17/12/2014

1

Mr Ben Challacombe MS FRCS (Urol) Consultant Urological Surgeon & Honorary Senior Lecturer

Guy's and St Thomas’ Hospitals and KCL, London, UK

Monday December 1st

Glaziers Hall

Intuitive Surgical

Ethicon/J&J

GSK

Takeda

Active Surveillance

(Robotic) Radical Prostatectomy

Brachytherapy

External Beam Radiotherapy + hormones

Brachytherapy + EBRT (no hormones)

Alternatives: HIFU?

Cryotherapy

Focal Therapy

The components and potential advantages

Robotic surgical systems in the UK

Morbidity of RARP

The oncological outcomes

The functional outcomes

The challenges of robotics

Training and mentoring in robotic surgery

Radical Prostatectomy Issues Cancer control- Margins and PSA Continence Potency Complications Return to normal activity/ general wellbeing- quality of life

©Scardino PT and Kelman J: The Prostate Book, Avery, 2010.

12/17/2014

MSKCC

Time from RP (years)

20151050

1.0

.8

.6

.4

.2

0.0

100%

99%

96%

94%

99%

96%

88%

83%

pT2N0

pT3aN0

95%

98%

pT3bN0

pT1-3 N+

71%

74%

pT2N0

pT3aN0

pT3bN0

pT1-3 N+

Time from RP (years)

20151050

1.0

.8

.6

.4

.2

0.0

91%

16%

73%

38%

pT2N0

pT3aN0

69%

91%

pT3bN0

pT1-3 N+

Probability of Cancer Control (PSA) & Cancer Specific Survival: by pathologic stage

PSA Progression-Free Probability Cancer Specific Survival

Previous Gold standard

Is it MORBID??

Mortality <1%

Blood transfusion 20-30%

Complications 9-30%

Hospital stay 6.4 days

Incontinence <10%

Erectile dysfunction 14-44%

Judge et al. BJUi 2007 Catalona et al. J Urol 2004 Walsh et al. Urology 2000

Graefen et al Eur Urol 2006

17/12/2014

2

Commissioners of urology services should consider providing robotic surgery to treat localised prostate cancer. [new 2014]

robotic systems are cost effective by basing them in centres expected to perform >150 RARPs per year. [new 2014]

• 4 robotic arms enable Solo Surgery™

• Fingertip control

• 7º of freedom 90º of articulation

• Motion scaling and tremor reduction

Enhanced Dexterity, Precision & Control

da Vinci Surgical System

Superior Visualization

Enhanced Dexterity

Greater Precision

Ergonomic Comfort

da Vinci® Surgical System

13

Tyrone

Deny Antrim

Down Armagh

Fermanagh

BELFAST

NORTHERN

IRELAND

Waterford Cork

Kerry

Limerick Tipperary Kilkenny

Wexford

Carlow

Laois

Kildare

Dublin

Meath

Offaly

Westmeath Galway

Mayo Roscommon

Longford

Cavan

Sligo

Leitrim

Donegal

Monaghan

Louth

Clare Wicklow

DUBLIN

IRELAND

Dyfed

Powys

West

Glamorgan

Mid

Glamorgan

Gwent

South

Glamorgan

Clwyd

Gwynedd

Anglesey

WALES

Grampian Highland

Shetland Islands

Mull

Skye

Western

Isles

Orkney

Strathclyde

Lothian

Fife

Tayside

Central

Dumfries And

Galloway

Islay

Borders

GLASGOW

SCOTLAND

Arran

Shropshire

LONDON

Cornwall

Devon

Somerset

Avon

Isle of Wight

Dorset

Hampshire

Surrey

Berkshire

Oxfordshire

Gloucestershire

Greater

London

Hertfordshire

Wiltshire

W. Sussex E. Sussex

Kent

Essex

Suffolk

Norfolk

Cambridgeshire North-

Hamptonshire

Lincolnshire

Cumbria

Humberside

Nottinghamshire

Lancashire

Merseyside

Durham

Tyne & Wear

Cleveland

North

Umberland

Isle Of Man

Leichestershire

Hereford & Worcester

West

Midlands

Warwickshire

Bedfordshire

Bucking-

hamshir

e

Staffordshire

Cheshire Derbyshire

South

Yorkshire

West

Yorkshire

Greater

Manchester

ENGLAND

UNITED KINGDOM

IRELAND

© Copyright Bruce Jones Design Inc. 2003

1999 2000 2001 2002 2003 2004

Alaska

2005

Hawaii

2006 2007 2008 2009

Puerto Rico

2010

Europe

400

USA

1,789

Australia 27

Japan 70 South Korea 36

India 21 China 21

Taiwan 12 Thailand 7

Singapore 5 Malaysia 4 Indonesia 1

Philippines 1

Portugal 1 Slovenia 1

Cyprus 1 Monaco 1

da Vinci Installs by Country and Region

Saudi Arabia 11

Israel 6 Qatar 4

Pakistan 2 Egypt 1

Kuwait 1 Lebanon 1

Middle East 26

Brazil 5 Argentina 4

Chile 4 Venezuela 3

Mexico 3 Colombia 2

Panama 1 Uruguay 1

Latin America

23

Sweden 15 Denmark 11

Norway 9 Finland 5 Austria 4 Ireland 3

Distribution Italy 62

Spain 25 Turkey 16

Czech Rep 12

Direct Germany 60

France 59 Belgium 28

UK 27 Switzerland 18 Netherlands 16

Asia

178

Canada 19

Russia 10 Greece 8

Romania 6 Bulgaria 1

Poland 1

Portugal

Spain

France

Belgium

UK Netherlands

Irish

Republic

Germany

Denmark

Norw ay

Sw eden

Finland

Estonia

Latvia

Lithuania

Poland

Belarus

Sw itzerland

Italy

Czech Republic

Slovakia

Austria

Ukraine

Moldova

Slovenia Croatia

Hungary Romania

Bosnia &

Herzegovina Serbia &

Montenegro Bulgaria

Macedonia

Albania

Greece

Turkey 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

2009

2010

2011 2012

da Vinci ®

European Cumulative Installs 1999 – 2012

Addenbrooke’s Hospital – Cambridge (2)

Broomfield Hospital - Essex

Christies Hospital – Manchester

East Kent Hospital Canterbury

Frimley Park NHS Foundation Trust - Surrey

Guy's Hospital London – London

Lister Hospital – Hertfordshire

Oxford Radcliff Trust - Oxford

Royal Marsden Hospital – London

Royal Berkshire - Reading

Royal Surrey County NHS trust – Guildford

Royal Hospital Liverpool

St. George's Healthcare NHS Trust - London,

St. James’s University Hospital – Leeds

St Mary’s Hospital – School of Medicine – London

South Devon Healthcare NHS Foundation Trust - Devon

The London Clinic – London (2)

The Princess Grace Hospital – London

The Wellington Hospital

Wexham Park Hospital - Berkshire

17/12/2014

3

60 vs 60 pts Italy

No difference in pathology: margins

The continence rate was higher in the RARP group at every time point 3 month 80% RARP, 61.6% LRP (p=0.044)

1 yr 95.0% and 83.3%, respectively (p=0.042).

Among preoperative potent patients treated with nerve-sparing techniques, the rate of erection recovery was 80.0% RARP and 54.2% LRP (p=0.020).

Vickers and Scardino, 2008

Author N= Mean

PSA

(ng/mL)

Mean

operative

time (m)

Mean

blood

transfusio

n (%)

Mean

hospita

l stay

(d)

Overall

positive

surgical

margins

(pT2

margins

) (%)

Continence

(≤1

pad/day)

(%)

Potency

(%)

Mean

follow-

up

(mo)

BCRFs

(%)

Joseph 325 6.6 130 1.3 1 13(9.9) 96 70 N/R N/R

Patel 1500 6.6 105 0 1.1 9.43(4) N/R N/R 53 N/R

Zorn 300 N/R 282 1.7 1.4 20.9

(15.1)

90.2 80 17.3 93.1

Badani 2766 6.4 154 1.5 1.1 N/R(13) 93 79.2 25.8 92.7

Mottri

e

184 8.7 171 0.5 N/R 15.7(2.5) 95 70 6 94.1

Murph

y

400 8.5 186 1.5 2.5 19.2

(9.6)

91.4 64 23 86.6

Cost

Availability

Learning Curve

Training

Case Volume

Team

After RP, RT and Observation

17 SEER registries on 404,604 localised prostate

cancer pts

Cancer-specific and other cause mortality

In low and intermediate risk : RP best

In high risk …

Abdollah F et al. Eur Urol 2011,59:88-95

Abdollah F et al. Eur Urol 2011,59:88-95

RP provides the best survival in all but in the >80y

Abdollah F et al. Eur Urol 2011,59:88-95

• Excellent (better than RRP) perioperative

outcomes

• Equivalent (early and intermediate) oncologic

outcomes

• Significantly better functional (continence and

potency) outcomes

Melbourne, Australia, supported by TUF grant

17/12/2014

4

185 citations

• Search period: from 1999 to 2008

• EMBASE, MEDLINE, Web Science

• 37 comparative studies

Outcomes evaluated

• Perioperative

- operative time, blood loss, transfusion rate,

overall complication rates

• Oncological

- positive surgical margins, bDFS, OS and CSS

• Functional

- urinary continence and potency recovery

Operative time: RARP series

Mean 138 min (90-180)

Blood loss: RARP series

Mean 232 ml (69-534)

Transfusion rate: RARP series

Mean 1.9% (0-5%)

Overall complications: RARP series

17/12/2014

5

Overall complications: RARP Vs RRP

Novara G, Ficarra V. et al (unpuplished data)

Overall complications: RARP Vs LRP

Novara G, Ficarra V. et al (unpuplished data)

Outcomes evaluated

• Perioperative

- operative time, blood loss, transfusion rate,

overall complication rates

• Oncological

- positive surgical margins, bDFS, OS and CSS

• Functional

- urinary continence and potency recovery

PSMs rate in pT2 tumors: RARP series

Mean 12% (4-27%)

Positive surgical margins: RALP Vs RRP

Novara G, Ficarra V.. et al (unpuplished data)

Positive surgical margins: RALP Vs RRP

Novara G, Ficarra V. et al (unpuplished data)

Sensitivity analysis in pT2 prostate cancers

Positive surgical margins: RALP Vs LRP

Novara G, Ficarra V.. et al (unpuplished data)

Oncological Results: 5-year bDFS

Menon M et al Eur Urol 2010; 58: 838-846

95% 91%

86% 81%

Oncological Results: 5-year bDFS

Suardi N, Ficarra V., Mottrie A. et al Urology (in press)

95% 91%

86% 81%

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Oncological Results: bDFS

Sooriakumaran P. et al J Urol 2011; 165: 4 (suppl 1); e 263

20,166 patients having surgery in 15 Centers

Oncological Results: bDFS

Sooriakumaran P. et al J Urol 2011; 165: 4 (suppl 1); e 263

7,543 patients with low risk cancer

Adjusted HR for RARP: 0.77; p = 0.262

Oncological Results: bDFS

Sooriakumaran P. et al J Urol 2011; 165: 4 (suppl 1); e 263

7,387 patients with intermediate risk cancer

Adjusted HR for RARP: 0.77; p = 0.262 Adjusted HR for RALP: 0.64; p = 0.001

Oncological Results: bDFS

Sooriakumaran P. et al J Urol 2011; 165: 4 (suppl 1); e 263

2,969 patients with high risk cancer

Adjusted HR for RALP: 0.64; p = 0.001 Adjusted HR for RALP: 0.68; p = 0.004

Outcomes evaluated

• Perioperative

- operative time, blood loss, transfusion rate,

overall complication rates

• Oncological

- positive surgical margins, bDFS, OS and CSS

• Functional

- urinary continence and potency recovery

Urinary continence recovery: non comparative

RALP series

Mean 92% (83 – 98%)

Urinary continence: RARP Vs RRP

Novara G, Ficarra V., et al (unpuplished data)

12-mo continence rate

Urinary continence: RARP Vs LRP

Novara G, Ficarra V., et al (unpuplished data)

12-mo continence rate

Potency recovery: non comparative RALP

series

Mean 78% (62– 94%)

17/12/2014

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Potency recovery: RARP Vs RRP

Novara G, Ficarra V. et al (unpuplished data)

Potency recovery: RARP Vs LRP

Novara G, Ficarra V. et al (unpuplished data)

12-mo potency rate

Functional Outcomes: limitations

• Major methodological and surgical issues may affect

continence rates (definition, use of questionnaires,

time of assessment, surgical details)

• Most of the available studies do not report

erectile function recovery in the appropriate way

Potential disadvantages of minimally invasive

radical prostatectomy: Costs

Bolenz C. et al. Eur Urol 2010; 57: 453-458

Guy’s Younger Pts <55years

• 236 cases

• Mean age 51 years (range 45- 55years)

• Mean PSA 9.1 (0.5-46).

• T2/T3 positive margin rate of 7.8%/ 27.3%.

• Rate of biochemical free recurrence 96% (4

yrs)

• 220patients (93%) had good erections (IIEF >20)

+/- a PDE5 inhibitor post operatively.

• There were 2 cases of incontinence requiring an

AUS and one male sling (1.27%).

Refining the anatomy

Higher volume surgeons and centres

Better reporting of data

Removing less able surgeons from the field.

Case volume is Key

The robot is here to stay

MIS: Less blood loss/transfusion

Less pain

Earlier Discharge

Faster return to work

At least as good oncological results

Better functional results

Choose your surgeon wisely

Robotics in urology has raised the bar

Patients demand it

High volume results excellent

Can we afford it?

Can we afford not to?