A prospective development study evaluating focal therapy using encage coiled bipolar radiofrequency ablation in men with localised prostate cancer

TROD Medical0 个研究点目标入组 21 人开始时间: 2015年3月13日最近更新: 2019年6月17日

适应症

试验速览

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

•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

•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)

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