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A. Maganty et al.
patients. Furthermore, the lack of a consistent
correlation between the level of evidence developed for FDA authorization and insurance coverage milestones might deter some entities from
investing heavily in clinical trials specic to focal
therapy. If robust clinical evidence does not guarantee quicker coverage, it might slow down the
momentum of data collection, which is critical
for newer interventions like focal therapy.
Given its potential to target malignancies with
precision, reducing collateral damage to surrounding tissues and possibly leading to fewer
complications and better patient outcomes, focal
therapy is poised to deliver high value for a subset of patients. The recent discussions around the
Transitional Coverage of Emerging Technologies
(TCET) program and similar initiatives signify
the growing acknowledgment of the need for
accelerated coverage processes [42]. If designed
adeptly, such programs could integrate valuebased metrics and align reimbursement with
patient outcomes. This approach would ensure
that patients have access to new technology, like
focal therapy, and incentivize continuous
improvement and data collection to ensure this
technology is utilized appropriately.
Conclusion
Specialty value-based care remains an essential
driver of healthcare transformation. While urology has been slow to participate in value-based
care, this remains an essential area for engagement by urologists. Given the lifetime costs of
prostate cancer, evaluating new opportunities to
improve the oncologic outcomes, quality of life
outcomes, and potential costs of care in this space
will be necessary for the future of our eld. Focal
therapy provides a potentially unique opportunity
to improve the care delivered for patients with
prostate cancer in reference to quality and cost.
However, there remain several barriers hindering
the success of these initiatives. Understanding the
fundamental of value-based care, the stakeholders
involved and the regulatory policies that inuence
the establishment of new VBC initiatives will be
critical in future initiatives including incorporating focal therapy into value-based care pathways.
Acknowledgments No funding to disclose.
Conicts of Interest None.
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The Horizon: Future ofFocal
Therapy inProstate Cancer
AlessandroMarquis andArdeshirR.Rastinehad
41
Focal therapy (FT) is an image-guided ablation of
an image-dened, biopsy-conrmed, cancerous
lesion with a safety margin surrounding the targeted lesion(s) [1]. Since the rst Annual
International Symposium on Focal Therapy (2008)
and the subsequent development of several new
technologies that included mpMRI of the prostate,
fusion biopsy, ablation platforms, and nuclear
medicine tracers have transformed the prostate
cancer care cycle. These advances have led to
increasing interest in FT over the past 15years,
culminating in 2019 with the founding of the Focal
Therapy Society by Drs Thomas Polascik,
Ardeshir Rastinehad, Jean De La Rosette, Rafael
Sanchez-Salas, and the initial Board of Directors.
The growth in the eld has been substantial with
the number of procedures performed between
2015 and 2020 more than doubled that of the previous 20years [2]. In awareness of the difculty of
proceeding with randomized clinical trials, the
Focal Therapy Society and other sites have created
large multiinstitutional registries to start collecting
high- quality, real-world data on oncological and
genitourinary functional outcomes, revealing that
FT is a safe and effective option for the management of localized prostate cancer (PCa) and can
compete with conventional radical therapies in
well-selected patients [3, 4].
Despite the progressive afrmation of recent
years, FT still has a considerable margin for
improvement. In a world aspiring to the early
detection of PCa through a tissue-free diagnosis
based on biomarkers, high-resolution imaging,
and articial intelligence (AI) algorithms, FT
should continue to challenge the dogma and have
the ambition to become the new standard of care
for appropriate patients. To reach this goal, future
advancements must address the main steps of FT,
from the patient selection process to the posttreatment follow-up, passing through the treatment planning and delivery.
Patient Selection
A. Marquis
Northwell Health System, Smith Institute for Urology
at Lenox Hill, Lake Success, NY, USA
Department of Surgical Sciences, Division of
Urology, Molinette Hospital and University of Turin,
Turin, Italy
A. R. Rastinehad (*)
Smith Institute for Urology at Lenox Hill, Northwell
Health, Lake Success, New York, NY, USA
© 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_41
Patient selection is the key aspect of FT.A suboptimal selection process almost inevitably results
in treatment failure. Current milestones of this
step lie in PSA, multiparametric (mp) MRI, and
prostate biopsy, which are combined to identify
the ideal candidate for FT.
PSA is the primary biomarker of PCa. Despite
being benecial for the early detection, its ability
489
490
A. Marquis and A. R. Rastinehad
in the risk stratication is limited. In FT, PSA is
mainly used as an exclusion criterion when it is
above a certain threshold, depending on different
FT protocols. To overcome the limitations of
PSA, other promising serum, urine, and genomic
biomarkers have been introduced in the diagnostic evaluation of PCa. Still, their role has not been
validated in the setting of FT. Nevertheless, the
potential of biomarkers in FT appears signicant
since it could help discriminate patients with
low-risk PCa at higher risk of progression who
deserved to be cured (cancer control) with FT
rather than placed on active surveillance.
Similarly, biomarkers may help discriminate
those with intermediate- (or high-) risk PCa at
lower risk of progression who can be safely
treated with FT rather than a radical treatment.
Therefore, future efforts should be directed in
this eld of research to develop risk-stratication
models incorporating novel PCa biomarkers with
clinical and radiological parameters to improve
PCa detection and tailor the best treatment
options for each patient.
High-resolution imaging able to characterize
the exact location and extension of clinically signicant PCa within the prostate gland and its
relationship with the external sphincter, urethra,
rectum, bladder and neurovascular bundle is a
priority in selecting a patient for FT.Today, this
role is supported by the 3T mpMRI.While it is
by far the best available imaging for local staging
of PCa, its positive predictive value is low, with
six out of ten suspected lesions testing negative
for csPCa [5], and its negative predictive value is
largely dependent on PCa prevalence and tumoral
volume and grade [6, 7]. This implies the need to
histologically conrm mpMRI-visible lesions to
exclude false-positive cases and combine systematic sampling to obtain reliable local staging and
avoid false-negative cases. However, 7T mpMRI
has been conceived to increase the diagnostic
accuracy of mpMRI. However, while increased
magnet strength can offer improved delineation
of prostate anatomy, it can also amplify artifacts.
Indeed, today, no clear benet has been observed
in the clinical detection of primary PCa compared to 3T protocols, which are faster and more
readily available [8]. PSMA PET-MRI is an
emerging option in the eld of PCa. It proved to
be of greater diagnostic value in locating PCa
than mpMRI or PET imaging alone, with a highrisk lesion contrast and excellent consistency in
lesion detection [9]. Despite PET imaging not
being widely used today, its future role in optimizing the selection process of FT is extremely
promising. Current technologies can obviate the
need for PSMA PET MRI machines and the additional cost by utilizing coregistration software
that is able to fuse the PSMA-PETCT and
mpMRI of the prostate to aid in the assessment
and sampling of suspicious tissue.
At present, it is not clear that AI can detect and
histologically grade PCa at a performance level
comparable to that of international experts in
prostate pathology [10], while its ability to accurately read mpMRI, which is challenging for its
intrinsic multiparametric nature, is still maturing.
Some machine and deep learning studies have
already reported promising but highly variable
results [11]. However, considering its vast potential and great enthusiasm for this new technology,
it is likely that soon, AI models combining clinical parameters, biomarkers, and high-resolution
imaging will play a central role in all steps of PCa
management, including improving the eligibility
process for FT.
Treatment Planning andDelivery
Accurate pretreatment planning is essential for
FT.In this step, the treatment area including the
index lesion and a surrounding safety margin is
rst identied on mpMRI.It is then delineated on
real-time US, MRI/US fusion imaging or MRI
depending on the treatment modality. After verifying the noninvolvement of the anatomical
structures in the area of treatment, FT can be carried out according to the type of energy used.
The efcacy of FT is highly dependent on the
ability of mpMRI to correctly distinguish the
limit between pathologic and healthy tissue.
Unfortunately, mpMRI tends to underestimate up
to half of the volume of the index lesion when
41 The Horizon: Future ofFocal Therapy inProstate Cancer
491
compared to radical prostatectomy [12]. This
explains the need for a surrounding safety margin
to guarantee adequate oncological outcomes, but
these results are dependent on the quality of
mpMRI which can vary from institution to institution. In this context, a future shift toward
higher-resolution imaging, for example, the
PSMA PET-MRI discussed above, could lead to
a more precise characterization of the boundaries
of the index lesion and a decrease in the width of
the safety margin, potentially improving functional outcomes and complications of FT.
Identifying the target lesion on real-time US
images is another crucial step in FT.Although it
can be performed through a cognitive, fusion, or
in-bore approach, several consensuses have preferred the fusion method, which is accurate and
affordable [1]. However, despite being increasingly adopted, this approach is still underused.
Future efforts should encourage the adoption of
this method at the expense of the cognitive one,
which can have several limitations in inexperienced hands.
Manual segmentation is needed for a fusionbased FT and is time-consuming and susceptible
to human error since it requires appropriate skills
in mpMRI reading. AI-based automatic and
semiautomatic segmentation algorithms have
been tested with promising results and are
expected to become the dominant method [13].
Implementing this technology in everyday clinical practice could potentially increase the quality
of segmentation and speed up the procedure.
Nonetheless, AI should not be intended as an
alternative to the radiologist, with whom it is
always good practice to have an ongoing
exchange of views.
Several technologies exist for FT, with different energies and delivery approaches. In the
absence of comparative studies, they all have led
to similar promising results. Ideally, a FT program should offer patients more than one technology to widen the treatment strategy and tailor
the best therapeutic option for each patient. When
possible, performing FT using local anesthesia in
an outpatient setting would reduce perioperative
anesthesia-related risks and costs.
Posttreatment Follow-Up
Today, FT requires an intense follow-up involving the close monitoring of PSA and a preestablished “by protocol” execution of a
mpMRI-targeted prostate biopsy to exclude disease recurrence [1]. Despite being necessary for
patients’ safety, all this can negatively impact
their quality of life. Future, patient-friendly strategies should be considered to lessen the frequency of visits and invasive examinations.
PSA has an important prognostic ability in
whole gland radical treatments, such as radical
prostatectomy or radiotherapy. In contrast, after
FT, its role is uncertain because, although a nonspecic decrease is expected, the untreated portion of the gland continues to produce PSA. In
this regard, serum, and urine biomarkers, could
represent a promising strategy to selectively
identify those patients who need further invasive
investigations after FT.However, research investigating the use of biomarkers in FT is lacking.
Current FT protocols involve a mpMRI and a
follow-up prostate biopsy generally within the
rst year after FT.However, the cytoarchitectural
changes and tissue retraction consequent to FT
can complicate the mpMRI evaluation, while the
presence of scar tissue can make the prostate
biopsy technically challenging. To overcome
these limitations, higher-resolution imaging,
such as PSMA PET-MRI or PET-CT, could be
introduced in FT protocols to increase diagnostic
accuracy and differentiate patients who need a
prostate biopsy “by trigger” of imaging from
those who can be followed-up conservatively.
Conclusions
Today, abundant studies using different energies
and techniques show that FT in well-selected
patients is safe and effective. Despite that, FT
still has great potential for improvement. In general, the development of new biomarkers, highresolution imaging, and AI algorithms could, in
the future, revolutionize all the steps of FT, especially in the patient selection process. The
492
A. Marquis and A. R. Rastinehad
improvement of available technologies and the
widespread adoption of well-structured FT programs could further improve FT outcomes and
offer a tailored treatment option for patients. The
post-FT follow-up could become less invasive
and more patient-friendly, with fewer visits and
exams having a positive impact on the patient’s
QoL. By investing time and resources in these
current needs and future prospects, the next generation of urologists will have the opportunity to
make FT the new standard of care.
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in MRI-based radiomics and articial intelligence
for prostate cancer: a comprehensive review and
future prospects. Cancers (Basel). 2023;15(15):3839.
Published 2023 Jul 28. https://doi.org/10.3390/
cancers15153839.
Index
A
Aberrant microvascular network, 118
Ablation, 4
for focal therapy, 8, 9
pattern, 329
techniques, 293
therapies, 26
principles of
cryoablation, 28, 29
radiofrequency ablation, 30–32
Acapatamab, 120
Acoustic radiation force impulse
(ARFI) imaging, 172
Active surveillance (AS), 4, 26, 63
in East and Southeast Asia, 80, 81
Europe, adherence in, 74
Europe and EAU Guidelines position, protocols in,
64–66
and focal therapy, 55–57, 82
literature on, 80
MRI, outcomes after, 127
prostate magnetic resonance
imaging, 139, 140
shared decision-making, in Asia, 82, 83
Adenomatous polyposis coli (APC), 236
Affordable Care Act, 477
American Urological Association (AUA), 25
Androgen manipulation, TME, 119
Anterior Hockey-Stick Ablation
(Anterior Three-Fourth), 277
Anterior partial prostatectomy, 287
Anterior prostate cancer (APC),
281, 282, 284, 285, 288
Antibiotic prophylaxis, 301
ANVISA, 91
Apoptosis, 120
Apparent diffusion coefcient (ADC), 123, 424
Artemis fusion biopsy platform, 201–204
Articial intelligence (AI), 58, 342, 490, 491
Asian Prostate Cancer (A-CAP), 80
Aspirin, 120
Atrophy, 456
Australian cost analysis, 215
B
Benign prostatic hyperplasia (BPH), 375
Biochemical recurrence (BCR), 184, 451, 452
BioJet platform, 203
Biomarkers, 82, 111
BiopSee platform, 202
Biopsy, 7
core quality for diagnosis, 211, 256, 257
needle penetration, 212
Biopsy-based genomic assays
ConrmMDX, 113
Decipher test, 112
focal therapy, critical reections, 113, 114
limitations, 114
Oncotype DX, 112, 113
Prolaris test, 113
Biparametric MRI (bpMRI), 138
Bipolar radio frequency ablation (bRFA), 443
B-mode and color Doppler images of the prostate, 173
B-mode and contrast-enhanced ultrasound images of
prostate, 173
B-mode ultrasound, 189
Bowel toxicity, 435
BRCA1, 107
Breast and prostate cancers (BCa), 15
Breast cancer
focal therapy, 15, 16, 19
index lesion theory, 19, 20
metastatic progression of, 18
untreated clinically signicant cancer, 20
BxChip™, 259
C
CADMUS trial, 175
Cancer-associated broblasts (CAF), 118
Cancer grade and volume, 97, 98
assessing radical prostatectomy specimens, 98
FT series, outcomes of, 98
selection criteria, validation of, 98
spatial distribution of cancers, 98
zone of origin and volume, prevalence
according to, 98, 99
© The Editor(s) (if applicable) and 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
493
494
Index
Cancer laterality and focality, 99, 100
Cancer mapping, 6
Cancer-specic survival (CSS), 16, 25
Cancer volume, 264
Castration-resistant prostate cancers (CRPCs), 107
Cell cycle progression (CCP) genes, 113
Center for Medicare and Medicaid Innovation (CMMI),
477
Chemotherapy, 6, 18
Chimeric antigen receptor T-cell (CAR-T) therapy, 120,
121
Chronic inammation, 119
Cialis, 13
Clavien-Dindo system, 306
classication, 445
Clavien-Dindo AEs scale, 304
Clinically signicant PCa (csPCa), 135, 212–214
Clinical risk categories, 267
Clinical signicance, 6, 108
Cognitive fusion TR biopsy, 190, 191, 214
Collagen, 118
Common Terminology Criteria for Adverse Events
(CTCAE), 445
Complete muscle relaxation, 298
Comprehensive Care for Joint Replacement (CJR)
Model, 478
Condition-based bundled payment, 482
CONFIRM trial, 248
ConrmMDx test, 113, 236
Continence, 59
Contrast-enhanced transrectal ultrasound (CeTRUS),
393, 394
Contrast-enhanced ultrasound (CEUS) imaging of the
prostate, 173
Core fragmentation, submission, 257
Core length, 256
COX-2, 120
Cryoablation (CA), 25, 32, 33, 119, 276, 297, 305, 308
freeze-thaw cycles and treatment duration, 29
mechanism of action, 28, 29
placement, 331
using MR/US fusion imaging, 306
versus radiofrequency ablation, 39
treatment temperature, 29
Cryoprobes, 331
Cryotherapy, 52, 73, 91, 266, 285, 293, 328, 330
CTLA4, 120
Cultural protective factors, 80
Cystoprostatectomy, 98–100
Cytokines, 118
D
Damage-associated molecular patterns (DAMP), 118
Decipher test, 112, 125, 236, 267
Decipher genomic classier (GC), 125
Decision-making process, 48
Deep neural network (DNN), 175
Delphi method, 447
DeTeCT trial, 244
Digital rectal examination (DRE), 136
Direct MRI-guided biopsy, 190
Direct TP ablative procedures, 203
Disease progression, 79
Distal or anterior lesions, 267
Docetaxel, 120, 121
Dosiomic-based machine learning model, 324
Double crossover of cores, 258
Dual-tracer approach of PSMA and GRPR PET-targeted
biopsy, 246
DynaLOC software, 409
Dynamic contrast-enhanced (DCE), 123
E
EAU Section of Urological Imaging (ESUI) consensus
meeting, 141
EAU Young Academic Urologists (YAU), 73
Elastography, 169
Electromagnetic tracking, 197, 199
Endocrine therapy, 18
Energy modalities, availability of, 90, 91
Episode-based payment model, 482
Enhanced Recovery After Surgery (ERAS) protocol, 301
Erectile function, 13, 444
Europe
adherence in, 74
protocols in, 66–72
European active surveillance protocols, 65
ExosomeDx (ExoDx) tests, 235
Expanded Prostate Cancer Index Composite (EPIC), 444,
445
External beam radiotherapy (ERT), 322
Extracellular matrix (ECM), 117
Extra-prostatic extension (EPE), 102, 140, 141, 267
Extreme apical diseases, 266
F
Failure-free survival rate, 17
Federal Council of Medicine (CFM), 91
Fibroblasts, ECM, 118
Field generator (electromagnetic tracker), 159
Fluorine-18 (18F)-radiolabeled PSMA
ligands, 244, 245
Focal ablation approaches, 181, 276, 329
image-guided targeted ablation of index lesion, 329
therapies for SRM, 25
Focal brachytherapy, 276, 442
Focal cryoablation
patterns, 329
procedure, 331
Focal cryotherapy (FC), 330, 332–338
advancements
cryosurgery, 342
imaging, 339
multidisciplinary efforts, 342
assessment of lower urinary tract function, 339
mpMRI, 425, 426
Index
495
post treatment pad-free continence and potency rates,
332
variability, 339
Focal external beam radiotherapy (ERT), 322, 323
Focal HDR interventional radiotherapy for prostate
cancer, 320
Focality, cancer, 99
Focal laser ablation (FLA), 17, 52, 66, 276, 442
mpMRI, 423–425
using magnetic resonance-ultrasound fusion, 298
Focal Laser Ablation of Prostate Cancer: An Ofce
Procedure, 298
Focal LDR interventional radiotherapy for prostate
cancer, 321–322
Focal radiotherapy in prostate cancer, 323
Focal salvage cryotherapy, 339–341
Focal therapy (FT), 3, 5–7, 15, 49, 63, 79, 157, 263
ablative technology, types, 8, 9
active surveillance and, 55–57
adoption, acceptance and challenges in
awareness and knowledge among healthcare
professionals, 87, 88
data originated, lack of, 92
energy modalities, availability, 90, 91
healthcare system, patient access, 88
patient preferences and shared decision-making,
88, 89
patients suitable, volume of, 89
prostate MRI, 89, 90
regulations and protocols, 91
risk stratication, 90
robotic surgery, 92
after treatment, 12
for anterior cancer, 281
AS/radical treatment, 57–59
basis of, 179
BCR, 451, 452
breast cancer, 15, 16
bRFA, 443
candidates, 19
clinically insignicant tumor, 455
as continuous risk function, 268
cryotherapy, 442
during treatment process, 9, 11
in East and Southeast Asia, 81, 82
Europe
adherence, 74
available protocols in, 66–72
perspective, 73
FLA, 442
focal brachytherapy, 442
follow-up protocols, 452
functional outcomes, 12, 13
erectile function, 444
physical/mental outcomes, 445, 446
safety, 445
urinary function, 444
guidelines, 449
HIFU, 442
index lesion, 180
IRE, 442
localization, 449
microwave ablation, 443
minimally invasive treatment, 6
molecular biomarkers, 451
monitoring, 446, 447
monoclonal vs. multiclonal hypotheses and impact,
107, 108
mpMRI, 489
MRI after, 145, 146
multifocality and lesion visibility, 180
non-treated area, 464, 465
oncologic/pathologic outcome, 455
outcomes and post-treatment surveillance, 13, 14
PAE, 443
partial prostatectomy, 443
patient candidacy, 180
patient-reported outcomes, 446
patient selection, 489, 490
PDT, 443
posttreatment follow-up, 491
prostate cancer, 16–18, 51, 52
PSA
density, 450, 451
follow-up, 449
in-eld and out-of-eld recurrences, 450
nadir, 450
percentage of reduction, 450
velocity and doubling time, 451 (see also
Reimbursement models)
quality of life, 441
recommendations, 465, 466
role of, 453
safety margin, 101
for salvage treatment, 6
diagnosis of recurrence, 469, 470
HIFU, 469
issues, 470
modalities, 470
radical prostatectomy, 471, 472
radiotherapy, 472, 473
repeat ablation, 470, 471
surveillance, 470
selection criteria, 268
shared decision-making, in Asia, 82, 83
staging imaging
optimal oncologic control, 181
patient candidacy, 181
treated area
HIFU, 459, 460
histopathologic changes, 456, 457
IMT, 463, 464
neoplastic and non-neoplastic tissue, 456
post-brachytherapy, 456–458
post cryotherapy treatment, 460, 461
post IRE, 463
post laser ablation, 461, 462
post photodynamic therapy, 462, 463
radiofrequency ablation, 464
treatment planning and delivery, 490, 491