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306
Fig. 26.6 We show the MR fusion TT cryoablation patients trends in median PSA, PSAD, % of prostate gland ablated,
treatment times, and patient age, which have been decreasing over time
F. J. Bianco and G. Maiolino
Fig. 26.7 The gure shows the observed rates of adverse events for either MR fusion TT using FLA (left) and cryoablation (right)
Outcomes
lation using MR/US fusion imaging in a clinical
setting [76]. In the same year, we published the
Although the intermediate evaluation of functional and oncological results, which necessitates
a prolonged follow-up, has been nished and is
currently being submitted to a peer-reviewed
journal, various interim analyses have been published in abstract forms over the years. In 2018,
we disclosed a video that demonstrated the possibility and reproducibility of performing cryoab-
outcomes of 1015 procedures (626 transperineal
biopsies and 389 transperineal cryoablations)
conducted in an ofce environment. The purpose
was to exhibit that transperineal procedures in an
ofce setting were practical and safe, with the
focus being on pain levels and 30-day complica-
tions classied using the Clavien-Dindo system.
Traditionally, the transperineal approach for pro-
26 Oce-Based Outpatient Focal Therapy Under Local Anesthesia
Fig. 26.8 We zoomed into MR fusion TT using cryoablation; overall, 8.2% of patients experienced an adverse event,
the most common by far was urinary retention representing 56% of all AEs
307
Fig. 26.9 Stratication of MR fusion TT using cryoablation according to Clavien-Dindo system
cedures related to the prostate was deemed insufcient for ofce settings owing to the sensitivity
and challenging access of the perineal area, frequently requiring lithotomy or exaggerated
lithotomy positioning. As a result, many authors
advocated for general or spinal anesthesia for
such procedures. However, our research showed
that our technique [43], which provided an “optimal” local perineal block, utilized in both brief
biopsies and longer cryoablations (with mean
procedural times of 22 and 60 min, respectively),
yielded similar pain scores (measured using the
Wong-Baker pain faces scale). To conclude, our
ndings validated the idea that transperineal pro-
cedures performed under local anesthesia in an
ofce setting were well-tolerated and had a very
favorable AE prole [42]. Additionally, we spe-
cically documented outcomes from the initial
308
Fig. 26.10 Stratication of patients who experienced an AE after MR fusion TT using cryoablation
F. J. Bianco and G. Maiolino
348 prostate cancer patients enrolled in the “MRI/
Ultrasound Fusion-Guided Prostate Cryotherapy
(FIPC)” trial (NCT02381990). Cryoablation was
exclusively performed in an ofce setting under
local anesthesia. Across the 348 patients, a total
of 398 procedures were conducted, all of which
were successfully completed, with a median
reported pain level of 2 out of 10. The patients
had a median age of 71 years (range 51–87), with
the majority classied as having low- to
intermediate- risk prostate cancer. At a mean follow- up of 2 years, only 14% required retreatment, while 4% underwent conversion to
surgery or radiation therapy. Additionally, we
observed a high rate of erectile function, with
84% reporting erections with or without PDE5
inhibitors. As for the urinary function side,
patients reported improvement in IPSS scores,
and we noted improvement in Qmax and Qave
ows in 70% of the patients. There were two
additional notable results for the sexual and urinary function domains. On the sexual function
side, 72% of patients continued to have ejaculations at 3–6 months post-TT, and urinary incontinence for the urinary function side was absent
[51].
In 2019, an interim analysis was conducted to
investigate the effectiveness of the PI-RADS system in MRI imaging performed one year after
MR/US Fusion cryoablation as part of the
NCT02381990 trial. The effectiveness of this
system was previously validated only for
treatment- naïve patients, and consequently, there
was limited information regarding its performance in radiological follow-up of patients
treated with TT.Our analysis revealed that out of
the 201 patients who underwent prostate biopsy
after one year, encompassing both treated and
untreated areas, the PI-RADS system that we
used for untreated areas or DCE on the treated
area correlated signicantly with the presence of
cancer. Furthermore, 94% of patients with
PI-RADS scores of 1–2 did not have cancer.
These outcomes suggest that a change from mandatory biopsy to optional is appropriate for those
patients having no DCE and a PIRADS 1–2in the
untreated area on the MRI performed after one
year of TT [50].
Our analysis was complemented as our cohort
continued to mature, and in 2023, we evaluated
the performance of the PIRADS 2.1 system on
MRI imaging taken one year after the MRI/
Ultrasound Fusion-Guided Prostate Cryotherapy
or Focal Laser ablation when utilized for
untreated prostate tissue reporting. Among the
454 patients who underwent prostate biopsy after
1 year, PIRADS 2.1 system detected 5%, 44%,
and 77% of PI-RADS scores 1–2, 3, and 4–5
lesions, respectively, hence conrming our earlier ndings. It can be concluded that there is a
26 Oce-Based Outpatient Focal Therapy Under Local Anesthesia
309
denite role for the PIRADS system in assessing
untreated prostate tissue after TT or partial gland
ablation [52].
In 2021, we initiated an exploration of changes
in the natural history of prostate cancer treatment, prompted by TT in the NCT02381990 registration trial. The preliminary analysis, which
we presented as an abstract, involved 534 patients
with a median PSA of 6.1 ng/ml who underwent
MR Fusion TT in the ofce setting and were followed up for at least 1 year. This analysis showed
favorable short-term oncological outcomes, with
69% of patients showing freedom from prostate
cancer on biopsy results at one year. Additionally,
97 patients required re-treatment, and 29 patients
underwent conversion to surgery [17] or radiation therapy [12].
In 2024, at the national meeting of the AUA,
we presented an expanded version, which is currently under submission [77]. It included an
intermediate-term, mature competing risk analysis of 1,168 patients with a median age (interquartile range-IQR) of 70 years [67–78]. The
characteristics of this cohort were indicative of
men presently diagnosed with prostate cancer, as
74% had non-palpable (T1c) tumors. The median
(IQR) PSA and PSAD levels of the cohort were
6.2 ng/dl (4.7–8.8) and 13% (9–19%), respectively. Concerning the patients’ MRI PIRADS
scores, 60 had scores of 1–2, 401 had a score of
3, 403 had a score of 4, and the remaining 304
had a score of 5. Similarly, 497, 414, 172, and 85
of the patients in this cohort had preoperative
respective Gleason Grade Groups tumors of 1, 2,
3, 4–5. In Fig.26.11, you can see the curves displaying the competition between Disease
Progression (DP) and Death from Other Causes
(DOC) that are not related to prostate cancer. DP
is a combined outcome that pertains to patients
who undergo surgery, radiation, whole gland
ablation, initiation of androgen deprivation therapy, or develop metastasis. This composite outcome is being compared with deaths that occurred
as a result of non-prostate cancer-related causes.
The plot involves over 90 events and follows the
progress of 200 men who underwent MR Fusion
TT.Based on the estimates given, we see that the
DP and DOC had gures of 14% and 9%, respectively, during a follow-up period of 5 years [77].
It is also noteworthy that the disease was controlled within 75% of the cohort by the 8-year
mark. We presented an intriguing analysis comparing DP rates by Gleason Grade Groups (GG)
at the 2024 AUA national meeting, as indicated
above [78]. Surprisingly, the data showed no statistical or clinical difference between patients
who had biopsy GG1 versus GG2 (p = 0.9), as
depicted in Fig. 26.12. However, when both
Fig. 26.11 Competing risk analysis: (a) shows the competing risk plot evaluating conversion vs death from other
causes (DOC) of MR fusion TT using cryoablation; (b) shows preliminary risk predictors—PSAD and MR volume
310
Fig. 26.12 Conversion-free estimates of patients having MR Fusion TT using cryoablation by Gleason Grade Groups
(GGG)
F. J. Bianco and G. Maiolino
groups were combined and compared with GG3,
we found a statistically signicant difference
within 5 years (p = 0.04). Nonetheless, DP was
noticed in only 20% of those who had preoperative GG3 tumors, revealing a promising possibility for TT treatment in patients with these tumors
[78]. You can access more recent information by
taking a snap on your phone.
Conclusion
Based on our assessment, it appears that ofcebased targeted therapy is currently a viable option
for patients. These procedures, which use focal
laser ablation or cryoablation, are safe, welltolerated, and typically take between 30 and
60 min to complete. Additionally, there is a low
probability of adverse events occurring within 30
days, and in the instance of an AE, it can be managed within the ofce setting approximately 75%
of the time. From a urinary function standpoint,
patients often report improvement, but urinary
incontinence is not typically a concern. Sexual
function-related risks are also low, with less than
20% of patients experiencing erectile dysfunction.
The use of MR fusion technology is a key factor in
achieving precision during these procedures. By
providing physicians with a clear view of critical
anatomical landmarks, including the bladder neck,
urethral sphincter, foley catheter, and neurovascular bundles, targeted ablation can be carried out
effectively and safely. Ultrasound images can also
be monitored in real-time, with clear visibility of
the ablated area and critical landmarks. Early
results show promising outcomes for patients with
localized prostate cancer, providing an alternative
to radical treatments or observation/surveillance
protocols. Targeted therapy offers an opportunity
for patients to halt the progression of known
tumors while avoiding the negative side effects
associated with other treatment approaches.
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Part VII
Transperineal Technologies
for Focal Therapy
Focal Brachytherapy
(Interventional Radiotherapy)
andIMRT
27
Clinical Background
The improvements in the detection and characterization of prostate cancer, together with technical
developments, led to the idea of minimizing
harms resulting from overdiagnosis and overtreatment [1]. These led in 2010 to the birth of a
Transatlantic Consensus Group [2]. Focal radiotherapy, either external beam radiotherapy (ERT)
or brachytherapy (BT, interventional radiotherapy—IRT), is one of the appropriate therapeutic
strategies for partial organ treatment in prostate
cancer [3]. Additionally, because of the existence
of multiple focal therapy technologies, an adequate and personalized treatment decision needs
L. Tagliaferri · B. Fionda (*)
U.O.C.Radioterapia Oncologica, Dipartimento di
Diagnostica per Immagini, Radioterapia Oncologica
Ed Ematologia, Fondazione Policlinico Universitario
Agostino Gemelli IRCCS, Rome, Italy
e-mail: luca.tagliaferri@policlinicogemelli.it;
bruno.onda@policlinicogemelli.it
J. Grummet
Department of Surgery, Central Clinical School,
Monash University, Melbourne, VIC, Australia
A. See
Icon Cancer Centre, Richmond, VIC, Australia
e-mail: Andrew.see@icon.team
G. Kovács
Gemelli-INTERACTS, Università Cattolica del Sacro
Cuore, Rome, Italy
interdisciplinary team discussion with the inclusion of an adequate IRT expert [4].
In particular, the argument raised in favor of
focal therapy was that the proportion of unifocal
tumors in patients undergoing radical prostatectomy was between 13% and 38%; more specically, when considering low-risk patients, most
of them had higher primary Gleason grades contained within the dominant intraprostatic lesions
(DIL) [5]. With the growing clinical interest in
this kind of approach, several interdisciplinary
research groups proposed the idea of sparing
healthy prostate tissue around DIL with the aim
of reducing treatment-related toxicity [6].
Furthermore, the Transatlantic Consensus Group
published an International Consensus paper on
the appropriate design of future Focal Therapy
Studies in prostate cancer [7].
© 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_27