Comparing Oncological and Functional Outcomes

Report
Rashid TG, Dudderidge T,
Zahur S, Kini M, Ogden CW
Overview

Method

Results


Patient Characteristics & Treatment Factors

Oncological Results

Functional Results
Summary
Method

Patient group:
 30 patients undergoing RALP (DaVinci robot)
 30 patients undergoing HIFU (Sonablate ® 500)
 Consecutive cases, all performed by Chris
Ogden over the same time period

Functional questionnaires

PSA follow-up

At 0, 3, 6, 9, 12, 18 and 24 months
Patient Characteristics
RALP
HIFU
N
30
25 (Primary)
5 (Salvage)
Age (yrs)§
Median (range)
60 (42-74)
67 (51-78)
71 (61-79)
Presenting PSA
(ng/dL)*
Median (range)
7.0 (2.4-18.0)
6.6 (3.0-14.0)
6.0 (4.1-20.0)
≤6
14
11
0
=7
14
10
2
>7
2
1
0
Unknown
0
9
3∞
T1c
5
3
0
T2a
6
4
1
T2b
2
2
0
T2c
14
4
2
T3a
0
0
0
T3b
0
0
0
Unknown
3
12
2
1
4
1
Gleason score*
T stage*
Pre-treatment
hormones
§Significant
difference between RALP and HIFU groups using Mann-Whitney, p=0.003
*No significant difference between RALP and HIFU groups using Mann-Whitney or Fisher’s exact test, p=0.003
∞Post-radiotherapy
Treatment factors
RALP
HIFU (Primary)
HIFU (Salvage)
Length of stay (days)
Median (range)
2 (1-4)
1
1
Catheter type
U = urethral
SP = suprapubic
30 U
3 SP
22 U
1 SP
4U
Catheter time (days)
Median (range)
14 (10-48)
10 (10-24)
10 (7-16)
Oncological Outcomes
Median follow-up
18 months (3-24)
Cancer Recurrence
RALP recurrences
HIFU recurrences
2/30 PSA recurrences
Recurrence
€
7/25 Primary HIFU
PSA recurrences
HIFU
RALP
G4+5 T3b
N
G4+3 T3a
30
PSA €
2
ASTRO∞
-
Phoenix*
-
Re-Biopsy
-
Primary
Salvage
7
3
8
3
3 post-HIFU biopsies
25
5
1 had repeat
HIFU, the remainder
are
undergoing
PSA monitoring
7
3
3/5 salvage HIFU PSA recurrences
1 moved to3 USA
1 repeat biopsy
1 PSA surveillance
1
PSA Recurrence defined as PSA >0.2ng/dL (RALP) or >0.5ng/dL (HIFU)
∞ ASTRO criteria: 3 consecutive rises in PSA, with time of recurrence defined as mid-way between nadir and recurrence
months
* Phoenix criteria: nadir + 2ng/mL, time of recurrence at call
Cancer Recurrence – time to relapse
Time to relapse (Surgery PSA>0.2, HIFU PSA>0.5)
1.0
Relapsed
Months
from
treatment
RALP
HIFU
(Primary)
HIFU
(Salvage)
3
0
2
2
6
1
1
1
9
0
1
0
12
0
1
0
18
1
1
0
24
0
1
0
Total
2
7
3
Treatment
% Relapse-free
0.8
HIFU Primary
Surgery
HIFU Salvage
0.6
0.4
0.2
0.0
0
5
10
15
Months from treatment
20
25
There was a significant difference in time of PSA recurrence between all groups, (Wilcoxon
(Gehan) statistic, p<0.001)
Treatment type remained significant after adjusting for age (p=0.001, HR 0.11 with 95% CI
0.029 to 0.416).
Functional Outcomes
Median follow-up
18 months (3-24)
Sexual Function
IIEF change from baseline
10
Change from baseline
0
3m
6m
9m
12m
18m
24m
-10
-20
HIFU Primary
-30
Surgery
-40
-50
-60
Months from treatment
From 6 months, HIFU patients demonstrate a significantly higher rate of
return to baseline function (p<0.05)
Potency


100%
90%
80%
Significant differences seen only at 9 and 24 months1 with HIFU
patients being more successful
HIFU hard
Ability RALP
to achieve erections sufficiently
enough for penetrative sexual intercourse (with
or without pharmaceutical assistance)
100%
90%
80%
70%
70%
67%
60%
6%
60%
14%
50%
50%
40%
40%
27%
83%
78%
Potent
71%
Not active (%)
6%
38%
30%
13%
22%
30%
21%
20%
20%
10%
10%
0%
0%
3
1
6
9
12
18
24
p<0.007, p<0.026 respectively, Fisher’s exact test
3
6
9
12
18
24
Urinary Symptoms
70
60
% of Patients
50
40
30
20
10
0
3
RALP 46.4
HIFU 21.7
6
28
35
9
12
36.4
45
55.6 57.1
Months
18
30
60
24
37.5
There is no significant difference in urinary symptoms for this cohort of patients, p<0.05
Urinary Continence

3 HIFU patients (1 primary, 2 salvage)
required artificial urinary sphincters

remainder
cf The
1 RALP
patientin
both groups have good
urinary control

Those who wear pads do so for security
only
Overall Functional Well-Being
HIFU Primary
5
4
Surgery
Change from baseline
3
2
1
0
3m
6m
9m
12m
18m
24m
-1
-2
-3
-4
-5
-6
Months from treatment
There is no significant difference in functional well-being between the two
cohorts, p<0.05
Complications
Complication
RALP
HIFU
(Primary)
HIFU
(Salvage)
Anastomotic leak
1*
-
-
Stricture
2
4
-
Infection
1
3
1
Debris passage
-
6
-
Fistula
-
AUR/blocked catheter
Intervention – Diagnostic
Intervention - Therapeutic
1
4
-
Flexible cystoscopy
2
6
1
GA cystoscopy
-
1
2
TURP
-
3€
-
BNI
-
-
1
Weck clip removal
1
-
-
Dilatation
2
4
2
Artificial sphincter
1
1
2
TIA
1
-
-
PE
1
-
-
Lung cancer
-
1
-
Death
-
1 (lymphoma)
-
Non-surgical
*Associated small pelvic collection, not requiring intervention but delaying discharge
€ 2 procedures on same patient
Complications (C)
Inpatient
Stay
Catheter
time
(days)
Recurr
ence
rate
Sexual
function
Urinary
Symptoms
Diagnostic
interventions (D)
Therapeutic
interventions (T)
RALP
HIFU
(Primary)
HIFU
(Salvage)
Median
2
(1-4)
Median
14
(10-48)
Day case
Median
10
(10-24)
7
(28.0%)
Day case
Median
10
(7-15)
3
(60.0%)
2
(6.7%)
Earlier
return to
baseline
in HIFU
No significant
difference in
symptoms
No. of
patients
requiring >1
therapeutic
intervention
10 (C)
7 (D)
2 (T)
0
22 (C)
10 (D)
12 (T)
3 (12%)
9 (C)
5 (D)
9 (T)
3 (60%)
Thank you
for your
attention

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