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Yoh Matsuoka*, Noboru Numao, Kazutaka Saito, Hiroshi Tanaka,
Masaharu Inoue, Masaya Ito, Soichiro Yoshida, Minato Yokoyama,
Junichiro Ishioka, Yasuhisa Fujii, Kazunori Kihara, Tokyo, Japan
is performed with sufcient intensity to eradicate cancer, accurate
evaluation for the extent of signicant cancer (SC) is essential to avoid
undertreatment. By D0Amico risk category of prostate cancer (PC), we
assessed the possibility of underdiagnosis by MRI and biopsy for: 1)
extra-prostatic extension (EPE) at the ablation eld; and 2) SC left in
untreated area. We then veried the applicability of quadrant-based
regional FT to intermediate- and high-risk PC, compared with low-
risk PC.
METHODS: We enrolled 203 PC patients in clinical stage T2
on digital rectal examination who underwent multiparametric MRI,
systematic 14-core biopsy, and radical prostatectomy. MRI interpre-
tation followed the Prostate Imaging Reporting and Data System
version 2. Cancer distribution was analyzed using a quadrant basis.
Anterior and posterior prostatic quadrants were assessed through 4
anterior/lateral cores and 4 posterior/lateral cores, respectively.
Additional MRI-targeted sampling was included in the assessment of
Gleason score (GS). SC was dened as a lesion with volume 0.5 mL
and/or GS 4+3 and/or EPE. We consider that the absence of EPE is
a precondition for FT and that the absence of SC is prerequisite for the
untreated area. Each prostate was examined for EPE using MRI, and
each quadrant was then assessed for SC using MRI and 4 biopsy
RESULTS: In total, 35/109/59 men were classied as low-/
intermediate-/high-risk cases, respectively. In each risk groups,
radiological EPE (rEPE) features on MRI were absent in 31/49/21 men
(89/45/36% of each group). Among men without rEPE features in each
group, EPE was pathologically absent in 30/47/19 men (97/96/90%)
(p¼1.00 and 0.56 in intermediate- and high-risk groups, respectively,
vs. the low-risk group). In men without rEPE features, SC was absent
in 44/55/23 anterior quadrants (71/56/55%) and 46/55/22 posterior
quadrants (74/56/52%). Negative predictive values of the combination
of MRI and biopsy for SC were 95/96/100% in anterior quadrants
(p¼1.00 and 1.00 in intermediate- and high-risk groups, respectively,
vs. the low-risk group) and 94/98/89% in posterior quadrants (p¼0.58
and 0.61).
CONCLUSIONS: In intermediate- and high-risk PC selected
through MRI and biopsy, EPE is absent in 96% and 90% of men,
respectively, and SC left in the untreated area is absent in 96-98% and
89-100% of quadrants, respectively, which suggests that FT is an option
for intermediate-risk PC as well as low-risk PC. Although carefully-
selected high-risk PC might also be a candidate for FT, further study
using a larger cohort is needed.
Source of Funding: none
Stephanie Guillaumier*, Sami Hamid, Susan Charman,
Susan Charman, Jan van der Meulen, Neil McCartan, Karishma Shah,
London, United Kingdom; Richard Hindley, Basingstoke, United
Kingdom; Raj Nigam, Surrey, United Kingdom; Tim Dudderidge,
Southampton, United Kingdom; N Afzal, A Cornaby, Dorset, United
Kingdom; H Lewi, Chelmsford, United Kingdom; Raj Persad, Bristol,
United Kingdom; J Virdi, Harlow, United Kingdom; Caroline Moore,
London, United Kingdom; Manit Arya, Harlow, United Kingdom;
Mark Emberton, Hashim Uddin Ahmed, London, United Kingdom
High Intensity Focused Ultrasound (HIFU) in the treatment of localised
prostate cancer has been shown to provide encouraging short-term
disease control with a low genito-urinary side effect prol. Our UK
prospective academic HIFU registry incorporates over 2000 cases from
8 centres that were treated with HIFU, spanning from 2004 to 2015. We
report on the medium term oncological and functional outcomes of
those treated wth focal HIFU.
METHODS: 625 patients diagnosd with T1aN0MO to T3bN0M0
prostate cancer were treated with focal HIFU. The diagnostic pathway
involved a multi-parametric MRI followed by transperineal mapping bi-
opsies and/or MR-targeted biopsies. Metastatic disease was excluded
in the intermediate- and high-risk patients by radioisotope bone scan
and/or cross-sectional CT. Focal HIFU was carried out by quadrant or
hemi-ablation of the prostate gland depending on disease location.
Some patients underwent index lesion ablation alone, provided that the
untreated area had no more than Gleason 6 disease with a maximum
core length of 5mm. Patients were followed-up using PSA levels, as
well as repeat prostate biopsies and MRI, if necessary.
RESULTS: Of 625 patients, 80 (13%), 491 (81%) and 39 (6%)
had low, intermediate and high-risk disease, respectively. With a
median follow-up of 56 (IQR 33-70) months. Median pre-operative
PSA was 7.1 (IQR 5.1-9.9). Median PSA nadir was 1.7ng/L by 4.5
429 had baseline urinary continence status recorded. At 1-2 years
and 2-3 years after focal-HIFU, pad-free status was available in 314
and 247, at baseline and follow-up; 305 (97%) and 241 (98%) were
pad-free (0 pads), respectively. At 1-2 years and 2-3 years after focal-
HIFU, continence status was available in 251 and 195, at baseline and
follow-up; 209 (83%) and 156 (80%) were pad-free, leak-free conti-
nent, respectively.
425 had baseline erectile function recorded. At 1-2 years and 2-3
years, erectile function status was available in 165 and 101, at
baseline and follow-up; 138 (84%) and 87 (86%) maintained erectile
function at 1-2 and 2-3 years following focal-HIFU, respectively. Two
(0.8%) developed a recto-urethral stula of which one healed with
urinary diversion alone and the second required operative
Of 222 patients that underwent post-operative biopsies, 29 were
found to have in-eld recurrence, 16 out-of-eld de novo disease or
progression and 11 had both. 122 (20%) had a further focal-HIFU
treatment, whilst 44 (7%) transitioned to radical whole-gland therapy
(1% prostatectomy; 6% radiotherapy) whilst 7 (1%) required systemic
hormones alone.
Eight died during follow-up, however, none from prostate cancer.
The metastasis-free survival and overall survival (95%CI) at 5 years
were 97% (95-98) and 99% (97-99), respectively.
CONCLUSIONS: Focal HIFU has acceptable rates of cancer
control with a low genito-urinary side-effect prole in the medium- term
and across a number of centres. It is a low cost, ambulatory and
repeatable procedrre that is minimallyinvasive.
Source of Funding: Sonacare Inc.
Nicola Fossati, Giorgio Gandaglia, Nazareno Suardi*,
Umberto Capitanio, Paolo DellOglio, Emanuele Zaffuto, Vito Cucchiara,
Alessandro Larcher, Armando Stabile, Elena Farina, Andrea Salonia,
Francesco Montorsi, Alberto Briganti, Milan, Italy
INTRODUCTION AND OBJECTIVES: While it has been agreed
that the candidate for focal therapy (FT) is a men with low- to inter-
mediate-risk disease, a recent consensus meeting did not agree on a
maximum tumour volume (TV) beyond which FT is deemed not suitable.
However, such lack of consensus may potentially harm a signicant
proportion of men who could still receive FT despite high TV. We hy-
pothesized that TV may differently impacts oncologic outcomes ac-
cording to tumour characteristics
Vol. 195, No. 4S, Supplement, Friday, May 6, 2016 THE JOURNAL OF UROLOGY
... We have recently reported on cancer control [8]. The aim of this study was to determine the impact of focal cryotherapy on urinary and sexual function, and assess the return to baseline urinary and sexual function using the International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF)-15 questionnaires. ...
Background: The oncological outcomes in men with clinically significant prostate cancer following focal cryotherapy are promising, although functional outcomes are under-reported. Objective: To determine the impact of focal cryotherapy on urinary and sexual function, specifically assessing return to baseline function. Design, setting, and participants: Between October 2013 and November 2016, 58 of 122 men who underwent focal cryotherapy for predominantly anterior clinically significant localised prostate cancer within a prospective registry returned patient-reported outcome measure questionnaires, which included International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF-15) questionnaires. Intervention: Standard cryotherapy procedure using either the SeedNet or the Visual-ICE cryotherapy system. Outcome measurements and statistical analysis: Primary outcome was return to baseline function of IPSS score and IIEF erectile function (EF) subdomain. Cumulative incidence and Cox-regression analyses were performed. Results and limitations: Probability of returning to baseline IPSS function was 78% at 12 mo and 87% at both 18 and 24 mo, with recovery seen up to 18 mo. For IIEF (EF domain), the probability of returning to baseline function was 85% at 12 mo and 89% at both 18 and 24 mo, with recovery seen up to 18 mo. Only the preoperative IIEF-EF score was associated with a poor outcome (hazard ratio 0.96, 95% confidence interval 0.93-0.999, p = 0.04). The main limitation was that only half of the patients returned their questionnaires. Conclusions: In men undergoing primary focal cryotherapy, there is a high degree of preservation of urinary and erectile function with return to baseline function occurring from 3 mo and continuing up to 18 mo after focal cryotherapy. Patient summary: In men who underwent focal cryotherapy for prostate cancer, approximately nine in 10 returned to their baseline urinary and sexual function. Keeping in mind that level 1 evidence and long-term data are still needed, in men who wish to preserve urinary and sexual function, focal cryotherapy may be considered an alternative treatment option to radical therapy.
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