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 RALPHIFU N3025 (Primary)5 (Salvage) Age (yrs) § Median (range)60 (42-74)67 (51-78)71 (61-79) Presenting PSA (ng/dL)* Median (range)7.0 ( )6.6 ( )6.0 ( ) Gleason score* ≤ = >7210 Unknown093∞3∞ T stage* T1c530 T2a641 T2b220 T2c1442 T3a000 T3b000 Unknown3122 Pre-treatment hormones 141 § 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 RALPHIFU (Primary)HIFU (Salvage) Length of stay (days)Median (range)2 (1-4)11 Catheter type U = urethral SP = suprapubic 30 U 3 SP 22 U 1 SP 4 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 RecurrenceRALP HIFU PrimarySalvage N30255 PSA € 273 ASTRO∞-73 Phoenix*-83 Re-Biopsy-31 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 treatment Relapsed RALP HIFU (Primary) HIFU (Salvage) Total273 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 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 months 1 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

Complications ComplicationRALP HIFU (Primary) HIFU (Salvage) Anastomotic leak1*-- Stricture24- Infection131 Debris passage-6- Fistula- AUR/blocked catheter14- Intervention – Diagnostic Flexible cystoscopy261 GA cystoscopy-12 Intervention - Therapeutic TURP-3€3€ - BNI--1 Weck clip removal1-- Dilatation242 Artificial sphincter112 Non-surgical TIA1-- PE1-- 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) Recurr ence rate Sexual function Urinary Symptoms Complications (C) Diagnostic interventions (D) Therapeutic interventions (T) No. of patients requiring >1 therapeutic intervention RALP Median 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 case Median 10 (10-24) 7 (28.0%) 22 (C) 10 (D) 12 (T) 3 (12%) HIFU (Salvage) Day case Median 10 (7-15) 3 (60.0%) 9 (C) 5 (D) 9 (T) 3 (60%)

Thank you for your attention