Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT02294903
Protocol/serial number
TM-105
Study information
Scientific title
A prospective development study evaluating focal therapy using encage coiled bipolar radiofrequency ablation in men with localised prostate cancer
Acronym
ProRAFT
Study hypothesis
For men with localised prostate cancer when treating only the areas of cancer with a coiled radiofrequency based bipolar device, this can lead to a more precise and better controlled ablation minimising side effects.
Ethics approval
NRES Committee London - Riverside
Study design
Prospective development study (IDEAL Surgery Guidelines)
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
Prostate cancer
Intervention
Coiled bipolar radiofrequency ablation for men with histologically proven localized prostate cancer which is clinically significant. Localization and characterization of the disease will be established using multi-parametric (mp)-MRI and transperineal prostate biopsies. Pre-operative and all post operative imaging will be performed using a scanner and a pelvic phased array receiver, with a pelvic coil. 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. The evaluation will be done 6 months later by determining the ablative efficacy of focal therapy to treat localized low to intermediate risk prostate cancer.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Ablative efficacy of focal therapy to treat localised low to intermediate risk prostate cancer using Coiled Bipolar Radiofrequency Ablation (Encage™), using histological outcomes (Disease control: 6 months histology treated area - Proportion of men with clinically significant prostate cancer on targeted transperineal biopsy in the treated area)
Secondary outcome measures
1. Rate of any prostate cancer on targeted transperineal biopsy in the treated area
2. Rate of achievement of trifecta status (no severe Erectile Dysfunction (ED), pad-free leak-free continence, cancer control with no evidence of clinically significant cancer in treated area) at 6 months in those men with good baseline function
3. Rate of achievement of trifecta status (no severe Erectile Dysfunction (ED), pad-free continence, cancer control with no evidence of clinically significant cancer in treated area) at 6 months in those men with good baseline function
4. Time to initiation of secondary prostate cancer intervention (prostatectomy, radiotherapy, androgen ablation, focal/whole gland High Intensity Focused Ultrasound (HIFU) or cryosurgery) as a result of:
4.1. Histological burden greater than Gleason pattern 3 and/or max Cancer Core Length Involvement (CCLI) >/=3mm
4.2. Rising Prostate Specific Antigen (PSA) (needs Trial Steering Committee validation of clinical, pathological and case report form review to verify reason)
5. Time to initiation of secondary prostate cancer intervention (prostatectomy, radiotherapy, androgen ablation,focal/whole gland High Intensity Focused Ultrasound (HIFU) or cryosurgery) for any cause
Overall trial start date
13/03/2015
Overall trial end date
30/11/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically proven prostate cancer
2. A visible lesion on mpMRI, that is accessible to a treatment based on radiofrequency bipolar electrodes
3. Transperineal prostate biopsies (template mapping and/or targeted)correlating with clinically significant lesion in the area of the MR-visible lesion
4. Absence of clinically significant histological disease outside of the planned treatment zone
5. Radiological stage T1-T3 a N0 M0 disease, as determined by local guidelines
6. Serum PSA </=15ng/ml within 3 months of screening visit
7. Life expectancy of more than 10 years
8. Signed informed consent by patient
9. An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
20
Total final enrolment
21
Participant exclusion criteria
1. Men who have had previous radiation therapy to the pelvis
2. Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer
3. Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
4. Men with a tumour not visible on mpMRI
5. Men with an inability to tolerate a transrectal ultrasound
6. Men allergic to latex
7. Men who have undergone prior significant rectal surgery preventing insertion of the TRUS probe (decided on the type of surgery in individualcases)
8. Men who have had previous electroporation, radiofrequency ablation, HIFU,cryosurgery, thermal or microwave therapy to the prostate
9. Men who have undergone a Transurethral Resection of the Prostate(TURP) for symptomatic lower urinary tract symptoms within the prior 6months. These patients may be included within the trial if deferred fromconsent and screening until at least 6 months following the TURP
10. Men not fit for major surgery as assessed by a Consultant Anaesthetist
11. Men unable to have pelvic MRI scanning (severe claustrophobia,permanent cardiac pacemaker, metallic implant etc likely to contribute significant artefact to images)
12. Presence of metal implants/stents in the urethra
13. Men with renal impairment with a GFR of <35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI)
Recruitment start date
13/03/2015
Recruitment end date
31/03/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
NHS GP practices in the UK
-
United Kingdom
Funders
Funder type
Industry
Funder name
TROD Medical (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2018 results presented at EAU18 Copenhagen in 2018: https://doi.org/10.1016/S1569-9056(18)31378-2 (added 16/04/2019)