The SAFE Pilot Trial-SAlvage Focal Irreversible Electroporation-For Recurrent Localized Prostate Cancer: Rationale and Study Protocol.

Details

Serval ID
serval:BIB_861CF12CB630
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
The SAFE Pilot Trial-SAlvage Focal Irreversible Electroporation-For Recurrent Localized Prostate Cancer: Rationale and Study Protocol.
Journal
Frontiers in surgery
Author(s)
Marra G., Shah T.T., D'Agate D., Marquis A., Calleris G., Lunelli L., Filippini C., Oderda M., Gatti M., Valerio M., Sanchez-Salas R., Bossi A., Gomez-Rivas J., Conte F., Deandreis D., Cussenot O., Ricardi U., Gontero P.
ISSN
2296-875X (Print)
ISSN-L
2296-875X
Publication state
Published
Issued date
2022
Peer-reviewed
Oui
Volume
9
Pages
900528
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Abstract
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.
Keywords
PSMA-PET/CT, biochemical recurrence (BCR), focal treatment, irreversible electroporation (IRE), prostate cancer
Pubmed
Web of science
Open Access
Yes
Create date
04/07/2022 14:33
Last modification date
07/08/2022 6:36
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