The SAFE Pilot Trial-SAlvage Focal Irreversible Electroporation-For Recurrent Localized Prostate Cancer: Rationale and Study Protocol.
PSMA-PET/CT
biochemical recurrence (BCR)
focal treatment
irreversible electroporation (IRE)
prostate cancer
Journal
Frontiers in surgery
ISSN: 2296-875X
Titre abrégé: Front Surg
Pays: Switzerland
ID NLM: 101645127
Informations de publication
Date de publication:
2022
2022
Historique:
received:
20
03
2022
accepted:
04
05
2022
entrez:
24
6
2022
pubmed:
25
6
2022
medline:
25
6
2022
Statut:
epublish
Résumé
Currently, the majority of prostate cancer (PCa) recurrences after non-surgical first-line treatment are managed with androgen-deprivation therapy (ADT). Salvage radical prostatectomy (sRP) is a curative alternative to ADT but yields significant morbidity. Preliminary evidence from focal salvage treatments shows similar oncological control but lower morbidity compared to sRP. Among available ablative focal energies, irreversible electroporation (IRE) is a treatment modality that proved promising, especially in treating apical lesions, where PCa most often recurs. Our aim is to test the safety of salvage IRE for recurrent PCa. We performed a single-arm pilot feasibility study (IDEAL stage 2a): SAFE, SAlvage Focal irreversible Electroporation for recurrent localized PCa. Twenty patients with biopsy-proven PCa recurrence after primary non-surgical (radiation or ablation) treatment were included. All men will undergo mpMRI ± targeted biopsies, pre-operative PSMA-PET staging before inclusion and sIRE. Outcomes will be evaluated through internationally validated questionnaires and morbidity scales. All men will undergo a control biopsy at one year. Primary objectives were the evaluation of the safety of sIRE (and patients' quality of life) after treatment. Secondary objectives were the evaluation of functional outcomes, namely, continence and erectile function changes and evaluation of short-term oncological efficacy. SAFE is the second pilot study to evaluate sIRE and the first one performed according to the most recent diagnostic and staging imaging standards. sIRE may provide a curative option for recurrent PCa together with lower comorbidities compared to sRP.
Identifiants
pubmed: 35747441
doi: 10.3389/fsurg.2022.900528
pmc: PMC9209638
doi:
Types de publication
Journal Article
Langues
eng
Pagination
900528Informations de copyright
Copyright © 2022 Marra, Shah, D'Agate, Marquis, Calleris, Lunelli, Filippini, Oderda, Gatti, Valerio, Sanchez-Salas, Bossi, Gomez Rivas, Conte, Deandreis, Cussenot, Ricardi and Gontero.
Déclaration de conflit d'intérêts
Luca Lunelli and Olivier Cussenot have worked as consultants and proctors for Angiodynamics, Latham, NY. The publication costs of this study protocol are covered by Angiodynamics, Latham, NY.
Références
Minerva Urol Nefrol. 2018 Jun;70(3):252-263
pubmed: 29664243
Hepatobiliary Surg Nutr. 2015 Jun;4(3):211-5
pubmed: 26151062
Urol Oncol. 2021 May;39(5):296.e21-296.e29
pubmed: 33436329
World J Urol. 2021 Mar;39(3):719-728
pubmed: 32529451
J Clin Med. 2021 Aug 29;10(17):
pubmed: 34501331
Eur Urol. 2021 Sep;80(3):280-292
pubmed: 33309278
Eur Urol. 2019 Jul;76(1):98-105
pubmed: 30638633
World J Urol. 2021 Apr;39(4):1107-1114
pubmed: 32488359
Lancet. 2020 Apr 11;395(10231):1208-1216
pubmed: 32209449
J Urol. 2015 Oct;194(4):977-82
pubmed: 25983194
Health Technol Assess. 2018 Sep;22(52):1-96
pubmed: 30264692
BMJ. 2013 Jun 18;346:f3011
pubmed: 23778426
JAMA Oncol. 2018 Jun 14;4(6):e180039
pubmed: 29543933
Prostate. 2018 Jul;78(10):697-706
pubmed: 29603326
Eur Urol. 2020 Apr;77(4):403-417
pubmed: 30773328
Cancers (Basel). 2018 Dec 03;10(12):
pubmed: 30513915
BJU Int. 2019 Sep;124(3):431-440
pubmed: 30753756
Urol Oncol. 2018 Dec;36(12):529.e11-529.e22
pubmed: 30301698
Eur Urol Oncol. 2019 Sep;2(5):526-538
pubmed: 31412013
JCI Insight. 2019 Jan 24;4(2):
pubmed: 30674724
Contemp Clin Trials. 2015 Sep;44:175-186
pubmed: 26184343
Lancet Oncol. 2010 Nov;11(11):1066-73
pubmed: 20933466
Curr Opin Urol. 2014 May;24(3):241-6
pubmed: 24625430
CA Cancer J Clin. 2020 Jan;70(1):7-30
pubmed: 31912902
Arch Esp Urol. 2016 Jul;69(6):271-80
pubmed: 27416630
J Clin Oncol. 2010 Dec 1;28(34):5038-45
pubmed: 21041715
Eur Urol. 2021 Dec;80(6):682-689
pubmed: 34465492
Andrologia. 2020 Nov;52(10):e13789
pubmed: 32786087
World J Urol. 2019 Aug;37(8):1469-1483
pubmed: 30955047
Eur Urol Focus. 2021 Apr 26;:
pubmed: 33926838
J Natl Cancer Inst. 2000 Nov 1;92(21):1731-9
pubmed: 11058616
Eur Urol. 2016 Jun;69(6):973-5
pubmed: 26778462
Urology. 2020 Jun;140:122-131
pubmed: 32061825
J Clin Oncol. 2010 Mar 1;28(7):1117-23
pubmed: 20124165
BJU Int. 2017 Nov;120 Suppl 3:51-58
pubmed: 28834167
Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):e787-93
pubmed: 22331003
Br J Surg. 2016 Apr;103(5):607-15
pubmed: 26865013
Eur Urol. 2011 Sep;60(3):411-2
pubmed: 21247684
Transl Androl Urol. 2020 Jun;9(3):1535-1545
pubmed: 32676441
Technol Cancer Res Treat. 2007 Aug;6(4):295-300
pubmed: 17668936
BJU Int. 2021 Jan;127(1):122-130
pubmed: 32455504
World J Urol. 2019 Aug;37(8):1517-1534
pubmed: 30710157
N Engl J Med. 2009 Oct 22;361(17):1704-6
pubmed: 19846858
J Urol. 2019 Oct;202(4):725-731
pubmed: 31075058
World J Urol. 2019 Feb;37(2):277-287
pubmed: 30610359
Eur Urol. 2018 Apr;73(4):488-490
pubmed: 28851581
Prostate Cancer Prostatic Dis. 2018 Jun;21(2):175-186
pubmed: 29743538
Urol Int. 2016;97(2):230-7
pubmed: 27256369
Int Braz J Urol. 2020 Nov-Dec;46(6):984-992
pubmed: 32822127
Eur Urol. 2012 May;61(5):961-71
pubmed: 22280856
J Clin Oncol. 1997 Jan;15(1):230-8
pubmed: 8996147
Minerva Urol Nefrol. 2016 Aug 31;69(1):26-37
pubmed: 27579821
Diagn Interv Radiol. 2018 Sep;24(5):268-275
pubmed: 30211680
Lancet Oncol. 2016 Aug;17(8):1047-1060
pubmed: 27339115