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- •Foreword
- •Preface
- •Contents
- •Contributors
- •Imaging
- •Personal Preference
- •Introduction
- •Traditional Radical Therapies
- •Active Surveillance
- •Why Consider Focal Therapy?
- •Cancer Treatment Needs
- •Functional Outcomes
- •Conclusion
- •Introduction
- •Focal Therapy Candidates
- •The Index Lesion Theory
- •Further Prospective
- •Conclusions
- •References
- •Introduction
- •Renal Mass Biopsy
- •Approach
- •Cryoablation
- •Treatment Temperature
- •Radiofrequency Ablation
- •Treatment Temperature
- •Intraoperative Monitoring
- •Cryoablation
- •Radiofrequency Ablation
- •Recommended Imaging Follow-Up Protocol
- •Emerging New Ablative Modalities
- •Microwave Ablation
- •Irreversible Electroporation
- •Radiation Therapy
- •Oncological Outcomes
- •Local Recurrence-Free Survival
- •Overall Survival
- •Cryoablation Versus Radiofrequency Ablation
- •Complications
- •Conclusion
- •References
- •Introduction
- •Informed Consent
- •Why Focal Therapy?
- •References
- •References
- •Introduction
- •Conclusions
- •References
- •Introduction
- •Conclusions
- •References
- •Introduction
- •Prostate MRI
- •Robotic Surgery
- •Conclusion
- •References
- •Introduction
- •References
- •Introduction
- •Conclusions
- •References
- •Decipher
- •Oncotype DX
- •Prolaris
- •Limitations
- •Conclusion
- •References
- •Background
- •Androgen Manipulation
- •Conclusion
- •References
- •Introduction
- •Genomic Biomarkers
- •Genomic Heterogeneity
- •Targeted Biopsy Outcomes
- •Outcomes After Active Surveillance
- •Outcomes After Radical Prostatectomy
- •Conclusions
- •References
- •Introduction
- •Early Prostate MRI Consensus Meetings
- •PI-RADS v2
- •PI-RADS v2.1
- •PI-RADS Vs. Likert Score
- •MRI-Targeted Biopsies
- •Reporting Cancer Recurrence
- •MRI After Focal Therapy
- •Conclusion
- •References
- •MR Segmentation
- •US Segmentation
- •MR-US Registration/Fusion
- •Conclusion
- •References
- •Introduction
- •Ultrasound Elastography
- •Strain Elastography
- •Shear Wave Elastography
- •Patient Factors During FB
- •Discussion
- •Learning Curve
- •Core Number Optimization
- •Transrectal Versus Transperineal
- •Future Directions
- •Acoustic Radiation Force Impulse (ARFI) Imaging
- •Quantitative Ultrasound
- •Micro-Ultrasound
- •Multiparametric Ultrasound
- •Conclusions
- •References
- •Multi-Parametric Magnetic Resonance Imaging
- •References
- •Introduction
- •Cognitive Fusion
- •In-Bore MRI-Guided Biopsy
- •Software-Based Image Coregistration
- •Registration Algorithms
- •Biopsy Needle Tracking
- •Biopsy Approach
- •Commercial Systems
- •Electromagnetic Tracking
- •Mechanical Position Encoders
- •Image-Based Tracking
- •Discussion
- •Conclusion
- •References
- •Introduction
- •Complications
- •Urinary Retention
- •Bleeding
- •Conclusion
- •References
- •Introduction
- •Institutional Examples
- •Setting
- •Results
- •Discussion
- •Summary
- •References
- •Introduction
- •PET-Guided Targeted Prostate Biopsy
- •Gallium-68 (68Ga)-Radiolabeled PSMA Ligands
- •Fluorine-18 (18F)-Radiolabeled PSMA Ligands
- •Gastrin-Releasing Peptide Receptor (GRPR)
- •Future Outlook
- •Conclusion
- •References
- •Introduction
- •Approach
- •Sampling
- •Core Length
- •Histologic Submission
- •BxChip™
- •Reporting Results
- •References
- •Introduction
- •Location: Treatment Factors
- •References
- •Introduction
- •Focal Therapy Nomenclature
- •Nerve-Sparing (Unilateral or Bilateral)
- •Hemi-Ablation
- •Anterior Hockey-Stick Ablation (Anterior Three-Fourth)
- •Posterior Hockey-Stick Ablation (Posterior Three-Fourth)
- •Targeted Focal Therapy
- •Quadrant (Zonal) Ablation
- •Conclusions
- •References
- •Introduction
- •Cryotherapy
- •Irreversible Electroporation (IRE)
- •Transurethral Ultrasound Ablation (TULSA)
- •High-Intensity Focused Ultrasound (HIFU)
- •Surgery (Partial Prostatectomy)
- •Evolving Frontiers
- •Conclusion
- •References
- •Background
- •Procedure Selection
- •Patients’ Selection
- •Anesthesia
- •Perioperative Protocols
- •Procedure
- •Postoperative Period
- •Outcomes
- •Procedure Feasibility
- •Adverse Events
- •Outcomes
- •Conclusion
- •References
- •Clinical Background
- •Radiotherapy Techniques
- •Clinical Evidence About High-Dose Rate Interventional Radiotherapy (HDR IRT)
- •Clinical Evidence About Low-Dose Rate Interventional Radiotherapy (LDR IRT)
- •Clinical Evidence About Focal External Beam Radiotherapy (ERT)
- •Discussion
- •References
- •28: Focal Cryotherapy
- •Introduction
- •Focal Cryotherapy Procedure
- •Contemporary Focal Cryotherapy Series
- •Primary Focal Cryoablation
- •Salvage Focal Cryotherapy
- •Surveillance
- •Future Developments
- •Imaging
- •Cryotechnology
- •Immune Enhancer
- •References
- •Background
- •Energy Principles: Basic Science
- •Conclusion
- •References
- •Introduction
- •Early Studies
- •Phase 1 Clinical Trial (“Subtotal” Ablation)
- •Phase II (“TACT”) Clinical Trial (“Whole Gland” Ablation)
- •Patient Selection
- •Preoperative Imaging Planning
- •Intraoperative Considerations
- •Follow-Up Routine Post-Focal TULSA
- •Summary
- •References
- •Vapor 1 Study Results
- •References
- •Introduction
- •Robotic HIFU
- •Safety Features
- •Robotic HIFU Procedure
- •Intraoperative Monitoring
- •Built-in Contrast-Enhanced Transrectal Ultrasound
- •Postoperative Care
- •Follow-up
- •Oncologic Outcomes
- •Functional Outcomes
- •Complications
- •Conclusions
- •References
- •Indications
- •Contraindications
- •Preprocedure Workup
- •Technique
- •Outcomes
- •Complications
- •Controversies
- •Conclusion
- •References
- •Introduction
- •Posttreatment MRI Findings
- •High-Intensity Focused Ultrasound (HIFU)
- •Focal Laser Ablation (FLA)
- •Irreversible Electroporation (IRE)
- •Focal Cryotherapy (FC)
- •Photodynamic Therapy (PDT)
- •Future Perspectives
- •Conclusion
- •References
- •Introduction
- •Oncological Outcomes
- •Biochemical Recurrence
- •Functional Outcomes
- •Perioperative Complications
- •Urinary
- •Sexual
- •Bowel
- •Decision Regret
- •Conclusion
- •References
- •36: Assessing Functional Outcomes After Focal Therapy
- •High-Intensity Focused Ultrasound (HIFU)
- •Cryotherapy
- •Irreversible Electroporation (IRE)
- •Focal Brachytherapy
- •Focal Laser Ablation (FLA)
- •Photodynamic Therapy (PDT)
- •Microwave Ablation
- •Partial Prostatectomy
- •Bipolar Radiofrequency Ablation (bRFA)
- •Prostatic Artery Embolization (PAE)
- •Urinary Function
- •IPSS
- •EPIC
- •ICIQ-SF
- •Erectile Function
- •IIEF
- •EPIC
- •Safety Outcomes
- •Clavien-Dindo
- •CTCAE
- •Physical/Mental Outcomes
- •SF-12
- •Monitoring Patients After Focal Therapy
- •References
- •Introduction
- •PSA Nadir
- •PSA Density
- •Other Molecular Biomarkers
- •Follow-Up Protocols After FT
- •References
- •Introduction
- •Postbrachytherapy Treatment Changes
- •Post High-Intensity Focused Ultrasound (HIFU) Treatment Changes
- •Post Cryotherapy Treatment Changes
- •Post Laser Ablation Changes
- •Post Photodynamic Therapy Changes
- •Post Irreversible Electroporation Changes
- •Interstitial Microwave Thermal Therapy
- •Radiofrequency Ablation
- •References
- •39: Salvage Treatment Following Focal Therapy
- •Introduction
- •Salvage Treatment Modalities
- •Repeat Ablation
- •Salvage Radical Treatment
- •Salvage Radical Prostatectomy
- •Salvage Radiotherapy
- •References
- •Introduction
- •Ensuring Appropriate Quality
- •Conclusion
- •References
- •Patient Selection
- •Posttreatment Follow-Up
- •Conclusions
- •References
- •Index

7 Focal Therapy andActive Surveillance ofProstate Cancer inEast andSouth-East Asia
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OS, et al. Prostate-specic antigen vs prostatespecic antigen density as a predictor of upgrading
in men diagnosed with Gleason 6 prostate cancer by
contemporary multicore prostate biopsy. BJU Int.
2012;110(11 Pt B):E494–E9.
41. Imamoto T, Utsumi T, Takano M, Komaru A,
Fukasawa S, Suyama T, etal. Development and external validation of a nomogram predicting the probability of signicant Gleason sum upgrading among
Japanese patients with localized prostate cancer.
Prostate cancer. 2011;2011:754382.
42. Tan G, Ho H, Huang H, Cheng CWS, Lau
WKO.Pathological outcome in men with prostate cancer suitable for active surveillance after radical prostatectomy. Proc Singap Healthc. 2012;21(2):102–8.
43. Tay KJ, Mendez M, Moul JW, Polascik TJ. Active
surveillance for prostate cancer: can we modernize
contemporary protocols to improve patient selection
and outcomes in the focal therapy era? Curr Opin
Urol. 2015;25(3):185–90.
44. Fujii S, Hayashi T, Honda Y, Terada H, Akita R,
Kitamura N, et al. Magnetic resonance imaging/
transrectal ultrasonography fusion targeted prostate biopsy nds more signicant prostate cancer in
biopsy-naïve Japanese men compared with the standard biopsy. Int J Urol. 2020;27(2):140–6.
45. Matsuoka Y, Ueno Y, Uehara S, Tanaka H, Kobayashi
M, Tanaka H, et al. Deep-learning prostate cancer
detection and segmentation on biparametric versus
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value of dynamic contrast-enhanced imaging. Int J
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46. Shoji S, Kaya T, Tanaka Y, Uemura K, Kusaka
T, Takahashi K, et al. Usefulness of LacdiNAcglycosylated prostate-specic antigen density for predicting pathological ndings of magnetic resonance
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Chinese men. Asian J Androl. 2023;25(6):674–9.
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Acceptance andChallenges
intheAdoption ofFocal Therapy
forProstate Cancer inSouth
America
RubenOlivares, NicolasSoputro, RafaelTourinhoBarbosa, EzequielBecher, SauloBorboremaTeles,
andArieCarneiro
8
Introduction
Prostate cancer (PCa) is a signicant health concern globally, and South America is no exception
[1, 2]. Traditionally, active surveillance and radical treatments such as surgery and whole-gland
radiation therapy have been the primary options
for management. However, these treatments can
lead to substantial side effects that negatively
impact patients’ quality of life. Focal therapy
(FT), a targeted approach that aims to treat only
the cancerous areas within the prostate, has
emerged as a potential alternative.
Through an analysis of the current landscape,
including awareness and knowledge levels,
patient preferences, healthcare infrastructure,
cost considerations, regulatory frameworks, and
the role of multidisciplinary collaboration, this
chapter examines the acceptance and barriers
R. Olivares (*) · N. Soputro
Glickman Urological Institute, Cleveland Clinic,
Cleveland, OH, USA
e-mail: olivarr@ccf.org
R. Tourinho-Barbosa
Department of Urology, Hospital Cardio Pulmonar—
Rede D’Or, Salvador, Brazil
E. Becher
CDU—Centro de Urologia, Buenos Aires, Argentina
S. B. Teles · A. Carneiro
Department of Urology, Hospital Israelita Albert
Einstein, São Paulo, Brazil
hindering the widespread adoption of FT as a
treatment for PCa in South America.
Awareness andKnowledge Among
Healthcare Professionals
The level of familiarity with FT among urologists
in South America may vary across different countries, regions, and institutions. Factors such as
afliation with academic centers, exposure to
international experiences, participation in continuing medical education, and involvement in local
research and clinical practice play a role in determining the level of awareness among urologists.
Urologists afliated with renowned research
and academic centers in South America often
exhibit a greater understanding of FT due to their
collaborations with international experts and
involvement in clinical trials. Additionally, access
to international scientic journals and online
platforms facilitates staying up to date with the
latest developments in the topic.
Active participation in continuing medical
education programs, conferences, and workshops
also contributes to a higher level of awareness.
These educational activities provide opportunities for urologists to exchange knowledge and
learn about the latest treatment modalities.
Urology congresses worldwide, including the
annual meetings of the American Urological
Association (AUA) and the European Urological
© 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_8
87

88
R. Olivares et al.
Association (EAU), have recognized the growing
importance of FT and its potential impact on PCa
treatment. As a result, these congresses have
increasingly incorporated a variety of courses,
hands-on workshops, and instructional activities
related to this minimally invasive modality [3–6].
These workshops provide urologists with the
practical training and skills necessary as a starting point for implementing FT techniques in their
local centers of origin [7]. They often include live
demonstrations, simulation exercises, and interactive sessions to enhance participants’ understanding of FT procedures and technologies.
Moreover, these congresses typically invite
renowned experts in the eld as guest speakers,
allowing attendees to learn from their expertise
and gain insights into the latest advancements in
this area. The presence of such experts facilitates
knowledge exchange, practical recommendations, and starting tips and fosters discussions on
the challenges and opportunities associated with
FT in South America.
Participation in professional networks, such as
the Focal Therapy Society, can enhance awareness through information sharing, white papers,
consensus, and collaborative opportunities.
Urologists who engage inlocal research initiatives and registries or have integrated FT, as early
adopters, into their clinical practice are more
likely to have a deeper understanding of this
treatment approach. Such rsthand experience
allows them to assess the efcacy and safety of
FT within the context of South America.
Although FT is gaining recognition, it may
still be relatively less familiar among urologists
compared to more established treatment options
like surgery and radiation therapy. As a relatively
newer approach, it requires high-level evidence,
studies reporting on hard outcomes, and time for
acceptance and dissemination within the medical
community.
Patient Access toHealthcare System
Timely diagnosis and early detection of PCa are
essential for identifying suitable candidates. If
patients have convenient access to healthcare facilities and regular screenings, there is a higher likelihood of detecting PCa at an early stage when FT
can be a viable treatment option [2]. In contrast, if
access to the healthcare system is challenging or
limited, patients may face delays in diagnosis and
treatment. As a result, prostate cancer may progress to more advanced stages, making FT less feasible. When the cancer has already advanced,
radical treatments like surgery, radiation therapy,
or systemic therapies like androgen deprivation
therapy might become the only available options.
Socioeconomic factors, geographical location, and healthcare infrastructure disparities can
impact patient access to the healthcare system in
South America. Limited resources, long waiting
times, and nancial constraints can create barriers to timely diagnosis and subsequent treatment
initiation. These barriers contribute to a higher
proportion of patients presenting with advancedstage prostate cancer, reducing the suitability of
FT as a treatment option. Access to good quality
multiparametric magnetic resonance imaging
(MRI) is crucial for FT patient selection. These
sorts of high-quality scans are not commonly
found in South America, and moreover, patient
access is limited. This topic, however, will be
thoroughly discussed later in the chapter.
Patient Preferences andShared
Decision-Making
It is important to consider that patient satisfaction
and regret after treatments for PCa are multifactorial, inuenced by various factors, including individual expectations, treatment outcomes
(oncological and functional), and post-treatment
support. Shared decision-making, proper counseling, and realistic expectations are essential components in ensuring patient satisfaction and minimizing
regret, regardless of the treatment modality chosen.
The type of patient access to the healthcare system
is another factor inuencing the adoption of FT as
a treatment for prostate cancer in South America.
Satisfaction Rates Studies evaluating satisfaction rates after FT are limited. However, available
evidence suggests that many patients who undergo

8 Acceptance andChallenges intheAdoption ofFocal Therapy forProstate Cancer inSouth America
89
FT report high levels of satisfaction. This is primarily attributed to the preservation of erectile
function, urinary continence, and overall quality
of life, as FT specically targets and treats only
the cancerous areas within the prostate, minimizing damage to surrounding healthy tissue [8].
Regret Rates Regret rates after FT appear to be
relatively lower compared to radical prostatectomy (RP). FT focuses on preserving functional
outcomes and minimizing treatment-related side
effects. This may contribute to a decreased likelihood of regret. However, it is important to note
that long-term data on FT outcomes, including
functional outcomes and cancer control, are still
evolving, and appropriate case selection plays a
crucial role in determining outcomes and potential regret. Moreover, there are no data available
examining treatment satisfaction/regret in the
South American population regarding either radical or focal alternatives.
Regret rates after RP may be associated with
postoperative complications, such as urinary
incontinence or erectile dysfunction, which can
signicantly impact a patient’s quality of life and
sexual function. The surgical experience and volume can inuence outcomes and potentially
reduce complications from RP, which may subsequently impact regret rates. Studies have shown
that surgeons with higher caseloads and greater
experience performing RP tend to have better
surgical outcomes [9–11].
This situation is completely mirrored in FT:
when surgeons are more experienced and have
performed a higher number of FT procedures,
they often develop rened surgical techniques,
improve their skills, and gain a better understanding of patient selection criteria. This expertise
can lead to more precise procedures, better preservation of urinary and sexual function, and
improved oncological outcomes.
funded by the government, tend to handle a
higher patient volume but often face challenges
in sustaining basic care and incorporating new
technologies due to limited resources and rudimentary nancing models.
On the other hand, new technologies are more
commonly adopted by private hospitals, where
patients with nancial means, such as those covered by insurance or possessing private resources,
seek advanced and technologically sophisticated
treatments. However, it is important to note that
even in private hospitals, the proportion of the
population with the nancial capacity to afford
such treatments remains limited.
The high patient volume in public services
combined with the nancial constraints faced by
these institutions can hinder the widespread
adoption of innovative technologies like FT.
Additionally, the limited access to private hospitals and their associated technologies restricts
the availability of these advanced treatments to a
smaller segment of the population. This restriction prevents surgeons from gaining experience
quickly, which would lead to improved
outcomes.
In order to achieve widespread adoption of FT
as a treatment for prostate cancer, it is imperative
to address the cost barriers and ensure the integration of this technology in both public and private healthcare systems.
We understand that until such advancements
are made, FT will remain conned to a limited
number of specialized centers, accessible primarily to those who can afford the associated
expenses. However, by actively working toward
cost reduction and technology integration, we
can strive toward a future where FT becomes
more widely available and accessible to a broader
patient population [12].
Prostate MRI
Volume ofPatients Suitable forFT
Healthcare services in South America typically
encompass both public and private sectors, each
with varying nancial models. Public services,
Access to prostate MRI plays a crucial role in
determining candidacy of patients for FT.MRI is
a valuable tool for assessing the location, extent,
volume, and proximity of the PCa lesions to
important structures. The timely availability,
cost, and expertise of radiologists who interpret

90
R. Olivares et al.
these exams signicantly inuence candidacy for
and access to this treatment modality.
Availability of MRI Equipment: The availability of MRI equipment specically dedicated to
prostate imaging can vary across facilities in
South America. Larger hospitals and specialized
centers are more likely to have dedicated MRI
machines for prostate imaging, which is essential
for accurate cancer localization and treatment
planning. However, the availability of such
equipment may be limited in smaller or public
centers, potentially impacting patient access to
this diagnostic tool.
Cost of MRI Exams: The cost associated with
an MRI of the prostate can be a signicant barrier
to access for many patients. MRI exams can be
expensive, particularly when patients bear the
full cost or when insurance coverage is limited.
High out-of-pocket expenses might dissuade
some individuals from pursuing an MRI as part
of their diagnostic workup, potentially limiting
their eligibility for FT.
Experience and Expertise of Radiologists:
The expertise of radiologists who interpret prostate MRI exams is critical for accurate cancer
detection and localization. Experienced radiologists with specialized training in prostate imaging can provide more reliable and comprehensive
reports, guiding urologists in determining appropriate candidates for FT.However, the availability of skilled radiologists with high-volume
exposure in interpreting prostate MRI exams may
vary across different regions in South America
[13, 14].
The Prostate Imaging Reporting and Data
System (PI-RADS) classication is indeed an
important effort toward standardization in the
acquisition and reporting of MRI of the prostate.
PI-RADS provides a standardized framework for
radiologists to assess, characterize, and communicate clinically signicant PCa based on MRI
ndings.
Addressing these factors is vital to improving
access to MRI of the prostate for patients considering FT.Efforts should focus on increasing the
availability of dedicated prostate MRI equipment, exploring options for cost reduction or
insurance coverage, and providing training
opportunities for radiologists to enhance their
expertise in prostate imaging.
Risk Stratication: Fusion Vs
Random Biopsy
One crucial aspect of adopting FT for PCa is
ensuring a high level of concordance and accurate risk stratication between the initial
biopsy and the nal pathology. It is essential to
minimize the rate of upgrading, in which the
Gleason score or tumor volume is higher in the
surgical specimen compared to the biopsy
results [15, 16]. This ensures that patients
selected for FT are appropriately categorized
and that the treatment targets the exact location
and extent of the cancer.
The need for almost perfect risk stratication
and alignment between the biopsy and nal
pathology underscores the importance of centralized expertise and dedicated resources
within a specialized oncological center. By
ensuring that the biopsy procedures are conducted with advanced imaging guidance and
that pathology evaluation is carried out by experienced experts, we can minimize the risk of
misclassication and condently select appropriate candidates for FT.
Even though availability is growing, access to
fusion-guided platforms in South America is not
yet fully widespread. Although cognitive
approaches have shown to be nearly as efcient
as software-guided fusion, signicant training in
MRI interpretation still needs to be provided to
urologists in South America.
Availability ofEnergy Modalities
The availability of multiple energy modalities for
FT is an important aspect of providing tailored
treatment. Different energy modalities, such as
high-intensity focused ultrasound (HIFU), cryotherapy, irreversible electroporation (IRE), and
laser ablation, offer distinct advantages and are
suitable for different lesion locations within the
prostate [17].

8 Acceptance andChallenges intheAdoption ofFocal Therapy forProstate Cancer inSouth America
91
Having a diverse array of energy modalities
available for FT expands the treatment options
and enhances the precision and effectiveness of
the procedure. It allows urologists to adapt their
approach based on the unique characteristics of
each patient’s prostate cancer, ensuring that the
treatment is tailored to their specic needs and
optimizing the chances of successful cancer control while preserving the quality of life.
Regarding the availability of these technologies in South America, there are a couple of specialized centers in Chile, Argentina, and Brazil
currently offering HIFU. Some in Venezuela
offer laser ablation, and one center in Argentina
offers focal cryotherapy.
Regulations andProtocols
toIncorporate New Technologies
inSouth America
The process of obtaining approval for new technologies varies signicantly across South
American countries, presenting a challenge for
the widespread adoption of FT.Each country has
its own regulatory framework and processes,
leading to a heterogeneous landscape in terms of
technology incorporation.
In countries like Chile, the government often
references the FDA and European regulatory
bodies for approval decisions. This means that
once a technology receives approval in Europe or
in the United States, it can typically be utilized in
Chile without additional regulatory hurdles. This
streamlined approach has positioned Chile as one
of the leading countries in South America and the
world for incorporating new technologies.
In contrast, countries like Brazil have regulatory institutions, like the FDA, known as
ANVISA. The approval process in Brazil requires
companies to submit extensive documentation
for validation. Although the system is well established and transparent, gaining approval can be a
lengthy process, often taking years. However,
when the technology demonstrates safety and
efcacy, companies generally receive approval.
ANVISA operates independently and aims to
avoid conicts of interest, ensuring a more reli-
able and objective evaluation. In this country, a
notable example of the challenges faced in the
adoption of FT is the case of high-intensity
focused ultrasound (HIFU). In 2011, HIFU
received approval from ANVISA, and it became
widely utilized across the country. However, in
2020, the Federal Council of Medicine (CFM),
which regulates clinical practice, classied HIFU
as an experimental treatment. Consequently, its
execution was limited to clinical studies with
dedicated funding, leading most private HIFU
programs to cease providing services to the population [18].
In Uruguay, the approval process for technologies is directly handled by the government. This
introduces a political element, as the process
relies on the decision-making of the responsible
politicians within each government. The level of
difculty faced in obtaining approval may vary
depending on specic conicts involving
companies.
In Argentina, the healthcare regulatory institution (ANMAT) has approved the use of HIFU
and cryoablation for PCa treatment. This
approval, along with the nonobjection of medical
associations, has opened the door for FT use in
clinical practice. Therefore, private institutions
interested in FT implementation do have the
opportunity to offer this treatment. However, due
to Argentina’s long story of import tampering
policies, the costs have remained high, and widespread adoption of the technique has not been
reached yet. This same obstacle is faced by, for
example, robotic surgery, with only four fully
working robotic programs (each with only one
platform) in the whole country.
The differences in regulatory processes within
each country pose signicant barriers to the
widespread adoption of FT. The varying timelines, reliance on external regulatory bodies, and
political considerations can create challenges for
companies seeking approval and delay the availability of advanced treatments in certain regions.
Harmonizing and streamlining the regulatory
processes across South American countries could
facilitate timely access to innovative technologies, improve patient outcomes, and expand
treatment options for prostate cancer.

92
R. Olivares et al.
Robotic Surgery
In most South American countries, the adoption
of robotic surgery is still in its early stages, signicantly inuencing urologists’ preferences.
Currently, many urologists are actively pursuing
opportunities to acquire robotic platforms and
undergo training and certication in robotic surgery. Their interest in robotic surgery is driven by
a desire to join the expanding wave of this technology, especially as seen in the United States
and Europe.
Urologists and administrators prioritize directing nancial resources toward robotic surgery,
both for the clear benet of their patients and to
enhance their own expertise. By investing in
robotic surgery, they aim to increase their experience, reduce the overall cost of robotic platforms,
and train a new generation of surgeons procient
in this advanced technique.
Consequently, FT might not be a top priority
for many urologists. Hospitals that currently
offer FT are mostly those with well-established
robotic surgery programs, staffed by skilled surgeons, and operate under a sustainable model.
These institutions actively seek innovative treatment options, ensuring they offer their patients
the latest advancements and maintain a competitive edge in the market.
Lack ofData Originated fromSouth
America
In a nonsystematicreview of the current literature
on FT for PCa in South America, there is a noticeable lack of data originating directly from these
countries. A search of the PubMed database,
employing terms related to focal therapy and
South American countries, yielded 356 results.
After examining the titles and abstracts, we thoroughly reviewed the full texts of 29 papers. Only
three of these papers [19–21] reported outcomes
after focal therapy, predominantly focusing on
HIFU and cryotherapy. Many of the others were
primarily reviews discussing the technology [22].
By collaborating and sharing the data that
originated from South America, we can contrib-
ute to a clearer understanding of FT adoption and
outcomes in the region. This collaboration will
help us develop evidence-based practices and
treatment guidelines tailored to our unique
patient demographics, cultural nuances, and
healthcare systems. Collaborative endeavors,
research networks, and the creation of local
shareable registries will aid data accumulation
and encourage the publication of impactful studies reecting the true nature of prostate cancer
management in South America.
Conclusion
In conclusion, while a few major centers are currently equipped with the resources for comprehensive FT application, these centers set global
standards for quality. Yet, the widespread adoption of FT in the region faces signicant challenges, encompassing cost, accessibility, and the
need for high-quality patient evaluation.
While countries like Chile, Argentina, and
Brazil have made strides in establishing FT programs, their availability remains conned to a
few select hospitals. Furthermore, these treatments are predominantly accessible to patients
with greater nancial resources. To achieve a
broader expansion of FT, integrating this treatment into the public healthcare system is vital.
Looking ahead, we are hopeful about the
future of FT in South America. We expect its utilization to rise; however, overcoming challenges
related to cost, accessibility, and quality patient
evaluation is paramount for its broader acceptance in the region. Collaborative efforts involving healthcare providers, decision-makers, and
researchers are essential in establishing sustainable FT delivery models and fostering necessary
investments in infrastructure, prociency, and
supportive policies.
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Part III
The Focal Therapy Concept: Scientic
Foundation

Understanding Tumor Biology and
Pathology: Cancer Grade, Volume,
andSpatial Location:
AsaFoundation forFocal Therapy
ArnauldVillers, JonathanOlivier,
ThomasM.Wheeler, DenisSeguier,
MahdiMottaghi, andThomasJ.Polascik
9
Introduction
Two major obstacles to the widespread application of focal therapy include (1) low accuracy of
risk classication models of post-focal therapy
local and/or metastatic recurrence of cancer foci,
(2) recognition of the multifocality of the majority of cases of prostate cancer and the likelihood
of secondary (synchronous) cancer, and (3) the
lack of specic and sensitive imaging modalities
to accurately identify the extent or contours of
intraprostatic cancer foci. In this chapter, we will
address issues on cancer foci selection of cancer
grade and volume, spatial location, patterns of
spread, and focality according to the zone of origin—as foundations for focal therapy.
A. Villers (*) · J. Olivier · D. Seguier
Univ. Lille, CHU Lille, Service Urologie, Andrologie,
Transplantation rénale, Lille, France
e-mail: Arnauld.villers@univ-lille.fr
T. M. Wheeler
Department of Pathology & Immunology, Baylor
College of Medicine, Houston, TX, USA
M. Mottaghi
Duke Cancer Institute and Duke University
Medical Center, Durham, NC, USA
T. J. Polascik
Duke Cancer Institute, Duke Prostate and Urological
Cancer Center, Durham, NC, USA
Cancer Grade andVolume
The prostate volume should no longer be a primary determinant of eligibility for FT.Other factors need to be taken into consideration, such as
the size of the prostate, the grade of the lesion,
and the boundaries and morphologic characteristics of the lesion. Hence, the importance of the
absolute volume of Gleason pattern 4 and/or 5
based on mpMRI (volume) and targeted biopsy
(% Gleason pattern 4 and/or 5) was demonstrated, which have the best accuracy to predict
the risk of metastatic recurrence after local treatment. These parameters should now be considered integral to contemporary risk models and be
used to set an upper limit for the selection of FT.
[1, 2] In the future, a modied risk model might
integrate molecular analyses from the targeted
biopsy tissue with a more rened quantitative
assessment of multiparametric MRI parameters,
each one detecting a set of different features of
this heterogeneous disease.
Index lesion as a target for ablation was
addressed in an international consensus in 2022
[3]. The expert panel reached an agreement that
all biopsy-conrmed MRI-visible lesions with
clinically signicant cancer dened as Gleason
grade group (GG) ≥2 should be used as a target
for FT (83%). At the same time, the panelists
could not achieve a consensus that the index
lesion can be dened solely by being the largest
lesion. Furthermore, there was no consensus that
© 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_9
97
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