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preoperative PSA (p¼0.07), or preoperative Gleason scores (p¼0.30).
The groups did not differ in patient-reported urinary function (Panel A,
p¼0.77) or bowel habits (p¼0.15). The moderate cold minimum tumor
temperature cohort reported more rapid improvement in sexual function
scores relative to the very cold cohort when compared to AS (Panel B,
***p<0.001, indicates comparison to AS at yearly intervals). The groups
did not differ in biochemical recurrence (Panel C, p¼0.57) or progres-
sion to salvage treatment (Panel D, p¼0.99).
CONCLUSIONS: Patients who underwent cryotherapy with a
moderate-cold minimum tumor temperature reported a more rapid re-
turn of sexual function, but had no difference in biochemical recurrence
or progression to salvage treatment relative to the very cold cohort.
Source of Funding: GTW was supported by NIH NRSA F30
MP30-10
HIFU DOSE ESCALATION LEADS TO FEWER RECURRENCES IN
FOLLOWING FOCAL HIFU IN PROSTATE CANCER
Philipp M. Huber*, Bern, Switzerland; Naveed Afzal, Dorset, United
Kingdom; Manit Arya, London, United Kingdom; Silvan Boxler, Bern,
Switzerland; Susan Charman, London, United Kingdom;
Andrew Cornaby, Dorset, United Kingdom; Tim Dudderidge,
Southampton, United Kingdom; Mark Emberton, Stephanie Guillaumier,
London, United Kingdom; Richard J. Hindley, Basingstoke, United
Kingdom; Lucas Leemann, Zurich, Switzerland; Henry Lewi,
Chelmsford, United Kingdom; Neil McCartan, Caroline M. Moore,
London, United Kingdom; Raj Nigam, Surrey, United Kingdom;
Chris Ogden, London, United Kingdom; Raj Persad, Bristol, United
Kingdom; Karishma Shah, London, United Kingdom;
George N. Thalmann, Bern, Switzerland; Jaspal Virdi, Harlow, United
Kingdom; Mathias Winkler, Hashim U. Ahmed, London, United Kingdom
INTRODUCTION AND OBJECTIVES: To determine if deliv-
ering greater amounts of focused Ultrasound heat energy when treating
non-metastatic prostate cancer using focal HIFU leads to lower recur-
rence rates.
METHODS: Based on the prospectively maintained HIFU
(Sonablate 500) registry cases were identified who underwent a focal
HIFU (03/2007 to 12/2016) with standard HIFU delivery or dose-escalated
HIFU. In-field treamtent failure was defined by any secondary treatment
(ADT/chemotherapy, cryotherapy, EBRT, RRP, or re-HIFU), metastasis
from prostate cancer without further treatment, tumour recurrence with
Gleason score 7 on prostate biopsy, or death from prostate cancer,
respectively. 131 cases were treated with two, and 59 cases with three
ablative zones respectively and could be used for a matched-pair
analysis. Two major criteria were used for mandatory exact matching
(baseline Gleason score and mpMRI-defined tumour volume). Other
criteria (biopsy maximum cancer core length (MCCL), duration of clin-
ical follow-up, and time to proof of recurrence) were also used and
nearest matching accepted. 37 matched pairs were identified. Statistics
by R-language.
RESULTS: In the standard HIFU and dose-escalated groups,
respectively, PSA (IQR) was 7.18ng/ml (4.6-10.3) and 6.7ng/ml (5.37-
8.5), mean prostate volume (range) was 46ml (17-103) and 52ml (19-
121), mean tumour volume (range) in both groups were identical at
0.6ml (0.05-2.5). For the two groups, respectively, median biopsy re-
sults (IQR) for number of positive cores, MCCL (in cm), and maximal
percentage of core were 6 (3-8) vs. 4 (3-5), 6 (4-9) vs. 5 (4-8), and 65
(40-80) vs. 50 (30-67). Gleason score (% of cases) was 3+3¼6 in 2/37
(5%), 3+4 in 31/37 (84%), and 4+3 in 4/37 (11%). Median time elapsed
until in-field failure was proven (IQR) was 13 month (11.5-24) compared
to 11.5 month (9.5-13). Overall, in-field recurrence (%) was found in 11/
37 (29.7%) in standard HIFU and 6/37 (16.2%) in dose-escalated HIFU
(p¼0.002).
CONCLUSIONS: Significantly higher rate of in-field treatment
failure in focal HIFU using the standard HIFU protocol on the Sonablate
500 compared to a dose-escalation by delivering more energy.
Source of Funding: NONE
MP30-11
PREDICTORS OF POOR FUNCTIONAL OUTCOMES AFTER FOCAL
HIGH INTENSITY FOCUSSED ULTRASOUND (HIFU)
Taimur T Shah*, London, United Kingdom; Max Peters, Utrecht,
Netherlands; Stephanie Guillaumier, London, United Kingdom;
Manit Arya, Harlow, United Kingdom; Naveed Afzal, Dorset, United
Kingdom; Feargus Hosking-Jervis, London, United Kingdom;
Tim Dudderidge, Southampton, United Kingdom; Richard Hindley,
Basingstoke, United Kingdom; Henry Lewi, Chelmsford, United
Kingdom; Neil McCartan, Caroline M Moore, London, United Kingdom;
Raj Nigam, Surrey, United Kingdom; Chris Ogden, London, United
Kingdom; Raj Persad, Bristol, United Kingdom; Karishma Shah,
London, United Kingdom; Jaspal Virdi, Harlow, United Kingdom;
Mathias Winkler, Mark Emberton, Hashim U. Ahmed, Suks Minhas,
London, United Kingdom
INTRODUCTION AND OBJECTIVES: The proportion of men
with return to baseline genitourinary function after prostate cancer
treatment is a poorly reported metric. We assessed return to baseline
function and pre-operative factors that might be associated with post-
operative incontinence, erectile dysfunction or change in International
Prostate Symptoms Score (IPSS) after focal HIFU.
METHODS: Within our prospective academic national HIFU
registry 625 patients underwent focal-HIFU (January 2006-December
2015) for non-metastatic prostate cancer. 360/625 completed both a
pre-operative and post-operative EPIC questionnaire, 254/625 an IIEF-
5 questionnaire and 271/625 an IPSS questionnaire. A multivariable
logistic regression and mixed model analysis was performed for EPIC
and IIEF-5 whereas a linear regression was performed for change in
IPSS score. EPIC outcomes were defined as either a) any leakage or b)
any pad usage. Erectile function outcome was based on a return to
baseline function of question 2 (when you had erections with sexual
stimulation how often were your erections hard enough for penetration,
scored from 0-5). IPSS outcome was defined as a change in IPSS score
from baseline.
RESULTS: Erectile Function: 189/254 (74%) regained their pre-
operative erectile function status. On logistic regression, factors pre-
dicting return to baseline IIEF were age [p<0.05, OR 1.06, 95%CI 1.01 -
1.12] and lower baseline function [p<0.05, OR 1.67, 95%CI 1.36 - 2.06].
Mixed model analysis revealed that for every baseline IIEF point, 0.61
(i.e. 61%) remains at 3 years.Continence: Any pad usage rate was 10/
360 (3%). 66/360 (18%) complained of small volume urinary leakage.
Significant factors for urinary leakage were age [p<0.05, OR 1.06, 95%
CI 1.02 - 1.1] and poor baseline function [p<0.05, OR 4.82, 95%CI 2.68
- 8.69]. IPSS: Baseline median IPSS score was 8 [IQR 5 - 13]; this did
not show any change post-operatively. The only significant variable was
baseline IPSS score; patients with higher scores having the largest
decrease in their IPSS score (p<0.05)
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Vol. 199, No. 4S, Supplement, Saturday, May 19, 2018
CONCLUSIONS: These medium-term patient-reported out-
comes confirm a high degree of functional preservation after focal-
HIFU. Those patients with increasing age and poor baseline function
have inferior outcomes. Baseline EF had an inverse relation with
outcome. In other words, men with poorer baseline function tending to
remain at similarly (poor) levels post-operatively. However, those with
higher baseline function are the most likely to be able to have erections
sufficient for intercourse but tend not to regain overall IIEF-5 score to
baseline levels.
Source of Funding: None
MP30-12
FOCAL CRYOABLATION IS ASSOCIATED WITH SUPERIOR
QUALITY OF LIFE AND NO DIFFERENCE IN DISEASE CONTROL
RELATIVE TO TOTAL CRYOABLATION IN PROSTATE CANCER
PATIENTS
Glenn T. Werneburg*, Stony Brook, NY; Michael Kongnyuy,
Daniel M. Halpern, Jose M. Salcedo, Mineola, NY; Connie Chen, Stony
Brook, NY; Amanda L. LeSueur, Kaitlin E. Kosinski, Jeffrey T. Schiff,
Anthony T. Corcoran, Aaron E. Katz, Mineola, NY
INTRODUCTION AND OBJECTIVES: Cryotherapy is an
effective definitive treatment for prostate cancer. Cryotherapy may be
performed as total ablation of the prostate, or focal ablation with the
intention of sparing one or both neurovascular bundles. We sought to
determine whether focal ablation of the prostate is associated with
improved quality of life (QoL), and/or an increased risk of disease
recurrence relative to total cryoablation.
METHODS: An IRB-approved database was reviewed for pa-
tients who underwent primary total or focal cryotherapy for prostate
cancer from 2004 to 2017. EPIC quality of life questionnaire responses,
biochemical recurrence, and progression to salvage treatment over the
4 years post-treatment were analyzed and compared using ANOVA, t-
tests, Kaplan Meier analyses, and log-rank tests. Candidates for focal
ablation were chosen based on the combination of criteria including
PSA less than 10, unilateral disease, lack of extracapsular extension,
interest in maintaining sexual function, and age.
RESULTS: Of the 300 patients analyzed for disease and QoL
outcomes, 104 patients had total cryoablation, and 196 had focal cry-
oablation (hemiablation). Biochemical recurrence data were available
for 232 patients. A total of 335 EPIC QoL questionnaires were included
in analysis for 89 patients in the focal group and 38 patients in the total
group in the 4 years following treatment. For the focal group, median
age was 69 (SD: 8.7), preoperative PSA 6.1 (1.2), available preopera-
tive Gleason scores were <7: 83, 7: 87, 8+: 19. For the total group,
median age was 72 (6.9), preoperative PSA 6.1 (5.7), available pre-
operative Gleason scores were <7: 21, 7: 48, 8+: 32. The cohorts did
not differ in 4-year post-procedural urinary function (Panel A, p>0.05) or
bowel habits (p>0.05). The focal cryotherapy cohort reported superior
sexual function scores relative to the total cryotherapy cohort (Panel B,
***p<0.001). The groups did not differ in biochemical recurrence (Panel
C, p¼0.55) or progression to salvage treatment (Panel D, p¼0.52) in the
4 years post-procedure.
CONCLUSIONS: Focal cryotherapy results in similar levels of
disease control and urinary function, but superior sexual function rela-
tive to total cryotherapy in the 4 years following treatment.
Source of Funding: GTW was supported by NIH NRSA F30
MP30-13
EFFECT OF THE TYPE OF CRYO PROBE ON ONCOLOGICAL &
FUNCTIONAL OUTCOMES FOR PRIMARY WHOLE GLAND
PROSTATE CRYOABLATION
Ahmed Elshafei*, cleveland, OH; Thomas Polascik, Durham, NC;
Asmaa Hatem, cleveland, OH; Ashley Ross, Baltimore, MD;
Robert Given, Eastern Virginia, VA; Jim C. Hu, New York, NY;
Michael Cher, Detroit, MI; J. Stephen Jones, cleveland, OH
INTRODUCTION AND OBJECTIVES: To compare the effect of
the Variable ice cryo probe (V-probe) and the conventional sharp probe
on oncological & functional outcomes in men treated with primary whole
gland prostate cryoablation.
METHODS: Among 4235 men treated with primary whole gland
prostate cryoablation, we identified 1569 men with complete data and
known type of cryo probe used. V-probes were used in 335 & sharp
probes in 1234 cases. Primary outcomes included biochemical pro-
gression-free survival, post-treatment urinary incontinence, urinary
retention, erectile dysfunction (ED), and recto-urethral fistulae.
RESULTS: Median age was 71 years (IQR 66-76), median
Gleason sum was 7 (IQR 6-7) and median PSA was 6.5 ng/mL (IQR
4.8-9.5). The use of the V- cryo probe was associated with men who
were less likely to have clinical stage T2b disease (15.8% vs 37.8%,
p<0.001), of non-African American race (82.2% vs. 87.9%, p¼0.02),
have lower median PSA (5.8 vs. 6.7 ng/ml, p<0.001), have higher
median total prostate volume (TPV) (35.5cc vs. 34cc, p¼0.01) and were
less likely to undergo neoadjuvant androgen deprivation therapy (21.5%
vs. 29.5%, p¼0.004) compared to sharp probe cases. In unadjusted
analyses, using the V-cryo probe was associated with a lower
biochemical failure rate (11.5% vs. 18.3%, p¼0.003), higher risk of post-
operative urinary retention 71/335 (21.2%) vs. 126/1234 (10.2%),
p<0.001 and a lower risk to develop of new onset ED 61/151 (40.4%)
vs. 295/ 510 (57.8%), p<0.001 at 12 months, compared to using the
sharp probe. There was no statistically significant differences in recto-
urethral fistula (p¼0.9) or urinary incontinence rates (p¼0.9).On multi-
variable regression, using V-cryo probes was an independent predictor
of decreased risk of biochemical failure (OR 0.58, 95% CI 0.40-0.85,
p¼0.005), increased risk of urinary retention (OR 2.5, 95% CI 1.7-3.7,
p<0.001) and decreased risk of 12 month new onset ED (OR 0.57, 95%
CI 0.39-0.86, p<0.001, Table1)
CONCLUSIONS: The use of the variable ice cryo probe (V-
probe) was associated with an improved success rate of biochemical
outcome compared to the sharp probe. The incidence of post-operative
erectile dysfunction was lower with the use of the V-probe, however, at
the expense of an increased risk of post-operative urinary retention
compared to the conventional sharp probe.
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