Radiofrequency ablation focal treatment
| ISRCTN | ISRCTN10434678 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10434678 |
| ClinicalTrials.gov number | NCT02294903 |
| Secondary identifying numbers | TM-105 |
- Submission date
- 04/03/2015
- Registration date
- 13/03/2015
- Last edited
- 28/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Hashim Ahmed
Scientific
Scientific
University College Hospital
235 Euston Road
London
NW12BU
United Kingdom
Study information
| Study design | Prospective development study (IDEAL Surgery Guidelines) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | A prospective development study evaluating focal therapy using encage coiled bipolar radiofrequency ablation in men with localised prostate cancer |
| Study acronym | ProRAFT |
| Study objectives | 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(s) | NRES Committee London - Riverside |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 13/03/2015 |
| Completion date | 30/11/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 20 |
| Total final enrolment | 21 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 13/03/2015 |
| Date of final enrolment | 31/03/2016 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
NHS GP practices in the UK
-
United Kingdom
United Kingdom
Sponsor information
TROD Medical
Industry
Industry
360 Central Avenue - Suite 1260
St Petersburg
FL 33701
United States of America
Funders
Funder type
Industry
TROD Medical (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | results presented at EAU18 Copenhagen in : | 01/03/2018 | 16/04/2019 | No | No |
Editorial Notes
28/05/2019: Internal review.
16/04/2019: Publication reference and total final enrolment added.
