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32 Robotic High-Intensity Focused Ultrasound oftheProstate
Fig. 32.1 Example of a
robotic-HIFU platform.
(1) Image fusion
software and screens
enabling urologists to
import, view, and
perform the treatment
based on image-fusion
of magnetic resonance
imaging (MRI) and/or
the 3D mapping biopsy;
(2) an integrated
workstation cart; (3) a
specic transrectal US
(TRUS) probe with a
robotic positioning
system; and (4) motion
detector for safety
391
Safety Features
The R-HIFU systems possess several safety features, such as a cooling uid in the balloon
attached to the TRUS probe. During the procedure, the temperature of the cooling uid is continuously monitored to prevent overheating,
which could potentially harm the rectal wall.
Additionally, the rectal mucosa is maintained at
approximately 14 °C by the cooling system [12].
Another feature is the machine’s ability to track
the distance from the rectal wall to the focal
point. It refrains from ring if the rectal wall
exceeds 8mm in thickness. The system also continuously monitors the position of the rectal wall
and robotic ne movements readjust when necessary. Finally, the robotic system includes a patient
motion detector, which automatically halts the
treatment if the patient moves or if there is movement in the R-HIFU machine table.
Patient Preparation, Positioning,
andRobotic HIFU Docking
Prior to the procedure, the patients undergo specic bowel preparation protocols, which may
vary across institutions. Commonly, this involves
the self-administration of eet-enemas to ensure
the rectum is devoid of fecal matter. Dietary
restrictions also vary, and some centers may
require patients to adhere to a clear liquid diet for
24 h prior to the operation. Laxatives are usually
not necessary.
In the operating room, after general anesthesia
and endotracheal intubation are performed on
supine position, a 16 Fr Foley urethral catheter is
placed and the patient is positioned in the right
lateral decubitus with the anus and rectum
towards the edge of the table. The R-HIFU TRUS
probe is then carefully inserted into the patient’s
rectum by the operator.
392
L. S. Ramacciotti et al.
ab
Fig. 32.2 Robotic HIFU intraoperative features. (a) The
3D mapping of the magnetic resonance imaging (MRI)
and transrectal ultrasound (TRUS) fusion-guided transperineal prostate biopsy is uploaded into the robotic HIFU
system; (b) an intraoperative TRUS image is rendered and
a 3D TRUS model is created; and (c) intraoperative image
fusion model of the 3D mapping MRI/TRUS prostate
biopsy with the 3D TRUS model is created for an image
fusion guided robotic HIFU
c
Robotic HIFU Procedure
Once the robot is docked, the intraoperative
TRUS image of the prostate is acquired and fused
with the preoperative MRI for treatment planning
(Fig.32.2). This fusion of preoperative MRI data
and or the 3D mapping biopsy with the intraoperative TRUS image allows for precise identication of the target region. The region of interest is
then identied, and the surgeon delineates the
ablation margins. The robotic system then proceeds to ablate the tissue within the specied
planned volume. The ablation process continues
until the entire premapped treatment zone is covered. The operative time is dependent on the volume of tissue requiring ablation commonly
ranging from one to two hours. It is imperative to
build and deliver adequate amount of HIFU
energy to the region of interest plus 7–10 mm
margins; therefore, a larger volume of ablation is
usually preplanned. The ablation margins should
be set more lateral, medial, anterior, and posterior
(if not limited by the rectum) to what is seen on
MRI or TRUS (Fig.32.3).
Most recently, some physicians are employ-
ing a “double tap” or “dose escalation” HIFU
where two passes of partial gland HIFU ablation
of the prostate are delivered to the region of
interest with the intent to decrease the in-eld
PCa recurrence [13]. This technique has several
advantages including increasing the amount of
energy delivered and potentially decreasing a
heat-sink effect; compensate for prostate shift
and swelling during the rst treatment passage
[14]; and decreasing chances for skip lesions.
Although conceptually it makes sense, formal
data on efcacy, safety, oncologic, and functional outcomes are awaited.
32 Robotic High-Intensity Focused Ultrasound oftheProstate
393
a
Fig. 32.3 Intraoperative visualizationofa left hemigland
robotic HIFU ablation of the prostate: (a) The treatment
plan displays multiple rows of focal points (blue dots)
arranged in stacks. The orange dotted line, automatically
positioned by the machine, serves to track the rectal wall,
Intraoperative Monitoring
Several factors are continuously monitored by
the operator during the procedure, including (1)
rectal wall thickness and edema; (2) TRUS probe
balloon temperature; (3) prostate edema and
shifting; and (4) treatment plan delivery accuracy. R-HIFU provides real-time feedback,
enabling operators to monitor the treatment process effectively and make necessary adjustments,
thereby optimizing treatment outcomes and
ensuring the safety of surrounding structures.
b
ensuring safety. (b) The image reveals hyperechoic “cavitations” immediately after the treatment. The focal points
turned red indicating HIFU delivery to the corresponding
region of interest, as planned
Built-in Contrast-Enhanced Transrectal Ultrasound
The R-HIFU device also features the capability
to perform contrast-enhanced transrectal ultrasound (CeTRUS) in real time, which is benecial
for conrming that the ablation was adequately
delivered to the region of interest (Fig.32.4) [15].
Additionally, data support the CeTRUS nding
that correlate with MRI and prostate biopsy on
short-term follow-up [16, 17].
394
ab
c
L. S. Ramacciotti et al.
Fig. 32.4 Contrast-enhanced transrectal ultrasound
(CeTRUS) of the prostate. (a) Intraoperative CeTRUS
shows a lack of contrast enhancement in the ablated left
hemigland, conrming the treatment was adequately
Postoperative Care
Following the procedure, patients are monitored in
the recovery room for 2 h and are typically discharged on the same day with the indwelling urethral Foley catheter. The postoperative medication
regimen commonly includes bladder antispasmodics (anticholinergics), antiinammatory agents,
Tamsulosin (an alpha-1 blocker), and Tadalal
daily. Overall, the urethral catheter is maintained
for 7 days. However, time of catheterization varies
according to the preoperative patient self-reported
International Prostate Symptom Score (IPSS),
prostate volume,and amount and location ofthe
ablated area (quadrant vs hemi, for example).
Follow-up
Follow-up R-HIFU is similar to other focal therapy modalities and is described elsewhere in this
book. However, the authors typically perform
PSA every 3 months for the rst year, then
6-monthly thereafter. Mandatory MRI and prostate biopsy are strongly recommended in 1 year,
and then MRI annually and prostate biopsy every
2 years or “for cause” [6].
delivered. A TRUS at 3 months follow-up shows (b)
decreased Doppler signal and partially shrinkage of the
left ablated lobe and (c) lack of contrast enhancement in
the ablated area on CeTRUS
Oncologic Outcomes
Two comprehensive systematic reviews on focal
ablation therapies for PCa incorporating studies
from 1996 to 2020 have summarized HIFU outcomes [2, 3]. Among the 39 HIFU studies, 17
focused on R-HIFU (Table32.1) [6, 17–32]. The
Ablatherm platform (EDAP TMS, Vaulx-enVelin, France) was used in 82% of these studies,
followed by the Focal One platform (EDAP
TMS, Vaulx-en-Velin, France) in 41%. All studies were either retrospective or prospective, with
an absence of randomized controlled trials.
Hemiablation was performed in 82% of studies,
and focal ablation in 29%.
A total of 1194 patients were included in the
analysis, with a median follow-up period of 25
months (ranging from 6 to 127 months). The
median interquartile range (IQR) for the absence
of clinically signicant prostate cancer in the
treated area was 86% (84–90%) (Table32.2). A
median biochemical recurrence rate, most commonly dened as nadir +2 ng/mL [33], of 9.6%
(9.1–16.3%) was reported in six studies [6,
20–22, 25, 30]. The median rate of salvage ther-
apy was 19% (11–27%).
32 Robotic High-Intensity Focused Ultrasound oftheProstate
PCa risk
stratication, n (%)
NR
NR NR
3 + 3: 10 (83.3)
Low: 17 (54.8)
Intermediate: 11
(42.3)
High: 12 (46.2)
3 + 4: 2 (16.7)
GG6≤: 19
(61.3)
GG7: 10 (32.2)
Low: 24 (48)
Intermediate: 26
(52)
GG8: 2 (6.5)
3 + 3: 30 (60)
3 + 4: 14 (28)
4 + 3: 6 (12)
NR
Low: 26 (47)
Intermediate: 26
(47)
3 + 3: 58 (86.6)
3 + 4: 9 (13.4)
<6: 36 (65)
3 + 4: 13 (24)
4 + 3: 4 (7)
High: 3 (6)
NR
>8: 2 (4)
GG ≤ 6: 82 (74)
GG7: 29 (26)
NR
RARP + PGA: 3
+ 3: 355 (75.2);
188 (79.7)
3 + 4: 117
(24.8); 48 (20.3)
NR
NR
NR
c
3 + 3 (3 + 3 = 6
− 3 + 4 = 7)
3 + 3: 24 (44)
7: 31 (56)
GG ≤ 7
395
(continued)
b
b
Preprocedural PSA
(ng/ml), median
(IQR) Gleason, n (%)
10.8 (3.5–20)
7.3 (2.6–10)
c
b
Length of
follow-up (mo),
median
No. of
patients
14 12 (6–27)
no intention to treat
Ablatherm Hemiablation with
Ablatherm Hemiablation 12 127 (90–133)
d
5.3 (0.3–11)
c
Ablatherm Hemiablation 31 38 (12–61)
d
d
6.3 (3.9–8.3)
c
d
Ablatherm Hemiablation 50 40 (6–94)
d
6.1 (1.6–15.5)
6.9 (4.5–9.4)
d
Ablatherm Hemiablation 71 12 (6–50)
Ablatherm Hemiablation 55 36 (16–56)
e
e
7.12 (± 2.53)
e
Hemiablation 236 38 (±21.5)
Ablatherm Hemiablation 111 30 (14.1) 6.2 (± 2.5)
Ablatherm +
focal one
e
e
6.2 (±2.1)
6.18 (±2.46)
e
e
Hemiablation 54 17 (±4.5)
Hemiablation 55 33 (±16)
Ablatherm +
focal one
Ablatherm +
focal one
e
7.8
e
Ablatherm Hemiablation 35 12
Retrospective case
series
Retrospective case
series
Prospective
development study
References Design HIFU machine Ablation template
Beerlage etal.
(1991) [18]
El Fegoun etal.
(2011) [19]
van Velthoven etal.
Table 32.1 Characteristics of the robotic HIFU studies included
(2014) [20]
Prospective
development study
Prospective
van Velthoven etal.
(2016) [21]
Feijoo etal. (2016)
development study
Retrospective
cohort study
[22]
Albisinni etal.
(2017) [23]
Prospective
development study
Propensity-score
matched analysis
Rischmann etal.
(2017) [24]
Garcia-Barreras
etal. (2018) [25]
Prospective
development study
Retrospective
cohort study
Ganzer etal.
(2018) [26]
Anoot etal. (2019)
[27]
Retrospective case
series
Glybochko etal.
(2019) [28]
396
PCa risk
stratication, n (%)
Low: 5 (6.7)
3 + 3: 6 (8.0)
Intermediate: 70
(93.3)
Low: 12 (57.1)
Intermediate: 8
(38.1)
3 + 4: 53 (70.7)
4 + 3: 16 (21.3)
3 + 3: 15
3 + 4: 2
4 + 3: 4
High: 1 (4.8)
Very low: 8 (8)
Low: 20 (20)
Intermediate
GG1: 29 (29)
GG2: 55 (55)
GG3: 11 (11)
favorable: 50 (50)
Intermediate
unfavorable: 17
(17)
High: 5 (5)
GG4: 5 (5)
NR
GG1: 17 (32.7)
GG2: 24 (46.2)
GG3: 6 (11.5)
GG4: 3 (5.8)
GG5: 2 (3.8)
Low: 103 (54)
Intermediate: 87
(46)
NR
3 + 3: 130 (68)
3 + 4: 56 (29)
4 + 3: 4 (2.1)
3 + 3: 14 (42)
3 + 4: 13 (39)
L. S. Ramacciotti et al.
4 + 3: 5 (15)
4 + 4: 1 (3)
d
Preprocedural PSA
(ng/ml), median
(IQR) Gleason, n (%)
5.87 (4.65–7.44)
c
Length of
follow-up (mo),
median
No. of
patients
Focal one Focal ablation 75 6
d
8.3 (6.2–10.2)
e
Focal one Focal ablation 21 12
d
5.9 (4.5–7.2)
d
20 (13–29)
a
Ablatherm Hemiablation 100
c
5.5 (1.6–25.9)
c
52 12
quadratic, or
subtotal
Ablatherm Focal, hemi,
d
d
7.1 (5.5–9.0)
c
Focal ablation 190 37
Ablatherm +
focal one
32 NR 7.2 (5.3–8.4)
stick ablation
Focal one Focal/hemi/hockey
Table 32.1 (continued)
Prospective
development study
Prospective
References Design HIFU machine Ablation template
Mortezavi etal.
(2019) [29]
Rosenhammer
development study
etal. (2019) [30]
Retrospective
cohort study
Abreu etal. (2020)
[6]
Prospective cohort
study
Nahar etal. (2020)
[31]
Retrospective
Tourinho-Barbosa
cohort study
Retrospective
cohort study
etal. (2020) [32]
Bacchetta etal.
(2020) [17]
Mean (range)
Depending on prostate size and machine availability, either the Sonablate 500 or the Ablatherm devices were utilized. In total, 15 cases were reported to have been performed
No. number, mo months, PSA prostate-specic antigen, GG grade group, PCa prostate cancer
a
Median (range)
using the Ablatherm device.
b
c
Median (interquartile range)
Mean (standard deviation)
d
e
32 Robotic High-Intensity Focused Ultrasound oftheProstate
OS
(%)
RFS
(%)
Salvage
therapy (%)
BCR
(%)
83
yr)
38
(10
yr)
18.5 NR 82.7 100
a
28 37.5 58 87
9.7 NR NR NR
NR 9.9 NR 98
9 21.2 NR NR
397
(continued)
NR 19.6 NR NR
c
NR 8 NR NR
a
Postprocedural PSA
level (ng/ml)
CSPCa
untreated area
(%)
PCa in
untreated area
(%)
CSPCa in
treated area
(%)
PCa in
treated area
(%)
b
b
(0.52–2.07)
Nadir: 2.6
b
(0.2–11.1)
c
c
c
c
Nadir: 2.93 (± 2.3)
NR NR NR NR NR NR
mo)
NR 11.4 (at 12
mo)
Absence of
CSPCa in treated
area (%)
No. of
patients
14 NR 28.6 NR 92.9 NR NR NR NR NR 100
12 NR NR NR NR NR NR NR 41.6 90 (5
References
Beerlage etal.
(1991) [18]
El Fegoun etal.
Table 32.2 Oncologic outcomes of the robotic HIFU studies included
(2011) [19]
31 NR NR NR 11.1 NR Nadir: 0.93 (0–8.9)
50 NR 37.5 NR 37.5 NR Nadir 0.91
71 83.6 16.4 NR 9 NR 3.8 (2.0–5.7)
van Velthoven etal.
(2014) [20]
van Velthoven etal.
(2016) [21]
Feijoo etal. (2016)
[22]
55 NR 13 NR 13 NR NR NR 13 NR 90
111 95 12 5 19 7 2.3 (± 1.7)
236 86 22 14 7 6 4.1 (± 3.75)
Albisinni etal.
(2017) [23]
Rischmann etal.
(2017) [24]
Garcia-Barreras
54 91.8 26.5 8.2 34.7 2 2.9 (± 1.9)
55 NR NR 22 18 1.8 NR NR 18.2 NR 100
etal. (2018) [25]
Ganzer etal. (2018)
[26]
Anoot etal. (2019)
[27]
35 NR 0 (at 6
Glybochko etal.
(2019) [28]
75 58.8 NR 20.5 NR 20.6 2.46 (± 1.91)
21 NR 19 4.7 19 NR 2.85 9.5 19 NR NR
Mortezavi etal.
(2019) [29]
Rosenhammer etal.
(2019) [30]
398
OS
(%)
RFS
(%)
Salvage
therapy (%)
BCR
(%)
8 NR 73 100
b
a
c
Postprocedural PSA
level (ng/ml)
CSPCa
untreated area
(%)
NR 3.3 NR 100
L. S. Ramacciotti et al.
NR 33.4 52 NR
b
PCa in
untreated area
CSPCa in
treated area
PCa in
treated area
Absence of
CSPCa in treated
No. of
Table 32.2 (continued)
(%)
(%)
(%)
area (%)
patients
100 86.2 17 14 40 17 Nadir 1.3 (0.7–2.6)
52 NR 16.7 NR 13.3 NR 2.23
References
Abreu etal. (2020)
[6]
Nahar etal. (2020)
[31]
190 NR 30 NR 17 NR Nadir 2.6 (1.4–4.5)
32 NR 54 30 NR NR NR NR NR NR NR
Tourinho-Barbosa
etal. (2020) [32]
Bacchetta etal.
(2020) [17]
No. number, PCa prostate cancer, CSPCa clinically signicant PCa, PSA prostate-specic antigen, BCR biochemical recurrence, RFS recurrence-free survival, OS overall
survival.
Median (interquartile range)
Median (range)
Mean (standard deviation)
a
b
c
32 Robotic High-Intensity Focused Ultrasound oftheProstate
399
Functional Outcomes
Continence was well-preserved following
R-HIFU and similar between all studies
(Table32.3). Pad-free rates ranged from 93% to
100%, with most studies reporting no signicant
difference between baseline and postablation
scores. Regarding erectile function posttreat-
Table 32.3 Robotic HIFU functional outcomes
PROM
References
El Fegoun etal.
(2011) [19]
van Velthoven etal.
(2014) [20]
van Velthoven etal.
(2016) [21]
Feijoo etal. (2016)
[22]
Albisinni etal.
(2017) [23]
Rischmann etal.
(2017) [24]
Garcia-Barreras
etal. (2018) [25]
Ganzer etal.
(2018) [26]
Glybochko etal.
(2019) [28]
Mortezavi etal.
(2019) [29]
continence Continence
NR 100% pad-free NR NR NR
NR 100% pad-free NR Potency
Physicianreported rates
ICS, IPSS NR IIEF-5 Median (range)
Patientreported rates
IPSS 97% pad-free IIEF-5 Potency
IPSS Mean score:
ICS, IPSS 94% pad-free IIEF-5 Mean scores:
IPSS Mean score
EPIC, IPSS 98.4% pad-free IIEF-15 Potency
94% pad-free Physician-
94.5% pad-free Patient-reported
– Pre-
ablation: 5.44
± 4.77
– Post-
ablation: 5.61
± 4.45
(range):
– Pre-
ablation: 4
(0–26)
– Post-
ablation: 3
(1–25)
ment, potency preservation ranged from 77.6% to
90.5% of patients. Notably, one study reported a
complete return to baseline erectile function at 12
months [31]. New use of phosphodiesterase-5
inhibitors post-treatment was reported in three
studies [20, 26, 29], affecting 13.8–23.5% of
patients.
New use of
PROM for
erectile function Erectile function
preservation: 80%
Potency
reported rates
rates
IIEF-5 Potency
IIEF-5 Mean score
preservation: 80%
– Pre-ablation:
20 (0–25)
– Post-ablation:
16 (0–25)
Potency
preservation: 80%
preservation:
78.4%
preservation:
90.5%
– Pre-ablation:
17.6 ± 6.1
– Post-ablation:
13.6 ± 8.6
(range):
– Pre-ablation:
20 (0–25)
– Post-ablation:
16 (0–25)
preservation:
77.6%
PDE-5 inhibitor
(%)
13.8
NR
NR
NR
NR
NR
23.5
NR
25.3
(continued)
400
Table 32.3 (continued)
PROM
References
Abreu etal. (2020)
[6]
Nahar etal. (2020)
[31]
Tourinho-Barbosa
etal. (2020) [32]
PROM patient-reported outcome measures, PDE-5 phosphodiesterase-5, NR not reported, ICS International Continence
Society, IPSS International Prostate Symptom Score, IIEF International Index of Erectile Function, EPIC expanded
prostate cancer index composite, SHIM sexual health inventory for men, IQR interquartile range, ED erectile dysfunction, mo months
continence Continence
IPSS Median (IQR)
scores:
– Pre-
ablation: 9
(3–15)
– Post-
ablation: 6
(3–11)
EPIC/IPSS Return to
baseline at 12
mo
IPSS 93% pad-free NR NR NR
PROM for
erectile function Erectile function
IIEF-5 Median (IQR)
scores:
– Pre-ablation:
22 (18–25)
– Post-ablation:
21 (16–24)
EPIC/SHIM Return to baseline
at 12 mo
L. S. Ramacciotti et al.
New use of
PDE-5 inhibitor
(%)
NR
NR
Complications
The median (IQR) incidence of Clavien-Dindo
grade 3 or higher complication rates was 3.4%
(2.8–4.8%) (Table 32.4). The most common
complications were urinary tract infections and
urinary retention, with reported rates ranging
from 0% to 38.5% and 3.4% to 14.3%, respectively. Urethral stricture rates ranged from 0% to
4%. Of the 11 studies reporting recto-urethral stula complication rates—a highly concerning and
severe complication post-HIFU-10 reported no
instance of stulas [6, 18, 20–24, 26, 30, 31].
One study reported a 0.3% occurrence of stulas
[32]. Overall, a total of 749 patients underwent
R-HIFU with 1 (0.1%) case of recto-urethral stula reported.