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De Luca et al. Mini-invasive Surg 2022;6:13 https://dx.doi.org/10.20517/2574-1225.2021.127 Page 7 of 8

In our series positive, SM rate was quite similar (27.2%), and in all of these cases extracapsular extension of
the disease (≥pT3) was present. Sexual function outcomes were poor also in our patients (potency rate 18%).
Although we have performed monolateral nerve-sparring surgery in 3 patients, we are convinced that
potency preservation with monoliteral/bilateral nerve-sparring should not be a realistic aim of sRARP post
HIFU for a combination of post HIFU fibrosis, cancer factors, and erectile dysfunction.

The major limitations of the present study are: the short oncological follow-up time and the retrospective
design of the study. Important limitations, which also concerned the other few studies about this topic,
include the absence of standardized criteria for focal therapy, salvage treatment, and the definition of focal
therapy failure. Finally, it is very likely that patients selected for sRARP, instead of further focal treatment or
surveillance, presented with more aggressive recurrences. As such, patients in the current study may not be
representative of all men experiencing recurrent disease after focal therapy.

However, our findings are particularly noteworthy because we reported and classified the adverse events
[24]
and the treatment impacts on patients’ quality of life, rigorously filling a gap of the current literature .
Moreover, our data, despite the limited sample size, are encouraging and confirm that overall complications
rate and urinary continence outcomes of sRARP for men experiencing disease recurrence post HIFU are
acceptable and are not much worse than those in the primary setting.

DECLARATIONS
Authors’ contributions
Conception and design: De Luca S, De Cillis S
Acquisition of data: De Cillis S, Piramide F, Alessio P, Volpi G, Granato S
Analysis and interpretation of data: De Luca S, De Cillis S, Checcucci E
Drafting of the manuscript: De Luca S, De Cillis S
Critical revision of the manuscript for important intellectual content: Porpiglia F, Fiori C, Manfredi M
Administrative, technical, or material support: Russo F
Supervision: Amparore D, Fiori C

Availability of data and materials
Not applicable.

Financial support and sponsorship
None.

Conflicts of interest
All authors declared that there are no conflicts of interest.

Ethical approval and consent to participants
This is to certify that for all patients who underwent HIFU, the focal treatment was approved by the local
ethics committee (Candiolo cancer institute - FPO - IRCCS; registry number: 258/2018), and that all
patients who underwent RARP after HIFU signed an informed consent.

Consent for publication
Not applicable