Orczyk, C;
Barratt, D;
Brew-Graves, C;
Peng Hu, Y;
Freeman, A;
McCartan, N;
Potyka, I;
... Ahmed, HU; + view all
(2021)
Prostate Radiofrequency Focal Ablation (ProRAFT) Trial: A Prospective Development Study Evaluating a Bipolar Radiofrequency Device to Treat Prostate Cancer.
Journal of Urology
, 205
(4)
pp. 1090-1099.
10.1097/JU.0000000000001567.
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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.
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