Radiofrequency ablation focal treatment

Not Applicable

Completed

• Conditions: Prostate cancer; Cancer

• Registration Number: ISRCTN10434678
• Lead Sponsor: TROD Medical

Brief Summary

2018 results presented at EAU18 Copenhagen in 2018: https://doi.org/10.1016/S1569-9056(18)31378-2 (added 16/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-13
• Study Completion: 2016-11-30
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 21

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 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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)