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 CharacteristicsRALP 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)

Gleason score*

≤6 14 11 0

=7 14 10 2

>7 2 1 0

Unknown 0 9 3∞

T stage*

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

Pre-treatment hormones

1 4 1

§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 typeU = urethral

SP = suprapubic 30 U

3 SP22 U

1 SP4 U

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

Recurrence RALPHIFU

Primary Salvage

N 30 25 5

PSA € 2 7 3

ASTRO∞ - 7 3

Phoenix* - 8 3

Re-Biopsy - 3 1

RALP recurrences

2/30 PSA recurrences

G4+5 T3b

G4+3 T3a

€ 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

HIFU recurrences

7/25 Primary HIFU PSA recurrences

3 post-HIFU biopsies

1 had repeat HIFU, the remainder are undergoing PSA monitoring

3/5 salvage HIFU PSA recurrences

1 moved to USA

1 repeat biopsy

1 PSA surveillance

Cancer Recurrence – time to relapse

Months from treatment2520151050

% R

ela

ps

e-f

ree

1.0

0.8

0.6

0.4

0.2

0.0

Time to relapse (Surgery PSA>0.2, HIFU PSA>0.5)

HIFU SalvageSurgeryHIFU Primary

Treatment

Months from

treatment

Relapsed

RALPHIFU

(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

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

From 6 months, HIFU patients demonstrate a significantly higher rate of return to baseline function (p<0.05)

Potency

Ability to achieve erections sufficiently hard enough for penetrative sexual intercourse (with or without pharmaceutical assistance)

Significant differences seen only at 9 and 24 months1 with HIFU patients being more successful

1 p<0.007, p<0.026 respectively, Fisher’s exact test

Urinary Symptoms

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

cf 1 RALP patient The remainder in both groups have good urinary control

Those who wear pads do so for security only

Overall Functional Well-Being

There is no significant difference in functional well-being between the two cohorts, p<0.05

ComplicationsComplication RALP

HIFU (Primary)

HIFU (Salvage)

Anastomotic leak 1* - -

Stricture 2 4 -

Infection 1 3 1

Debris passage - 6 -

Fistula -

AUR/blocked catheter 1 4 -

Intervention – DiagnosticFlexible cystoscopy 2 6 1

GA cystoscopy - 1 2

Intervention - Therapeutic

TURP - 3€ -

BNI - - 1

Weck clip removal 1 - -

Dilatation 2 4 2

Artificial sphincter 1 1 2

Non-surgical

TIA 1 - -

PE 1 - -

Lung cancer - 1 -

Death - 1 (lymphoma) -

*Associated small pelvic collection, not requiring intervention but delaying discharge€ 2 procedures on same patient

In-patient

Stay

Catheter time

(days)

Recurrence rate

Sexual function

Urinary Symptoms

Complications (C)

Diagnostic interventions (D)

Therapeutic interventions (T)

No. of patients

requiring >1 therapeutic intervention

RALPMedian

2(1-4)

Median 14

(10-48)

2 (6.7%)

Earlier return to baseline in HIFU

No significant difference in symptoms

10 (C)7 (D)2 (T)

0

HIFU (Primary)

Day caseMedian

10 (10-24)

7 (28.0%)

22 (C)10 (D)12 (T)

3 (12%)

HIFU (Salvage)

Day caseMedian

10 (7-15)

3 (60.0%)

9 (C)5 (D)9 (T)

3 (60%)

Thank you for your attention