TY - JOUR
T1 - Salvage irreversible electroporation for radio-recurrent prostate cancer – the prospective FIRE trial
AU - Blazevski, Alexandar
AU - Geboers, Bart
AU - Scheltema, Matthijs J.
AU - Gondoputro, William
AU - Doan, Paul
AU - Katelaris, Athos
AU - Agrawal, Shikha
AU - Baretto, Daniela
AU - Matthews, Jayne
AU - Haynes, Anne-Maree
AU - Delprado, Warick
AU - Shnier, Ron
AU - van den Bos, Willemien
AU - Thompson, James E.
AU - Lawrentschuk, Nathan
AU - Stricker, Phillip D.
N1 - Funding Information: Cancer Institute NSW Grant, Ramsay Foundation, St Vincent's Prostate Cancer Centre, Angio Dynamics. The authors acknowledge Cancer Institute NSW Grant, Ramsay Foundation, St Vincent's Prostate Cancer Centre for funding support, Shikha Agrawal-Clinical Research Coordinator, IT Applications Group and CANSTO Database at Garvan Institute. Funding Information: Phillip Stricker is a paid consultant with AngioDynamics. Matthijs Scheltema received educational grant from AngioDynamics. Bart Geboers received research funding from AngioDynamics. All other authors have no interests to declare. Funding Information: The authors acknowledge Cancer Institute NSW Grant, Ramsay Foundation, St Vincent's Prostate Cancer Centre for funding support, Shikha Agrawal‐Clinical Research Coordinator, IT Applications Group and CANSTO Database at Garvan Institute. Publisher Copyright: © 2022 BJU International.
PY - 2023/6
Y1 - 2023/6
N2 - Objectives: To prospectively assess the safety, functional- and oncological-outcomes of irreversible electroporation (IRE) as salvage therapy for radio-recurrent focal prostate cancer in a multicenter setting. Patients and methods: Men with focal recurrent PCa after external beam radiation or brachytherapy without metastatic disease on staging imaging and co-registration between mpMRI and biopsies were prospectively included in this multicenter trial. Adverse events were reported following the Clavien-Dindo classification. Validated questionnaires were used for patient-reported functional outcomes. Follow-up consisted of 3 monthly prostate specific antigen (PSA) levels, a 6-month mpMRI and standardised transperineal template mapping biopsies at 12-months. Thereafter follow-up was guided by MRI and/or PSMA-PET/CT and PSA. Local recurrence was defined as any ISUP score ≥2 on biopsies. Results: 37 patients were analysed with a median (interquartile range (IQR)) follow up of 29 (22–43) months. Median age was 71 (53–83), median PSA was 3.5 ng/mL (2.7–6.1). 28 (75.5%) patients harboured intermediate risk and 9 patients (24.5%) high risk PCa. Seven patients (19%) reported self-limiting urgency, frequency, or hematuria (grade 1–2). Seven patients (19%) developed a grade 3 AE; urethral sludge requiring transurethral resection. At 12 months post treatment 93% of patients remained continent and erectile function sufficient for intercourse deteriorated from 35% to 15% (4/27). Local control was achieved in 29 patients (78%) and 27 patients (73%) were clear of local and systemic disease. Four (11%) patients had local recurrence only. Six (16%) patients developed metastatic disease with a median time to metastasis of 8 months. Conclusion: The FIRE trial shows that salvage IRE after failed radiation therapy for localised PCa is safe with minimal toxicity, and promising functional and oncological outcomes. Salvage IRE can offer a possible solution for notoriously difficult to manage radio recurrent prostate tumours.
AB - Objectives: To prospectively assess the safety, functional- and oncological-outcomes of irreversible electroporation (IRE) as salvage therapy for radio-recurrent focal prostate cancer in a multicenter setting. Patients and methods: Men with focal recurrent PCa after external beam radiation or brachytherapy without metastatic disease on staging imaging and co-registration between mpMRI and biopsies were prospectively included in this multicenter trial. Adverse events were reported following the Clavien-Dindo classification. Validated questionnaires were used for patient-reported functional outcomes. Follow-up consisted of 3 monthly prostate specific antigen (PSA) levels, a 6-month mpMRI and standardised transperineal template mapping biopsies at 12-months. Thereafter follow-up was guided by MRI and/or PSMA-PET/CT and PSA. Local recurrence was defined as any ISUP score ≥2 on biopsies. Results: 37 patients were analysed with a median (interquartile range (IQR)) follow up of 29 (22–43) months. Median age was 71 (53–83), median PSA was 3.5 ng/mL (2.7–6.1). 28 (75.5%) patients harboured intermediate risk and 9 patients (24.5%) high risk PCa. Seven patients (19%) reported self-limiting urgency, frequency, or hematuria (grade 1–2). Seven patients (19%) developed a grade 3 AE; urethral sludge requiring transurethral resection. At 12 months post treatment 93% of patients remained continent and erectile function sufficient for intercourse deteriorated from 35% to 15% (4/27). Local control was achieved in 29 patients (78%) and 27 patients (73%) were clear of local and systemic disease. Four (11%) patients had local recurrence only. Six (16%) patients developed metastatic disease with a median time to metastasis of 8 months. Conclusion: The FIRE trial shows that salvage IRE after failed radiation therapy for localised PCa is safe with minimal toxicity, and promising functional and oncological outcomes. Salvage IRE can offer a possible solution for notoriously difficult to manage radio recurrent prostate tumours.
KW - Irreversible electroporation
KW - Localised prostate cancer
KW - ablation
KW - focal therapy
KW - radiation failure
KW - salvage treatment
UR - http://www.scopus.com/inward/record.url?scp=85145548105&partnerID=8YFLogxK
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85145548105&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/36495482
U2 - https://doi.org/10.1111/bju.15947
DO - https://doi.org/10.1111/bju.15947
M3 - Article
C2 - 36495482
SN - 1464-4096
VL - 131
SP - 23
EP - 31
JO - BJU international
JF - BJU international
IS - S4
ER -