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Prostate Radiofrequency Focal Ablation (ProRAFT) Trial: A Prospective Development Study Evaluating a Bipolar Radiofrequency Device to Treat Prostate Cancer

Orczyk, C; Barratt, D; Brew-Graves, C; Peng Hu, Y; Freeman, A; McCartan, N; Potyka, I; ... Ahmed, HU; + view all (2020) Prostate Radiofrequency Focal Ablation (ProRAFT) Trial: A Prospective Development Study Evaluating a Bipolar Radiofrequency Device to Treat Prostate Cancer. Journal of Urology 10.1097/JU.0000000000001567. (In press).

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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 4 mm 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 nonrigid 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 7.9 ng/ml (5.3-9.6), 18 (90%) had Gleason 7 with median maximum cancer of 7 mm (IQR 5-10) for a median 2.8 cc 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.

Type: Article
Title: Prostate Radiofrequency Focal Ablation (ProRAFT) Trial: A Prospective Development Study Evaluating a Bipolar Radiofrequency Device to Treat Prostate Cancer
Location: United States
DOI: 10.1097/JU.0000000000001567
Publisher version: https://doi.org/10.1097/JU.0000000000001567
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Department of Imaging
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Surgery and Interventional Sci
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Surgery and Interventional Sci > Department of Targeted Intervention
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Med Phys and Biomedical Eng
URI: https://discovery.ucl.ac.uk/id/eprint/10118255
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