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Feasibility and safety of focal irreversible electroporation as salvage treatment for localized radio‐recurrent prostate cancer
Author(s) -
Scheltema Matthijs J.,
Bos Willemien,
Siriwardana Amila R.,
Kalsbeek Anton M.F.,
Thompson James E.,
Ting Francis,
Böhm Maret,
Haynes AnneMaree,
Shnier Ron,
Delprado Warick,
Stricker Phillip D.
Publication year - 2017
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/bju.13991
Subject(s) - medicine , common terminology criteria for adverse events , prostate cancer , adverse effect , quality of life (healthcare) , irreversible electroporation , cancer , oncology , surgery , biochemistry , chemistry , nursing , electroporation , gene
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 ( PC a). Patients and Methods Patients with localized, radio‐recurrent PC a without evidence of metastatic or nodal disease were offered focal IRE according to the consensus guidelines. Patients with a minimum follow‐up of 6 months were eligible for analysis. Adverse events were monitored using the National Cancer Institute Common Terminology Criteria for Adverse Events ( CTCAE version 4.0). Patient‐reported QoL data were collected at baseline, 6 weeks, 3, 6 and 12 months using the Expanded Prostate Cancer Index Composite ( EPIC ), the American Urological Association ( AUA ) symptom score and the 12‐item short‐from health survey ( SF ‐12) physical and mental component summary questionnaires. Oncological control was evaluated according to serial prostate‐specific antigen ( PSA ), 6‐month multiparametric magnetic resonance imaging (mp MRI ) and 12‐month 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 in the analysis. The median follow‐up was 21 months. No high‐grade adverse events ( CTCAE >2) or recto‐urethral fistulae occurred. No statistically significant declines were observed in QoL outcomes ( n = 11) on the EPIC bowel domain ( P = 0.29), AUA symptom score ( P = 0.77), or the SF ‐12 physical ( P = 0.17) or SF ‐12 mental component summary ( P = 0.77) questionnaires. At 6 months, patients who had undergone salvage therapy experienced a decline in EPIC sexual domain score (median of 38–24; P = 0.028) and urinary domain (median of 96–92; P = 0.074). Pad‐free continence and erections sufficient for intercourse were preserved in 8/11 patients and 2/6 patients at 6 months, respectively. The mp MRI was clear in 11/13 patients, with two single out‐field lesions (true‐positive and false‐positive, respectively). The median (interquartile range) nadir PSA was 0.39 (0.04–0.43) μg/L. Three and four patients experienced biochemical failure using the Phoenix and Stuttgart definitions of biochemical failure, respectively. Eight out of 10 of the patients were clear of any PC a on follow‐up biopsy, whereas two patients had significant PC a on follow‐up biopsy (International Society of Urological Pathology grade 5). Conclusion Our short‐term safety, QoL and oncological control data show that focal IRE is a feasible salvage option for localized radio‐recurrent PC a. A prospective multicentre study ( FIRE trial) has been initiated that will provide further insight into the ability of focal IRE to obtain oncological control of radio‐recurrent PC a with acceptable patient morbidity.