Condition category
Cancer
Date applied
04/03/2015
Date assigned
13/03/2015
Last edited
07/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Hashim Ahmed

ORCID ID

Contact details

University College Hospital
235 Euston Road
London
NW12BU
United Kingdom

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 measures

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

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

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

Sponsor information

Organisation

TROD Medical

Sponsor details

360 Central Avenue - Suite 1260
St Petersburg
FL 33701
United States of America

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes