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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5209_Библиотеки_им_академика_М_И_Перельмана.pdf
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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

360
J. L. Chin et al.
point is dened as the proportion of patients free
from treatment failure (i.e., delivery of any additional intervention therapy for prostate cancer,
metastasis, or prostate cancer-specic death).
There are several secondary safety endpoints,
patient-reported quality of life scores, secondary
efcacy measures as well as a planned economic
analysis. Randomization is a 2:1 ratio in favor of
TULSA over radical prostatectomy.
A prospective clinical safety and efcacy
study of MR-visible lesion-targeted TULSA is
also underway in Finland. Primary outcome measures are severe adverse event-free survival at 3
months and disease-free survival at 12 months.
Secondary outcome measures include urinary
continence status, erectile function status, radiological failure-free survival (MR Likert suspicion
level >4), and ablation failure-free survival.
Patient Selection andTULSASpecic Exclusion Criteria
Patient Selection
The majority of patients treated with TULSA to
date around the world have been those with primary low to intermediate-risk prostate cancer,
although small numbers of men with high-risk
disease have also been treated as the clinical
experience and comfort with the TULSA procedure increases [7, 11, 14]. A subset of patients
have also been treated for BPH symptoms alone
[12], as well as in the salvage setting after prior
radiation or focal therapy [10, 14]. These different studies highlight the breadth of patients that
can be treated with TULSA.
In the primary prostate cancer setting, patient
selection for TULSA is similar to other focal ablative methods, as touched upon in this book, and
involves characterization of the disease location
and burden with prostate biopsy and imaging. The
traditional considerations of the patient’s overall
health, life expectancy, and existing urinary and
sexual function status all play a role in patient
selection, as well as the expected oncologic outcomes of focal therapy compared to radical therapy
for prostate cancer [15]. Given the transurethral
location of the TULSA UA, the ability of the robot-
ically driven arm to revolve for 360° treatment, and
the treatment range of ~3 cm from the device,
patients who may have been ineligible for other
focal ablative energy sources due to disease volume or lesion location could be eligible for
TULSA.For instance, anterior lesions that might
be challenging to reach with transrectal high-frequency focused ultrasound (HIFU) due to lesion
distance from the rectal wall are amenable for treatment with TULSA if they are within 3cm of the
urethra. Bilateral disease requires more extensive
or near whole gland ablation that might present
challenges for irreversible electroporation (IRE), or
focal laser ablation (FLA) can also be good candidates for treatment with TULSA. Additionally,
given early trial data demonstrating efcacy with
treatment of BPH [12], a particular benet of
TULSA has been the concurrent treatment of BPH
during ablation of prostate cancer, with signicant
improvement in voiding symptoms 3–6 months
after treatment in our patients. As such, evaluation
of urinary symptoms with IPSS and noninvasive
uroow can help identify patients who may benet
from this type of treatment approach.
Patient selection in the salvage setting depends
upon their prior form of treatment for prostate cancer. For patients with recurrent disease after radiation or prior ablative therapy, careful assessment of
anatomic changes due to treatment, presence of
ducial markers or other implants, and disease location in relationship to these factors plays an important role in determining whether a patient is a good
candidate for salvage TULSA.Baseline assessment
of urinary and sexual function and determination of
the patient’s goals of care in the salvage setting are
important given the higher risk of morbidity compared to primary treatment. While neither the TACT
trial [7] nor the current randomized CAPTAIN trial
(NCT05027477) for primary prostate cancer treatment includes high-risk prostate cancer patients, the
decrease in the number of treatment options in the
salvage setting and associated morbidity with salvage prostatectomy with recurrent disease after
radiation suggest a role for broadening patient
selection criteria in this setting. This is supported by
a small pilot study from Finland, which demonstrated safety and feasibility in 11 patients undergoing salvage TULSA, of which 5 out of 11 patients
had GG4 or GG5 prostate cancer [10].

30 Role ofTransurethral Ultrasound Ablation (TULSA) inProstate Cancer Focal Therapy
361
TULSA-Specic Exclusions Criteria
While TULSA enables treatment for many
patients, there are some strict exclusion criteria.
Patients with contraindications for MRI, including cardiac pacemakers, debrillators, intracranial clips, and other MRI-incompatible implants,
are not able to undergo TULSA.Patients with
prior history of urethral strictures or anal stenosis need to undergo evaluation for whether they
are able to accommodate passage of the 19-Fr
UA or rectal ECD to be eligible for treatment.
Patients with hip replacement surgery or metal
in the pelvic area can also present challenges
with visualization and treatment of ipsilateral
lesions, and while not absolute contraindications, may require further evaluation to see if
their particular lesions are amenable for TULSA
(see next section for further details). Finally,
patients with seminal vesicle invasion, gross
extraprostatic disease, tumors over 3cm away
from the urethra, and large calcications or
cysts between the urethra and treatment region
should be excluded from treatment. For select
patients with lesion margins over 3cm from the
urethra that would normally be out of treatment
range for TULSA, neoadjuvant treatment with
5-alpha-reductase inhibitors may help decrease
the size of the prostate sufciently to allow for
successful ablation, especially in combination
with the recently FDA-approved Thermal Boost
TULSA AI module [16].
TULSA-Specic Imaging
andTargeting forFocal Therapy
Preoperative Imaging Planning
Imaging plays an essential role in pre-procedure
planning and intraoperative decision-making for
clinicians performing TULSA. Preoperative
images provide information on the characteristics
of the prostate gland (i.e., size and anatomic components) and the lesion of interest (i.e., size, focality, and location), as well as other notable features
such as the presence of calcications, implants,
ducials, or brachytherapy seeds that may affect
the feasibility of the procedure. Importantly, PSMA
PET/CT can also be used to assess for metastatic
disease prior to proceeding with focal therapy.
Magnetic resonance imaging can give accurate
measurements of prostate size, as well as prostatic
anatomy which may be important to note during
the procedure. Studies have demonstrated the
ability of MRI to accurately detect clinically signicant prostate cancer while excluding clinically
insignicant prostate cancer [17]. MRI can, therefore, provide clinicians with valuable information
on the size and location of the lesion(s) of interest
(LOI), which can help determine the feasibility
and technique employment during TULSA.The
TULSA-Pro device is a transurethral instrument
that uses ultrasound to ablate prostate tissue with
a goal temperature of 55*C, a temperature that is
100% lethal to epithelial cells. The treatment
range of the TULSA-Pro device is approximately
3 cm, and a lesion of interest >3cm from the urethra on MRI may therefore be inadequately
ablated. Similarly, a disease that demonstrates
evidence of extra- prostatic extension on imaging
is likely to be out of the treatment range for the
TULSA device, and TULSA may not be effective.
Data have shown cell necrosis to occur up to
3mm from the device, beyond which no visible
damage to cells occurs [18]. It is therefore recommended to conrm that the LOI is greater than
3mm away from the prostatic urethra and external urinary sphincter to minimize adverse effects
that are a result of energy dispersion that may
negatively impact critical structures.
Prostatic calcications are common in men
with prostate cancer and have been shown to limit
therapeutic ultrasound treatment [19, 20]. Based
on clinical experience, calcications greater than
3mm in the target ablation area appear to interfere with the ablation pattern and efcacy.
Similarly, implants such as ducials have been
shown to decrease the focal intensity of the ultrasound and distort the ultrasound beam, which
may lead to over- or undertreatment of some areas
[21]. One study has shown that the type of ducial
likely affects the impact on MRI interference,
suggesting gold ducials have negligible effect on
MRI quality [22]. Implants from prior Urolift procedures also lead to imaging interference, which
may inhibit accurate lesion identication targeting and ablation. Figure30.3 shows the position

362
Fig. 30.3 “Urolift” implants visualized on CT (left) causing eld defect on MRI (right)
of Urolift implants on CT, which are also seen
causing a rim defect on MRI. Identifying these
patient factors prior to the procedure will help
determine if TULSA can be performed and help
facilitate intraoperative technique.
MR thermometry can be used in the preoperative setting to screen select patients for potential
imaging interference caused by preexisting
implants. Implants may produce imaging “noise”
that inhibits a clinician’s technical ability to perform TULSA or impacts ablation. Data have
shown that MRI radiofrequency can lead to the
heating of metal implants, but this seems to be
less of an issue during TULSA ablation as our
goal is to heat the tissue with ultrasound [23].
Implants of particular interest in the prostate cancer population are ducials. There is a noted halo
effect around ducials, which impairs tempera-
Fig. 30.4 Shows the halo effect of ducials on MRI
ture mapping and may lead to an indeterminate or
inaccurate degree of ablation of these areas.
Figure 30.4 shows a ducial-associated halo
defect on pretreatment MR images, and Fig.30.5
shows correlating abnormalities on MR thermometry images, with the thermometry data
overestimating the temperature of the tissue in
the area of the implant. Generally, TULSA can
treat lesions of interest that are contralateral to
the implant. Clinicians can also consider using
1.5 T MRI instead of 3 T MRI to try and minimize imaging artifacts during the procedure;
however, this may impair the ability to detect
lesions on follow-up imaging. MR thermometry
can also be used for pretreatment planning in the
setting of implants such as hip replacements to
identify the degree of imaging interference produced by the extra-prostatic implant and its
potential effect on the feasibility of
TULSA. Figure 30.6 shows pretreatment MRI
images with shadowing from the left hip implant
encroaching on the prostate. However, Fig. 30.7
shows overall insignicant interference from the
implant on treatment planning images obtained
during the procedure.
J. L. Chin et al.

30 Role ofTransurethral Ultrasound Ablation (TULSA) inProstate Cancer Focal Therapy
Fig. 30.5 Shows correlating ducial interference seen on intra-procedure imaging
Fig. 30.6 Imaging interference from left
hip implants results in dark shadowing in
the left pelvis and surrounding the left
side of the prostate
363
Fig. 30.7 No signicant shadowing from a left hip implant was noted on pretreatment MRI and intra-procedure
imaging

364
J. L. Chin et al.
Biopsy Targeting andNeed
forBiopsy-Imaging Concordance
Biopsy data prior to TULSA can be obtained in a
variety of ways. Targeted biopsy results based on
an MRI of the prostate can either be performed
with a transperineal or transrectal approach.
In-bore or fusion biopsies can be utilized to
obtain necessary pathology. These techniques are
thoroughly reviewed in a previous chapter. The
importance of pre-TULSA pathology is ensuring
biopsy-image concordance: conrmation that the
target lesion for ablation coincides with the designated pathology. Some patients may present
with systematic biopsy data without targeted
cores of the target lesion. Clinicians should pursue additional biopsies as necessary to verify
lesion(s) of interest and to identify the pathology
of any additional suspicious areas within the
gland. Pursuing an in-bore or targeted biopsy of
the lesion of interest may be sufcient after a systematic biopsy, as the rest of the gland has been
previously sampled. Adding targeted cores to a
patient’s biopsy data may also increase their ability to pursue clinical trials, as most focal trials
require some assessment of the degree of cancer
within the targeted lesion(s) as part of the inclusion criteria.
Intraoperative Considerations
Prior to the TULSA procedure, physicians should
review available MRI images and reports, biopsy
report data, and conrm MRI safety checklists.
The entire TULSA procedure is performed within
an MRI, and we list important technical considerations below.
The TULSA-PRO UA is inserted into the urethra over a wire and can be adjusted to appropriately target the lesion of interest (LOI). Clinicians
should pay careful attention when inserting the
device over the wire, particularly when feeding
the wire into the coudé tip of the device. A superstiff wire is often used, and if the wire is not fed
along the curve of the device tip, the wire can
perforate the channel and potentially lead to
leakage of uid from the device into the bladder
during the procedure. Special attention is needed
to ensure no damage to the device occurs during
device insertion. If there is any concern during
device insertion, clinicians should consider performing a cystoscopy with catheter placement
over a wire to ensure the catheter is in an appropriate position and not in a false passage. The UA
can be manually adjusted to facilitate ablation
success during the procedure. For anterior
lesions, the clinician should angle the probe
downward to stretch the anterior prostate and
increase the distance between the pubic bone and
the anterior prostate border. Additionally, if a clinician is working with a large gland, the gland
can be compressed with the device to keep the
prostate borders within the 3 cm treatment distance. Adjustments can also be made if one
encounters prostate calcications or implants
using susceptibility-weighted imaging (SWI)
sequences and adjusting the urethral device to
minimize their impact on ablation and targeting.
For example, one can position the calcication
between transducer elements to minimize the
degree of ultrasound interference.
If there is too much movement during the procedure, either from enteric organs or from patient
activity, TULSA cannot be accurately performed.
Movement leads to artifacts on the real-time MRI
thermometry, and the TULSA-PRO system will
enter an automatic 20-min shut-down and cooldown mode to recalibrate and ensure accurate
temperature mapping. During cool-down, images
will be recaptured, and treatment borders should
be reassessed to ensure the movement has not
changed the desired ablation zone. It is therefore
important to maintain consistent patient paralysis
with the assistance of the anesthesia team to minimize patient motion. Glucagon, a gastrointestinal antispasmodic, is also routinely administered
intraoperatively to help decrease rectal wall
motion [4].
Another important consideration is the phenomenon of gland swelling during TULSA.The
gland will swell during heating, which can impact
margins obtained during the procedure
(Fig. 30.8). Clinicians must dynamically adjust
margins based on the degree of swelling visualized intraoperatively to achieve satisfactory mar-

30 Role ofTransurethral Ultrasound Ablation (TULSA) inProstate Cancer Focal Therapy
Fig. 30.8 Prostate gland swelling seen during TULSA and changes to prostate boundaries before and during
treatment
365
gins. This can be done between sweeps to
accurately reassess prostate borders and margins.
Decadron can be taken the night prior to the pro-
Clinical Examples ofFocal TULSA
Procedures
cedure and be given in pre-op to help limit gland
swelling.
Real-time MR thermometry uses thermal temperature mapping to allow for real-time lesion
detection and ablation. Thermometry data allow
physicians to make dynamic changes to their
ablation zone based on temperature response and
feedback of the tissue. This also allows physicians to not only actively adjust the extent or borders of ablation to achieve desired margins, but
also make adjustments during the procedures that
would allow for sparing critical structures such as
ejaculatory ducts and sphincter. Physicians will
select a 3 mm safety margin around the outer
boundary of the prostate, which theoretically represents the furthest extent of tissue damage during ablation [8]. Dening these borders may help
to decrease the thermal effect on these critical
structures. Importantly, clinicians should pay
careful attention to the homogeneity of the gland
on MR imaging. The water content of the gland
affects the propagation of energy during ablation
and may impact surrounding structures. One
technique that may be employed to minimize
During the pre-procedure planning phase, clinicians will determine the extent of ablation needed
to treat the lesion or lesions of interest. The pattern of ablation may be determined based on
tumor location, tumor size, and other patientspecic gland characteristics (i.e., presence of
BPH or prior urologic procedures). Ablation
types include targeted ablation, hemi-ablation, or
whole-gland ablation. Targeted ablation focuses
on the lesion of interest. Hemi-ablation ablates
half the gland, which may refer to laterality (left
or right) or anterior-posterior regions. Wholegland ablative techniques ablate the entire gland.
In men with underlying bothersome lower urinary tract symptoms (LUTS), ablation of the
transition zone may also be pursued to help treat
BPH symptoms.
We present here two cases: one patient who
underwent TULSA as primary treatment for his
prostate cancer and one patient who underwent
TULSA as salvage treatment in the setting of
prostate cancer recurrence after radiation
therapy.
peripheral toxicity is urethral line cooling. This
becomes particularly relevant in the setting of
apical lesions. Cooling the urethral applicator
lines with ice will lower the temperature of the
TULSA asPrimary Treatment
ofProstate Cancer
tissue immediately adjacent to the urethral applicator, helping to increase the tissue gradient and
allow for further ablation in areas that may be
more at risk for adverse effects.
For a patient presenting with newly diagnosed
prostate cancer with no prior treatment, clinicians
should consider the patient’s disease characteris-

366
a
b
J. L. Chin et al.
tics, as well as baseline urologic symptoms (urinary and erectile function), to determine if
TULSA should be offered. Erectile function and
LUTS should be assessed with standardized
symptom scores (i.e., IIEF or IPSS), and quality
of life measures should be obtained. Noninvasive
in-ofce testing such as UroFlow with post-void
residual or home assessments with ProudP™ can
provide clinicians with valuable baseline data
that may be used as a comparison to assess postprocedure urinary symptoms. PSA, MRI, and
biopsy data should be available and reviewed by
clinicians prior to the procedure to ensure
TULSA’s indication and imaging biopsy concordance. MRI safety checklists should be followed,
especially if a patient has implants elsewhere in
the body. Prior to the procedure, clinicians should
engage in thorough counseling with patients
regarding the steps of the procedure, potential
adverse effects, and aspects of recovery. Specic
adverse events such as pain, bleeding, infection,
urinary incontinence, erectile dysfunction, stula, decreased ejaculatory volume, and the need
for a catheter should be discussed. Counseling
should also include the potential adverse effects
associated with pursuing alternative treatments
such as surgery or radiation instead of
TULSA.Importantly, clinicians should relay that
should a patient experience a recurrence of disease after focal treatment, there are treatment
options such as retreatment with focal therapy,
surgery, or radiation available to gain cancer
control.
A 60-year-old male presents with a PSA of
11.6 ng/mL.MRI of the prostate shows a 53 mL
gland with a PI-RADS 5 lesion in the right anterior transition zone. Prostate biopsy showed 5/14
cores positive for grade group 2 disease at the
right apex and the right mid gland. At baseline,
the patient has normal erectile function and
moderate LUTS based on AUASS. MRI planning images were obtained of the anterior ablation zone, which include the lesion of interest
and transition zone with sparing of the apical
sphincter, neurovascular bundles, and bladder
neck (Fig.30.9a). Treatment images show good
coverage of the planned treatment zone and the
maximum temperature reached within the ablation zone without signicant extension of heat
outside the treatment margin (Fig. 30.9b).
Posttreatment contrast-enhanced MRI obtained
at the conclusion of treatment demonstrates a
corresponding ablation cavity for the treatment
plan (Fig.30.9c), with an anticipated 1–2mm of
delayed cell kill at the margin based on preclinical data [5].
c
Fig. 30.9 (a) Planning images of anterior ablation
including lesion and transition zone with sparing of apical
sphincter, neurovascular bundles, and bladder neck. (b)
Maximum temperature map demonstrating achievement
of target temperature in the ablation zone. (c) Posttreatment
contrast-enhanced MRI with corresponding ablation cavity for the treatment plan

30 Role ofTransurethral Ultrasound Ablation (TULSA) inProstate Cancer Focal Therapy
11 patients with radio-recurrent disease, with 73%
of patients being cancer-free at 1 year [10]. An
important consideration of this population includes
the presence of ducial markers or brachytherapy
seeds. Additional pre- TULSA treatment imaging
may be needed to determine if TULSA is feasible,
as implants can lead to imaging interference and
impact ablation temperatures. The patient should
be thoroughly counseled on the risks versus benets of pursuing TULSA over alternative salvage
treatments (i.e., salvage prostatectomy, salvage
cryotherapy, radiation, or radiation with androgen
deprivation therapy). Patients should be informed
that there is currently a lack of data comparing
TULSA to other salvage treatments.
Fig. 30.10 One-year post-TULSA MRI with evidence of
anterior hemi-ablation and no new concerning lesions
A 63-year-old male with a history of grade
group 3 prostate cancer who underwent external
beam radiation therapy with ducial marker
One year after treatment, prostate MRI and
biopsy were unremarkable. He reported good urinary ow with slightly worse urgency than baseline, but the patient was overall not bothered by
this symptom. He reported good erections on
Sildenal 100 mg. One-year PSA was 2.2.
Figure 30.10 shows the 1-year prostate MRI
T2-weighted image with evidence of anterior
hemi-ablation with no evidence of residual or
recurrent tumor.
placement (initial PSA of 6.7 ng/mL, PSA nadir
of 0.6 ng/mL post-radiation) presents with a
progressive rise in his PSA.His PSA relapsed 3
years after his radiation therapy to 2.2 ng/
mL.PSA continued to increase over the next 2
years, prompting repeat prostate biopsies, which
were negative. PSA progressed to 17 ng/mL,
thus prompting an MR prostate, which showed a
PI-RADS 5 lesion in the right base anterior
peripheral zone extending into the anterior transition zone. PSMA PET/CT showed a recurrent
prostate lesion with no evidence of metastatic
TULSA intheSalvage Setting
disease (Fig.30.11a). Biopsy showed recurrent
grade group 3 disease, at which time PSA was
Patients who experience a prostate cancer recurrence after treatment may be offered restaging
with imaging to assess the extent of the disease
and biopsy if indicated [24]. Clinicians may obtain
a prostate MRI to assess for concerning lesions
within the gland and PSMA PET/CT to assess for
extra-prostatic disease. Targeted biopsy should be
pursued if there are concerning lesions on MRI.If
a workup reveals localized disease contained to
the prostate with a targetable lesion, clinicians
may consider offering TULSA in the salvage setting. A recent study showed salvage TULSA to be
effective at ablating prostate cancer recurrence in
29 ng/mL.The patient subsequently underwent
a near whole-gland (anterior two-thirds) treat-
ment plan with sparing of bilateral neurovascu-
lar bundles. Temperature mapping showed a
ducial effect on thermometry data, and a post-
treatment MRI showed the corresponding abla-
tion zone (Fig. 30.11b). At 6 months, he was
satised with his erectile function on Tadalal
10mg. His primary urinary complaint was post-
void dribbling, which did not appear to be
related to stress maneuvers. PSA at 3 months
was 2.9 compared to pre- procedure PSA of 29
ng/mL.
367

368
a
b
J. L. Chin et al.
Fig. 30.11 (a) Workup demonstrating recurrent lesion on
PSMA PET/CT and multiparametric prostate MRI. (b)
Near whole gland treatment plan with sparing of bilateral
NVB. Maximum temperature and thermal dose map of
Complications ofTULSA
andManagement ofComplications
treatment. Note the effects of ducial markers on ther-
mometry data. Posttreatment contrast-enhanced MRI with
corresponding ablation zone from near whole gland
ablation
advanced cases with palliative treatment intent.
There have been no rectal injuries or stula and no
fatalities, nor had there been any event of Common
Reported adverse effects of the TULSA procedure
were summarized in a meta-analysis by Dora etal.
in 198 men [14]. Subjects were either treatmentnaïve, salvage post-radiation, or locally advanced
for palliation. The initial cases were whole-gland
or near-whole gland ablation, while lesion-targeted “focal ablation” has been utilized more
recently in some centers, including some locally
Terminology Criteria for Adverse Events
(CTCAE) Grade >IV or Clavien- Dindo >IV.Grade
III adverse events occurred in 6%, mostly infective
problems managed with short hospitalization and
intravenous antibiotics (cystitis and epididymitis),
most likely attributable to the non-sterile environ-
ment where the procedure is conducted. Mandatory
prophylactic preoperative antibiotics and more

30 Role ofTransurethral Ultrasound Ablation (TULSA) inProstate Cancer Focal Therapy
369
attention to sterile techniques and draping should
lessen this concern. Post-procedure urinary retention necessitating endoscopic intervention comprised the remaining Grade III events.
Among men with primary prostate cancer
treated with curative intent, Grade II adverse events
were reported from 0% to 33% in the various
series. In order of frequency, the events comprised
urinary tract infections, urinary retention, urinary
incontinence (necessitating pad use), and epididymitis. In a cohort of 26 men with locally advanced
and/or radio-recurrent cancer undergoing palliative
TULSA, there was one Grade III event (retention
treated with suprapubic catheter and ureteral JJ
stents). Grade II events comprised urinary tract
infections (n = 10) and retention (n = 3) [14].
In a series of 180 patients (150 primary and 30
salvage), Muschter etal. reported on their “realworld” experience with lesion-targeted ablation
more recently that 40 patients experienced Grade
1 and 2 adverse events, resolving within a few
weeks with antibiotic therapy [11]. Grade 3
adverse events (urinary retention requiring surgical intervention) occurred in 2 patients. There
were no grade 4 or higher events and no bowelrelated complications. A total of 98% of men preserved pad-free continence. All 94 men who were
previously potent maintained their erectile
function.
There have been two known anecdotal cases
of severe incontinence post-whole gland
TULSA. Detailed analysis of treatment records
reviewed subtle shifts in ablation target due to
excessive prostate gland swelling, peristaltic
recto-sigmoid activity, or minor patient movement. This led to malalignment of the prescribed
treatment plan and underlying anatomy, resulting
ultimately in excessive energy delivered to the
external urinary sphincter region, which exceeded
the intended prescribed dose. Software modication (including the addition of a “history slider”
which helps identify minor target swelling or displacement, allowing target boundary adjustments
“on the y”) and heightened awareness by the
treating physician should minimize the risk of
such adverse events in the future. Moreover, focal
ablation with external sphincteric region sparing,
as opposed to whole gland ablation, should render severe incontinence even less likely.
A minority of patients, although with excellent oncologic results and reporting leak-free or
pad-free continence, have experienced prolonged
(months) periods of irritative or obstructive lower
urinary tract symptoms. An illustrative case is
detailed below:
A 67-year-old man presented with a serum
PSA of 6.3 ng/ml with a prostate gland volume of
33 cc (see pre-procedure MRI: Fig. 30.12).
Transrectal ultrasound-guided biopsy reviewed 4
of 12 cores positive for Grade Group 3 disease in
the left apex and left mid-gland. Whole-gland
TULSA was uneventful, with sparing of bilateral
neurovascular bundles and external sphincter
region. The patient developed acute prostatitis
Fig. 30.12 Pre-procedural T2-weighted prostate image. (a) Sagittal, (b) transverse image
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