EAU 2018: Prostate Radio-frequency Ablation Focal Treatment - ProRAFT

Copenhagen, Denmark (UroToday.com) Radiofrequency ablation (RFA) using a bipolar coil design (Encage® device) which acts as a Faraday cage offers the versatility needed to perform focal treatment of localised prostate cancer, whilst sparing critical anatomical and functional structures. In this study the authors report final outcomes of an ethics approved prospective development study, investigating focal Encage® ablation (NCT02294903). The primary objective was to determine the ablative efficacy 6 months after bipolar RFA against histology. The secondary objectives included the assessment of genito-urinary toxicity.

A total of 21 men were included in the study. All men had:

  1. Multi-parametric MR (mpMRI)-visible significant lesion concordant with trans-perineal biopsies 
  2. Absence of clinically significant disease elsewhere
  3. PSA <=15ng/ml
All men underwent day-case bipolar RFA with >=5mm margins around the lesion, using elastic image-fusion (SmartTarget® platform). mpMRI trans-perineal targeted biopsies of the ablated zone, and any new suspicious areas, were carried out 6 months after RFA, and all men were prospectively followed for a duration of one year.

After completion of recruitment, a total of 20 treated men were included. None were eligible for active surveillance. A total of 10 lesions were anterior and 10 posterior for a median volume of 2.7 cc at mpMRI. No significant residual disease or new cancer was found in 16/20 (80%) patients at posttreatment biopsy. Out of the 4/20 (20%) men who failed treatment, two underwent retreatment and two were put on surveillance for 4mm Gleason 6 (3+3) and 1 mm of Gleason (3+4) (when pre-treatment these lesions measured 7.5 mm Gleason (3+4) and 10mm G(3+4), respectively). 

Median PSA at 12 months post RFA was 2.7 ng/mL vs 8.1ng/ml preoperatively (p<0.001). At last visit, 1 patient with apical disease, who needed urethral dilation due to a stricture showed decreased function with leakage. IPSS remained unchanged from 9.1 to 9.89 (p=0.71) and IPSS quality-of-life was unchanged as well, from 1.84 to 1.6 (p=0.6). Erectile (IIEF-15) and bowel (UCLA-EPIC) functions remained significantly stable as demonstrated by EQ-5D and the FACT-P. No serious adverse events were reported resulting from the procedure.

The authors concluded that RFA using a bipolar device (Encage®) showed promising early control of significant disease, and a low profile of genito-urinary toxicity. Further phase II multicentre trials are required before using this modality.

Presented by: Orczyk C, University College London, Division of Surgery and Interventional Sciences, London, United Kingdom

Written by: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre, twitter: @GoldbergHanan at the 2018 European Association of Urology Meeting EAU18, 16-20 March, 2018 Copenhagen, Denmark