我需要一篇文章10.1097/JU.0000000000001567文献

　　您好，根据您的需要，我们查找到DOI:10.1097/JU.0000000000001567的外文文献，文献标题为《Prostate Radiofrequency Focal Ablation （ProRAFT） Trial: A Prospective Development Study Evaluating a Bipolar Radiofrequency Device to Treat Prostate Cancer》，下面是论文部分内容展示，查看全文请到文末自行下载！

Prostate Radiofrequency Focal Ablation （ProRAFT） trial: a prospective development study evaluating a bipolar radiofrequency device to treat prostate cancer
Clement Orczyk [1,2], Dean Barratt [3], Chris Brew-Graves [4], Yi Peng HU[3], Alex Freeman [5],Neil McCartan [1], Ingrid Potyka [1], Navin Ramachandran [7], Rachael Rodell [8], Norman R.Williams[1], Mark Emberton[1,2] *, Hashim U. Ahmed [9,6,1] *

* Joint senior authors

　　Affiliations

　　1. Division of Surgery and Interventional Sciences, University College London, London, UK

　　2. Department of Urology, UCLH NHS Foundation Trust, London, UK

　　3. Centre for Medical Image Computing （CMIC）， University College London, London, UK

　　4. Centre for Medical Imaging, Division of Medicine, Faculty of Medicine, University College London, UK

　　5. Department of Histopathology, UCLH NHS Foundation Trust, London, UK

　　6. Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine,Imperial College London, London, UK

　　7. Department of Radiology, UCLH NHS Foundation Trust, London, UK

　　8. SmartTarget Ltd, London, UK

　　9. Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London; UK

　　Address for correspondence:

　　Mr Clement Orczyk, MD PhD DESC（Urol） FRCS MPH

　　Associate Professor of Urology, Honorary Consultant Urological Surgeon

　　Division of Surgery and Interventional Science

　　University College London

　　Charles Bell House

　　43-45 Foley Street

　　London

　　W1W 7TS

　　c.orczyk@ucl.ac.uk

　　Abstract:

　　Purpose

　　To determine early efficacy of bipolar radiofrequency ablation with a coil design （bRFA） for focal ablation of clinically significant localised prostate cancer （sPCa）visible at mpMRI.

　　Material and methods

　　A prospective IDEAL phase 2 development study （NCT02294903） recruited treatment naive patients with a single focus of localised sPCa （Gleason 7 or 4mm or more of Gleason 6） concordant with a lesion visible on multi-parametric MRI. Intervention was a focal ablation with a bRFA system （Encage, Trod Medical） encompassing the lesion and a predefined margin using non-rigid MRI-ultrasound fusion. Primary outcome was the proportion of men with absence of sPCa on biopsy at 6 months. Trial follow up comprised serum PSA, mpMRI at 1 week, 6 and 12 months post ablation.

　　Validated patient reported outcome measures （PROMs） for urinary, erectile and bowel functions and adverse events monitoring system were used. Analyses were done on a per-protocol basis.

　　Results

　　20 of 21 patients recruited received the intervention. Baseline characteristics were a median age of 66 years （IQR 63-69）， pre-operative median PSA of 7.9ng/ml （5.3-9.6）， 18 （90%） had Gleason 7 with median maximum cancer of 7mm （IQR 5-10） for a median 2.8cc mpMRI lesions （IQR 1.4-4.8）。

　　Targeted biopsy of the treated area （median number of cores = 6, IQR 5-8 ）showed absence of sPCa in 16/20 men （80%）， concordant with mpMRI. There was a low profile of side effects at PROMs analysis and no serious adverse events.

　　Conclusions

　　Focal therapy of sPCa associated with an MRI lesion using bRFA showed early efficacy to ablate cancer with low rates of genitourinary and rectal side-effects.

　　Funding

　　The study was funded through a commercial grant awarded to UCL by Trod Medical.

　　Clement Orczyk received a grant from the European Association of Urology （EUSP Scholarship）

　　Please cite this article as: Orczyk C, Barratt D, Brew-Graves C, HU YP, Freeman A, McCartan N, Potyka I, Ramachandran N, Rodell R, Williams NR, Emberton M, Ahmed HU, Prostate Radiofrequency Focal Ablation （ProRAFT） trial: a prospective development study evaluating a bipolar radiofrequency device to treat prostate cancer, The Journal of Urology? （2019）， doi: 10.1097/JU.0000000000001567.

……

　　DISCLAIMER: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our subscribers we are providing this early version of the article. The paper will be copy edited and typeset, and proof will be reviewed before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to The Journal pertain.