men allergic to latex
  • Men who have undergone prior significant rectal surgery preventing insertion of the transrectal ultrasound probe (decided on the type of surgery in individual cases)
  • Men who have had previous electroporation, radiofrequency ablation, High Intensity Focused Ultrasound (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 the prior 6 months. These patients may be included within the trial if deferred from consent 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 Glomerular Filtration Rate (GFR) of <35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ProRAFT
Procedure/Surgery: Coiled Bipolar Radiofrequency Ablation
Procedure: Coiled Bipolar Radiofrequency Ablation
Radiofrequency ablation by use of bipolar electrodes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer control outcome
Time Frame: 6 months
To determine the ablative efficacy of focal therapy to treat localized low to intermediate risk prostate cancer using coiled bipolar radiofrequency ablation (Encage)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trod Medical N.V.

Investigators

  • Study Chair: Ahmed U HASHIM, FRCS, PhD, UCLH NHS foundation trust
  • Principal Investigator: Mark EMBERTON, FRCS, MD, Division of Surgery & Interventional Science, UCL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2015

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ANTICIPATED)

May 30, 2018

Study Registration Dates

First Submitted

November 15, 2014

First Submitted That Met QC Criteria

November 18, 2014

First Posted (ESTIMATE)

November 19, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 24, 2018

Last Update Submitted That Met QC Criteria

April 23, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TM-105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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