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Focal Prostate Radiofrequency Ablation (ProRAFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02294903
Recruitment Status : Unknown
Verified April 2018 by Trod Medical N.V..
Recruitment status was:  Active, not recruiting
First Posted : November 19, 2014
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Trod Medical N.V.

Tracking Information
First Submitted Date  ICMJE November 15, 2014
First Posted Date  ICMJE November 19, 2014
Last Update Posted Date April 24, 2018
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2014)		 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Focal Prostate Radiofrequency Ablation
Official Title  ICMJE A Prospective Development Study Evaluating Focal Therapy Using Encage Coiled Bipolar Radiofrequency Ablation in Men With Localised Prostate Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Procedure: Coiled Bipolar Radiofrequency Ablation
Radiofrequency ablation by use of bipolar electrodes
Study Arms  ICMJE Experimental: ProRAFT
Procedure/Surgery: Coiled Bipolar Radiofrequency Ablation
Intervention: Procedure: Coiled Bipolar Radiofrequency Ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 18, 2014)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02294903
Other Study ID Numbers  ICMJE TM-105
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Trod Medical N.V.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Trod Medical N.V.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ahmed U HASHIM, FRCS, PhD UCLH NHS Foundation Trust
Principal Investigator: Mark EMBERTON, FRCS, MD Division of Surgery & Interventional Science, UCL
PRS Account Trod Medical N.V.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP