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Focal Prostate Radiofrequency Ablation (ProRAFT)

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Coiled Bipolar Radiofrequency Ablation
Sponsored by
Trod Medical N.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Focal radiofrequency ablation, Prostate cancer, Encage

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • University College London Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ProRAFT

Arm Description

Procedure/Surgery: Coiled Bipolar Radiofrequency Ablation

Outcomes

Primary Outcome Measures

Cancer control outcome
To determine the ablative efficacy of focal therapy to treat localized low to intermediate risk prostate cancer using coiled bipolar radiofrequency ablation (Encage)

Secondary Outcome Measures

Full Information

First Posted
November 15, 2014
Last Updated
April 23, 2018
Sponsor
Trod Medical N.V.
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1. Study Identification

Unique Protocol Identification Number
NCT02294903
Brief Title
Focal Prostate Radiofrequency Ablation
Acronym
ProRAFT
Official Title
A Prospective Development Study Evaluating Focal Therapy Using Encage Coiled Bipolar Radiofrequency Ablation in Men With Localised Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
May 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trod Medical N.V.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Focal radiofrequency ablation, Prostate cancer, Encage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ProRAFT
Arm Type
Experimental
Arm Description
Procedure/Surgery: Coiled Bipolar Radiofrequency Ablation
Intervention Type
Procedure
Intervention Name(s)
Coiled Bipolar Radiofrequency Ablation
Intervention Description
Radiofrequency ablation by use of bipolar electrodes
Primary Outcome Measure Information:
Title
Cancer control outcome
Description
To determine the ablative efficacy of focal therapy to treat localized low to intermediate risk prostate cancer using coiled bipolar radiofrequency ablation (Encage)
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed U HASHIM, FRCS, PhD
Organizational Affiliation
UCLH NHS Foundation Trust
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mark EMBERTON, FRCS, MD
Organizational Affiliation
Division of Surgery & Interventional Science, UCL
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College London Hospitals
City
London
ZIP/Postal Code
NW1 2PS
Country
United Kingdom

12. IPD Sharing Statement

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Focal Prostate Radiofrequency Ablation

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