3 years ago

Feasibility and safety of focal irreversible electroporation as salvage treatment for localized radio-recurrent prostate cancer

Anne-Maree Haynes, Matthijs J. Scheltema, Francis Ting, Willemien den Bos, Warick Delprado, James E. Thompson, Maret Böhm, Anton M.F. Kalsbeek, Phillip D. Stricker, Ron Shnier, Amila R. Siriwardana
Objectives To evaluate the feasibility, safety, early quality of life (QoL) and oncological outcomes of salvage focal irreversible electroporation (IRE) for radio-recurrent prostate cancer (PCa). Patients and methods Patients with localized, radio-recurrent PCa without evidence of metastatic or nodal disease were offered focal IRE following the consensus guidelines. Patients with a minimum follow-up of 6 months were eligible for analysis. Adverse events were monitored using the NCI Common Terminology Criteria for Adverse Events (CTCAE version 4.0). Patient-reported QoL data was collected at baseline, 6 weeks, 3, 6 and 12 months using the Expanded Prostate Cancer Index Composite (EPIC), AUA symptom score and SF-12 Physical and Mental Component Summary (SF12-physical/SF12-mental) questionnaires. Oncological control was evaluated with serial prostate-specific antigen (PSA), 6-months multiparametric MRI (mpMRI) and 12-months prostate biopsy. Wilcoxon's Signed Rank Test was used to assess QoL differences over time in paired continuous variables. Results A total of 18 patients were included for analysis. The median follow-up was 21 months. No high-grade adverse events (CTCAE >2) or recto-urethral fistula occurred. There were no statistically significant declines observed in QoL outcomes (n=11) on the EPIC Bowel domain (p=0.29), AUA symptom score (p=0.77), SF12-physical (p=0.17) and SF12-mental (p=0.77) questionnaires. At 6 months salvage patients experienced a decline in EPIC sexual domain (median of 38 to 24, p=0.028) and urinary domain (median of 96 to 92, p=0.074). Pad-free continence and erections sufficient for intercourse were preserved in 73% (n=8/11) and 33% (n=2/6) at 6 months, respectively. The mpMRI was clear in 85% (n=11/13), with two single out-field lesions (true-positive and false-positive, respectively). Median nadir PSA was 0.39 μg/L (IQR 0.04-0.43). A total of 3 (17%) and 4 (22%) patients experienced biochemical failure using the Phoenix and Stuttgart definitions of biochemical failure, respectively. 80% (n=8/10) of the patients were clear of any PCa on follow-up biopsy, whereas 2 patients had significant PCa on follow-up biopsy (ISUP 5). Conclusion Our short-term safety, QoL and oncological control data demonstrate that focal IRE is a feasible salvage option for localized radio-recurrent PCa. A prospective multi-centre study (FIRE-trial) has been initiated that will provide further insight in the ability of focal IRE to obtain oncological control of radio-recurrent PCa with acceptable patient morbidity. This article is protected by copyright. All rights reserved.

Publisher URL: http://onlinelibrary.wiley.com/resolve/doi

DOI: 10.1111/bju.13991

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