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. 2022 Jun 7:9:900528.
doi: 10.3389/fsurg.2022.900528. eCollection 2022.

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

Giancarlo Marra  1   2 , Taimur T Shah  3 , Daniele D'Agate  1 , Alessandro Marquis  1 , Giorgio Calleris  1 , Luca Lunelli  2 , Claudia Filippini  1 , Marco Oderda  1 , Marco Gatti  4 , Massimo Valerio  5 , Rafael Sanchez-Salas  6 , Alberto Bossi  7 , Juan Gomez-Rivas  8 , Francesca Conte  1 , Desiree Deandreis  9 , Olivier Cussenot  2 , Umberto Ricardi  10 , Paolo Gontero  1
Affiliations

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

Giancarlo Marra et al. Front Surg. .

Abstract

Introduction: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Flowchart illustrating the different steps from patient referral to study inclusion.
Figure 2
Figure 2
Different axial representations of salvage irreversible electroporation ablation schemes used in the SAFE study. Ant, anterior prostate; U, urethra; PCa, prostate cancer focus (red); Needle, irreversible electroporation needle (gray); ablation zone is displayed in orange. (A) Overall prostate view; (B) focal ablation; (C) hemi-ablation; (D) hockey stick ablation. Quadrant ablation will also be performed (not shown in the image).
Figure 3
Figure 3
Flowchart illustrating the different steps of the study after patient inclusion. *=Clinical examination and questionnaires; at 1 week, a phone interview will be performed instead of a clinical visit; PCa, prostate cancer; IRE, irreversible electroporation; TCAE v 5.0, National Cancer Institute Common Terminology Criteria for Adverse Events; QoL, quality of life; EPIC, Expanded Prostate Cancer Index Composite—with specific urinary, sexual and bowel domains; IPSS, International Prostate Symptoms Score; IIEF-5, International Index of Erectile Function version 5.
See this image and copyright information in PMC

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