Prostate CancerProRAFTNCT02294903
Focal Prostate Radiofrequency Ablation
A study testing Coiled Bipolar Radiofrequency Ablation in people with Prostate Cancer, run by Trod Medical N.V. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Coiled Bipolar Radiofrequency Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to 30 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospitals
London, NW1 2PS
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Coiled Bipolar Radiofrequency Ablation
- Keywords
- Focal radiofrequency ablation, Prostate cancer, Encage
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coiled Bipolar Radiofrequency AblationProcedure or surgery
Radiofrequency ablation by use of bipolar electrodes
| Study group | Role | What they receive |
|---|---|---|
| ProRAFT | Experimental | Procedure/Surgery: Coiled Bipolar Radiofrequency Ablation Receives: Procedure: Coiled Bipolar Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionApr 2018
- Study completion30 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trod Medical N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmed U HASHIM, FRCS, PhD, Study chair, UCLH NHS Foundation TrustMark EMBERTON, FRCS, MD, Principal investigator, Division of Surgery & Interventional Science, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294903
- Sponsor's protocol ID
- TM-105
- Acronym
- ProRAFT
- Status last verified
- Apr 2018
- First submitted
- 15 Nov 2014
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Development Study Evaluating Focal Therapy Using Encage Coiled Bipolar Radiofrequency Ablation in Men With Localised Prostate Cancer
- ClinicalTrials.gov ID
- NCT02294903
- Acronym / sponsor ID
- ProRAFT / TM-105
- Conditions
- Prostate Cancer
- Keywords
- Focal radiofrequency ablation, Prostate cancer, Encage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Trod Medical N.V.Industry (pharma, biotech, devices)
- Study start
- Mar 2015 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- 30 May 2018 (estimated)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ProRAFT | Experimental | Procedure: Coiled Bipolar Radiofrequency AblationProcedure/Surgery: Coiled Bipolar Radiofrequency Ablation |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coiled Bipolar Radiofrequency AblationRadiofrequency ablation by use of bipolar electrodes | Procedure or surgery | ProRAFT |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed U HASHIM, FRCS, PhD study chair
UCLH NHS Foundation Trust
Mark EMBERTON, FRCS, MD principal investigator
Division of Surgery & Interventional Science, UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coiled Bipolar Radiofrequency Ablation in people with Prostate Cancer, run by Trod Medical N.V. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer control outcome (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.