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286
M. Mottaghi et al.
enced incontinence, and only 16.1% of the 31
patients had erectile dysfunction, dened as
insufcient erections for penetration.
Irreversible Electroporation (IRE)
As a non-thermal modality with minimal effect
on the collateral collagen and elastic bers,
nerves, and vasculature, IRE works by application of a high-amplitude electric eld, typically
involving 90 pulses of 1500 V/cm, administered
between a set of electrodes [25]. Similar to
Cryoablation, IRE is also a viable treatment for
anterior prostate cancer due to its transperineal
method. The ability to choose the length and
adjust the curvature of the exposed part of the
needle makes IRE a potentially promising modality for anterior tumors, especially in the apical
region. The Nano-knife Electroporation Ablation
trial studied 20 men with anterior tumors who
underwent IRE treatment [26]. At the 6-month
follow-up biopsy, in-eld recurrence was
observed in one-third of cases with clinically signicant disease. This outcome might be attributed
to the relatively small treatment margin of 5 mm,
which was based on the mpMRI lesion as mpMRI
tends to underestimate tumor volume, especially
in the anterior portion, by as much as 9mm [19,
27]. Scheltema and colleagues provided the most
robust IRE study to date of 229 PCa men, mostly
with intermediate-risk, localized PCa. Failurefree survival was 91%, 84%, and 69% at 3-year,
5-year, and 8-year follow-up, respectively [28].
They increased the treatment margin from 5 to
10 mm during the study after higher in-eld
recurrence rates with a 5mm margin was found.
However, the study did not specify the location of
the lesions. Continence preserved in more than
98% and potency decreased by 13% compared to
baseline, dropping from 71% to 58%. Lopez etal.
included 41 low-intermediate risk men with PCa,
out of which 17 had APC treated with IRE [22].
At a median follow-up of 36 months, 24.4% had
clinically signicant recurrent PCa. Functional
results were positive, with no urinary incontinence reported, and 91.8% of patients preserved
their potency.
Transurethral Ultrasound Ablation (TULSA)
TULSA employs high-intensity Directional
ultrasound (HIDU versus HIFU) through the urethra to generate extremely high temperatures for
the purpose of obliterating cancer cells. The procedure is performed in MRI for real-time localization with temperature monitoring. Adjustments
for the intensity, frequency, and rotational speed
of the probe could be made in real time. The ablation zone is about 30 mm, and tumors within the
rst 3mm from the urethra are likely to be spared
due to the cooling catheter [29]. Although this
novel modality has not been studied specically
on anterior tumors, freedom from salvage treatment at a median of 16–24 months was between
83% and 93%, and the overall functional outcomes were excellent in the existing studies.
Furthermore, TULSA presents as a promising
option for treating APC due to its transurethral
approach, which is advantageous since the urethra is closer to anterior tumors compared to the
transrectal HIFU method, and it also offers the
potential to simultaneously treat concomitant
benign prostatic hyperplasia. Several studies
showed urinary continence in 92–100%, and
potency preservation rates were 75–98% [30].
High-Intensity Focused Ultrasound (HIFU)
HIFU serves as an effective method for ablating
prostate cancer, offering the added benet of tissue
monitoring before and after ablation through contrast enhancement. However, employing HIFU for
anterior lesions requires careful consideration,
given its potentially reduced effectiveness for
these types of tumors. Even in an experienced
HIFU center, APCs require further treatment,
almost twice as the posterior prostate tumors [31].
The power supply for transrectal HIFU is positioned within the rectum, and ultrasound waves
must travel through various layers of tissue to
reach anterior tumors. This can result in energy
loss and disrupted ultrasound wave convergence as
they pass through multiple tissue layers.
25 Focal Therapy forAnterior Cancers
287
Simultaneous swelling of the ablation zone also
displaces the region of interest. Moreover,
increased transmission of energy through the urethra escalates the likelihood of brosis and stricture. Although these results were extracted from
relatively older devices and the newer technologies have a higher maximum anteroposterior range
(potentially able to ablate up to 45–60mm anterior
to the transducer), they still showed less efcacy in
anterior tumors versus posterior [31, 32].
Surgery (Partial Prostatectomy)
Besides the proximity of the external urinary
sphincter, neurovascular bundles converge at the
prostate apex, making this area more susceptible
to insults from thermal ablation modalities.
Anterior partial prostatectomy could be used
a
c
experimentally for APCs, especially in cases with
distal apical tumors. This procedure involves enbloc excision of TZ, anterior horns of PZ, and
AFMS (Fig. 25.5) in four steps, each depicted
with an arrow (Fig.25.4c). The pioneering experience of Villers etal. on 28 men with a median
PSA of 9.6 [1, 7–11] and follow-up of 7 (IQR
4.2–8) years showed continence and potency
(without erectile aid medications) preservation in
92% and 69% of cases, respectively [19, 33–35].
Post-op nadir was 0.36 (IQR 0.25–0.60). After a
median of 3.25 (IQR 2.4–6) years, eight cases
underwent salvage completion of radical prostatectomy due to local recurrence on biopsy
prompted by rising PSA.None of the cases developed metastasis. Of note, one out of the eight
cases had recurrent disease only on post-surgical
biopsies and subsequently underwent salvage
completion of radical prostatectomy.
b
Fig. 25.5 Anterior partial prostatectomy involves excision of the proximal urethra, the anterior portion of the
distal (submontanal) urethra, AFMS, TZ, median lobe,
apical sections of the PZ, and the anterior bladder neck.
An example of an average APC is depicted in green.
Steps: (1) Division of the dorsal venous complex and the
anterior half of the urethra at the apex. (2) Retrograde
division of the apex up to VM. (3) Division of the anterior
bladder neck. (4) Division of the posterior bladder neck
and enucleation of the median lobe followed by
BN-urethra anastomosis. BN bladder neck, BW bladder
wall, DA detrusor apron, DU distal urethra, DVP dorsal
venous complex, FC Foley catheter, ML TZ median lobe,
PS pubic symphysis, PU proximal urethra, RUM rectourethralis muscle, RW rectum wall, SS striated sphincter, SV
seminal vesicles, VM verumontanum, VEF ventral endopelvic fascia. Courtesy of Villers, A. etal., Robot-assisted
partial prostatectomy for anterior prostate cancer: a stepby- step guide. BJU Int. 2017 Jun;119 (6):968-974
288
M. Mottaghi et al.
Evolving Frontiers
Precision medicine is at the forefront of current
research efforts. It aims to customize treatment
and management for each individual by taking
into account the unique variations in their genes,
environment, lifestyle, and quality of life.
Candidates for focal therapy require precise localization of prostate cancer to deliver personalized
treatment with maximum efcacy, particularly in
the case of APCs, where diagnosis and precise
delineation of tumors are challenging. Although
mpMRI is currently the most accepted imaging
modality, it is not perfect. The integration of articial intelligence (AI) with mpMRI and novel
imaging techniques could improve current imaging capabilities [36]. Priester and colleagues
developed an AI model using mpMRI images
alongside associated whole-mount radical prostatectomy pathology slides and biopsy specimens
[37]. The model successfully predicted tumor
margins with signicantly higher mean sensitivity
(97%) compared to conventional mpMRI (37%).
The combination of prostate-specic membrane
antigen (PSMA) PET/CT and AI has been demonstrated to enhance prostate cancer staging in the
primary setting. Over time, the usage of this integration is growing, progressively evolving into a
diagnostic tool with the ability to localize tumors
and potentially serve as a guide for biopsies [38].
The adoption of these emerging technologies in
clinical practices is anticipated, driven by their
potential to reduce clinician workload, rapidly
evolve through AI advancements, and signicantly improve patient outcomes with precise and
minimally invasive methods.
Conclusion
The detection of APCs is challenging but signicantly improves with the use of mpMRI-guided
biopsies. While it is still uncertain whether the
transperineal approach is superior compared to
transrectal, it has the potential to offer further
improvements in cancer detection. FT emerges as
a highly suitable option for treating APCs, mainly
due to the tumor’s position away from the neuro-
vascular bundle. This strategic location not only
minimizes the risk of damaging these vital structures but also enhances the potential for effective
cancer control Moreover, the use of AI with imaging is poised to signicantly enhance localization,
precision, and effectiveness in diagnosing and
treating APC, especially in focal therapies.
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Oce-Based Outpatient Focal
Therapy Under Local Anesthesia
FernandoJ.Bianco andGiuseppeMaiolino
26
Abbreviations
AS Active surveillance
ASC Ambulatory surgery centers
FLA Fusion laser ablation
FT Focal therapy
MIST Minimal invasive surgical techniques
MRI Magnetic resonance imaging
OBS Ofce-based surgery
PCa Prostate cancer
RALP Robot-assisted radical prostatectomy
RCT Randomized clinical trials
RRP Radical retropubic prostatectomy
TRUS Transrectal ultrasound
TT Target therapy
Background
It is often stated that human beings can produce
groundbreaking innovation in the midst of
despair. The beginning of the past decade echoed
such sentence as the Prostate eld was shaken by
the conuence of mature results showing minimal impact on survival from both Prostate Cancer
G. Maiolino · F. J. Bianco (*)
Urological Research Network,
Miami, USA
e-mail: drbianco@research.surgery
(PCa) screening studies [1, 2] and randomized
clinical trials (RCT) [3–5] comparing active
treatment to surveillance protocols. The screening studies suggested very modest gains at the
expense of signicant harm, and the RCTs characterized such harm in the absence of survival
gains [1–5].
Notwithstanding, more than a century of
research, the management of clinically localized
PCa has faced signicant challenges in recent
years. While early studies suggested that the use
of radical surgery could improve cancer-specic
survival [6], longer-term follow-up showed no
benet in overall survival compared to watchful
waiting [3]. In fact, the PIVOT trial [7], which
was conducted during the PSA era, found no difference in all-cause survival between patients
who underwent intervention versus those who
were observed. The investigators also quantied
in their most recent report a marginal plausible
benet in survival, no longer than 6 months, if
any, after a follow-up period of 20 years and a
death count of over 70% of the cohort [4]. Finally,
the Protect trial [5], conducted in the UK, found
similar outcomes for patients undergoing surveillance compared to those who received surgery or
radiation therapy. Notably, all these studies found
that men who underwent active treatment experienced signicant detriments to their quality of
life, which has been validated by population
studies [8, 9]. The compendium of these research
was summarized by the U.S.Preventive Services
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2024
T. J. Polascik et al. (eds.), Imaging and Focal Therapy of Early Prostate Cancer,
https://doi.org/10.1007/978-3-031-66754-1_26
291
292
F. J. Bianco and G. Maiolino
Task Force, indicating positive screening and
diagnosis rates of 30% and 12%, respectively
[10]. Of those diagnosed, 2/3 would receive
denitive treatment and half would experience
harm dened as incontinence, erectile dysfunction, and other adverse events deriving from the
biopsy or treatment. Thus, at a time when 9 out of
10 men were diagnosed with clinically localized
disease, Moyet et al. representing the USPSTF
provided a “D” recommendation against
screening [10]. Importantly, by the time they
revised their recommendation to a “C” in 2018,
the rates of metastatic disease were rapidly
ascending, reaching a 1in 4 of newly diagnosed
menby 2022—10 years later, worse, in vulnerable populations [11, 12].
Theconcept of “minimally invasive” surgical
procedures became an exciting, prominent topic
in twenty-rst-century medicine, particularly in
the expansive eld of oncological surgery. Recent
years have witnessed signicant challenges in
attaining minimally invasive approaches, thanks
to the substantial advancements in medical technology. Clinicians and surgeons have swiftly
responded to morbidity concerns by embarking
on or rening procedures, redening priorities,
innovating with new learning paradigms, and balancing cost-effectiveness. In the early 2000s, the
eld of Urology, specically the surgical management of prostate cancer, was seduced by the
potential and promising effects of laparoscopic
and robotic innovations as the replacement of
open Radical Retropubic Prostatectomy (RRP)
[13, 14]. The primary goals were to improve all
outcomes due to better anatomical vision. Early
validation came from the so-called “short run”—
surgical postoperative patient morbidity
(shorteroperativeand anesthetic times, decreased
blood loss and consequently, hospital stays, with
an early return to daily activities). There was
hope for better functional outcomes: rates of
postoperative urinary incontinence and erectile
dysfunction. The clear-cut impact in the “short
run” required no randomized trial validation as
reduced postoperative patient morbidity has been
unequivocally highlighted by numerous highquality studies [15]; however, the real advantages
of robot-assisted approach in the “longer run”
would demand denitive urinary and erectile
function improvements that so far have beenmarginal at best and remain controversial: a level 1
evidence RCT executed by over 80 robotic surgeons, comparing drug vs placebo, showed an
overall rate of continence in the entire population, three months after surgery, of 73%.
Theabsence of bladder neck contractures associated with Robot-Assisted Laparoscopic
Prostatectomy (RALP),cut out a signicant risk
factor for urinary incontinence [16]. Another
well-conducted RCT found similar functional
outcomes at 24-month follow-up [17] when comparing RALP versus RRP.
Other innovators thought differently. Onik
[18] rst described a novel concept and procedure, which he coined “the male lumpectomy.”
Subsequently, Barzell and Melamed rst demonstrated the usefulness of transperineal mapping
biopsy of the prostate as a staging procedure for
localized disease [19]. This opened the door for
an improved selection of patients for either active
surveillance (AS) or Focal Therapy (FT) [20, 21].
It was this “new approach” to tackling oncological diseases that the eld of urology has undergone a profound transformation, arguably more
than any other surgical discipline, especially in
the realm of prostate cancer (PCa).
The evolution of prostate MRI imaging coincided with the novel ideas of FT, pretty much as
PSA screening did with the implementation of
the anatomical RRP described by Walsh [22].
The impact of the PI-RADS system [23] has been
immeasurable as FT gained attention and acceptance as an effective “minimally invasive”
approach for PCa. While there is no universal
denition of “minimally invasive,” such approach
encompasses three crucial concepts: (1) achieving comparable oncological outcomes to more
invasive approaches, (2) mitigating functional
impacts (primarily concerning urinary continence and sexual potency), and (3) minimizing
postoperative patient morbidity. In our view, the
minimally invasive practicality would not have
happened without fusion imaging. The development of computer software integrating and correlating two image sources was described by
Kagawa et al. [24] as a valuable technique to
26 Oce-Based Outpatient Focal Therapy Under Local Anesthesia
293
deliver 3D Conformal Radiation Therapy, more
precisely in PCa management. However, it was
the 2002 investigation report from Kaplan etal.
[25] that took image fusion or blending to the
level that is commonly used today. They demonstrated the value of MRI/TRUS fusion applied to
prostate biopsies using the RSA Inc. Image
Fusion application. Their approach was later validated by Reynier etal., who performed brachytherapy seed placement in phantoms and patients
using the MRI/TRUS Procur system [26]. Several
fusion platforms and fusion procedures have
been discussed in this book and elsewhere, all of
which have advanced the eld signicantly—
Table 26.1 provides a thorough comparison of
these medical devices. However, it is important to
note that Prostate Multiparametric MRIs, while
they consistently pinpoint the primary “dominant” lesion, have some imperfections that we
must stress. For example, they may not capture
the full extent of PCa multifocality, underestimate tumor volume, and lack precision for small
lesions. Nonetheless, fusion image registration
MRI/TRUS, and nowadays even adding the
power of CT/PET PSMA scans, helps overcome
some of these caveats and offers notable advantages, such as providing a “GPS” of the prostate,
3D geolocation of regions of interestand of the
samples taken, as well asplausible tumor boundaries. The practicality of MRI/TRUS fusion
makes it a powerful tool for FT, enhancing precision delivery and providing a safety net for these
procedures.
The introduction of MRI/TRUS-target biopsy
made it safer and easier to switch from whole
gland treatments to real FT (partial gland ablations) performed with ablative techniques such as
cryotherapy, HIFU, laser ablation, irreversible
electroporation, photodynamic therapy, and
radiation- based FT (focal brachytherapy and stereotactic body radiotherapy). All of these represent a new front of “minimally invasive”
treatments based on more anatomical and pathophysiological tailored parameters leading to
organ-sparing. Partial gland ablation or FT is a
broad term that seeks to maintain the “general
structure” of the organ and aims to treat only the
“affected” portion. Their goal is to achieve the
Table 26.1 Ofce-based eligibility based on energy source
Fusion Assessment Notes: Focalyx Fusion manufactured by Focalyx Technologies (www.focalyx.com); Artemis
ProFuse Bx manufactured by Eigen (www.eigen.com); BioJet manufactured by Medical Targeting Technologies GmbH
(www.medical- tt.com); HI-RVS (Biopsee) manufactured by Hitachi (www.hitachihealthcare.com); F-BX is Fusion
Biopsy manufactured by Focal Healthcare Inc. (www.focalhealthcare.com); iSR’obot Mona Lisa manufactured by
Biobot Surgical Pte Ltd (www.biobotsurgical.com); Koelis Trinity manufactured by Koelis (www.koelis.com); BK
Fusion manufactured by BK Medical & MIM Software (www.bkmedical.com); UroNav manufactured by Philips
(www.usa.philips.com)
a
Koelis device uses a 3D probe, the axial image is not live fusion, but reconstructed from a series of 2D sagittal images
294
F. J. Bianco and G. Maiolino
same oncological outcomes while minimizing
harm to functional outcomes. However, it bears
to ask: What’s the denition of FT? This is a big
unanswered question where every opinion is
valid so long the whole or complete prostate
organ is not treated. While the denitive answer
escapes us, we have come to terms with this
question by using the term Target Therapy (TT),
being dened as treating <40% of the prostate
gland—via single or multiple applications in the
same setting. In Fig.26.1, we provide an example
of how this denition addressed both single and
multiple target areas. In Fig.26.2, we provide a
practical example of a given patient from Biopsy
to Treatment—in this case, using MR/TRUS
Fusion Cryoablation.
When it comes to an ofce-based approach for
TT or FT, the expectation should be a consequential reduction in postoperative patient morbidity
for several reasons, such as: the perineal approach
carries an absence of surgical wound, avoids
energy delivered through the rectum, reduced
time of the procedure, avoidance of general or
regional anesthesia, and the absence of hospital
stay makes the postoperative morbidity of TT or
FT not comparable to prostatectomies performed,
neither open nor laparoscopic, nor robotic.
In this chapter, we will explore our ofcebased TT approach that has evolved over the last
10 years. This ofce-based approach portends
several advantages, such as: avoidance of general
anesthesia or sedation, expedited execution, precision, and recovery. It makes TT even less invasive than it already is, making ambulatory centers
or hospitals optional. Just as it has occurred with
techniques for Benign Prostatic Hyperplasia
(BPH) surgery, continually evolving towards
minimally invasive approaches, transitioning
from simple prostatectomy to TURP, minimal
invasive surgical techniques (MIST) such as
HoLEP, Green Laser, and nally ultra-MIST
such as prostatic embolization, Rezum, iTIND,
or transperitoneal laser ablation. Some of the current techniques of TT for prostate cancer could
also be considered as an ultra-MIST.
This ultra-MIST approach consists of performing TT for PCa in an ofce-based setting
with ablative energies using MR/TRUS Fusion
and local anesthesia. The concept of invasiveness
of a procedure for a patient is broad and not
solely limited to “anatomical issues”: hospitalization, general anesthesia, working days lost,
catheterization, or interruption of normal activities can be invasive for a patient. We emphasize
that ofce-based TT procedures require no hospitalization or general unconsciousness anesthesia,
thus permitting a prompt (or nearly immediate)
return to work and regular activities.
The ofce is becoming more and more a procedure setting as remarkably, between 1995 and
2005, the number of ofce-based procedures
doubled to 10 million annually. Since the 1980s,
the proportion of outpatient procedures performed in ambulatory surgery centers (ASCs)
and physician ofces has risen from less than 5%
for both to 38% and 17%, respectively. This trend
offers numerous advantages for both medical
providers and patients. As an example, up to the
late 1990s, cystoscopies were routinely performed in the hospital or ASC “Cystos” suites,
shifting today to an extension of the physical
exam performed in the ofce. Technology
Fig. 26.1 We dened
MR fusion target
therapy (TT) as the
ablation of 40% or less
of the prostate gland.
Our denition includes
one or multiple areas of
the prostate
a
26 Oce-Based Outpatient Focal Therapy Under Local Anesthesia
295
d
b
e
c
Fig. 26.2 The progression from a TP Fusion biopsy into
a TP Fusion treatment is shown. (a) Illustrated 2D and 3D
views from a patient’s suspicious MRI showing a PIRADS
4 lesion (magenta) and PIRADS 3 (yellow) along with the
biopsy plan where the suspicious lesions are oversampled. Importantly, random TP biopsies of systematic
areas are conducted as well. (b) Shows the path report
indicating negativity and positivity status for each core;
for the latter, the precise locations and amount of tumor as
well. (c) Provides the context of the two cores found positive and its relation to the PIRADS lesions and to negative
cores. (d, e) Provide a 3D mesh in sag, AP, and transverse
views of the intended treatment plan—in this case, using
cryoablation
advancements served for this transition. Ofcebased procedures often provide more costeffective (60–75% lower costs) alternatives to
surgical care compared to similar procedures performed in hospitals with notably less exposure to
nosocomial germs. Additionally, nonhospital settings offer patients a more personalized
environment with greater scheduling convenience, along with a perceived enhancement in
individualized attention [27–30].
In summary, this chapter reviewsdata of1800
men receiving ofce-based TT procedures in the
past decadedescribing why and how it is possible
to deliver TT to an ofce-based environment
using fusion imaging and local anesthesia as well
as itsoutcomes.
Medical Oce
In the United States, outpatient surgeries account
for up to 87% of all surgical procedures considering index hernia repair, primary total or partial
thyroidectomy, laparoscopic cholecystectomy, or