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Cryoablation Cryoablation Of The Prostate Of The Prostate Ask Dr Barken Call In Show

Cryoablation Of The Prostate Ask Dr Barken Call In Show

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Cryoablation Cryoablation Of The ProstateOf The Prostate

Ask Dr Barken Call In Show

Cryotherapy DefinedCryotherapy Defined

Cryo = Greek for cold

TherapyTherapy = Greek for healing

Cold Healing

Cryotherapy FeaturesCryotherapy Features

No major incision, blood loss, or radiation

Destroys cancer during the procedure

Dead cells are reabsorbed by the body

Outpatient or overnight hospital stay

Rapid return to normal activity

FDA cleared, Medicare approved

Repeatable procedure

Cryotherapy ProcedureCryotherapy Procedure

Ultrasound used to position probes

6-8 thin cryoprobes inserted in prostate

Circulate argon gas inside probes (-180ºC)

Achieve -40ºC temp throughout prostate

Visually see the process as it happens

Double freeze/thaw destroys cancer

Cryotherapy Cryotherapy TechnologyTechnology

Step #1Step #1

Ultrasound Image CaptureUltrasound Image Capture

Capture live ultrasound image of the prostate

1) Prostate margin 1) Prostate margin 2) Urethra 2) Urethra 3) 3) Denonvilliers FasciaDenonvilliers Fascia

Step #2Step #2

Probe PlanningProbe Planning

OutlineOutline

Step #3

Probe Placement

Under ultrasound probes are placed

Step #

Freezing

Circulating argon gas freezes cancer cells

Cryotherapy Cryotherapy Eligibility and TechniqueEligibility and Technique

Total Prostate FreezeTotal Prostate Freeze• Eligibility

Primary or recurrent prostate cancer patients (following radiation) with moderate to high risk tumors where the goal is complete ablation of the prostate gland.

TechniqueBlue area represents freezing within and beyond gland; small circles indicate computer-determined location of 6 probes.

• OutcomesLow incontinence (<6%), 47% chance of regaining erectile function within 12-36 months as nerves regenerate slowly.

• Eligibility

Primary or recurrent prostate cancer patients (following radiation) with low risk tumors confined to one side where the goal is targeted ablation and avoidance of one or both neurovascular bundles.

TechniqueBlue area shows partial freeze on one side of gland and beyond gland margin on the same side. Opposite side of gland is untreated.

• OutcomesLow incontinence (<1%), 87% chance of maintaining erectile function.

Focal Prostate FreezeFocal Prostate Freeze

Comparison of ALL papers published in the last 5 years (2002-2007) – Radical prostatectomy – Brachytherapy – External beam radiation therapy– 3-D conformal radiation therapy

Comparative Review– Cancer Control (Based on PSA levels)– Morbidity (Side effects)– Quality of Life

Prostate Cryo OutcomesProstate Cryo OutcomesCancer Control & Side EffectsCancer Control & Side Effects

0

20

40

60

80

100

Radical Cryo Brachy Beam RT IMRT Combo

79%1

72%2

89%3

69%4

93%5

63%6

89%7

40%8

94%9

88%10

100%11

92%12

Moderate Risk

0

20

40

60

80

100

Radical Cryo Brachy Beam RT IMRT Combo

94%1

84%2

92%3

65%4

97%5

85%6

93%7

55%8

100%9

97%10

94%11

92%12

Low Risk

1.

Sh

ark

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200

5;4

(1):

34

-44

. 2

. Cie

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347

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ah

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Uro

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3-1

1.

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ahn

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Aug

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(2 S

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3-1

1.

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aw

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Ra

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20

07

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18

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Jan

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Radical Cryo Brachy Beam RT IMRT Combo

69%1

23%2

89%3

64%4

88%5

24%6

81%7

28%8

75%9

70%10

91%11

55%12

0

20

40

60

80

100High Risk

5-year 5-year PSA PSA comparison comparison from all from all literature literature reports reports 2002 - 20072002 - 2007Low-Risk Disease:- PSA10 ng/ml, GG6, and Stage T2a

Moderate-Risk Disease:-One of any of the following:-PSA>10 ng/ml, GG7, or Stage T2b

High-Risk Disease:-2 or 3 of the following:-PSA>10 ng/ml, GG7 or Stage T2b

0

10

20

30

40

50

RadicalProstatectomy

Cryo Brachy External Beam RT

IMRT

8%3

1%4

49%1

5%2

10%5

1%6

7%7

4%8

15%9

0%10

Occ

urr

ence

(%

)

1. S

tein

eck

et a

l, N

Eng

l J M

ed. 2

002

Sep

12;

347(

11):

790-

6; 2

. Abo

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ur J

Sur

g O

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Long

et a

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Mar

;57(

3):5

18-2

3; 4

. Don

nelly

et a

l, U

rolo

gy. 2

002

Oct

;60(

4):6

45-9

; 5. R

eis

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t Uro

l N

ephr

ol. 2

004;

36(2

):18

7-90

; 6. F

eige

nber

g et

al,

Int J

Rad

iat O

ncol

Bio

l Phy

s. 2

005

Jul 1

5;62

(4):

956-

64; 7

. Mat

alin

ska

et a

l, J

Clin

Onc

ol. 2

001

Mar

15;

19(6

):16

19-2

8; 8

. Pot

osky

et a

l, J

Nat

l Can

cer

Inst

. 200

0 O

ct 4

;92(

19):

1582

-92;

9.

Zel

efsk

y et

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Int J

Rad

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Bio

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s. 2

002

Aug

1;5

3(5)

:111

1-6;

10.

Bra

bbin

s et

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Int J

Rad

iat O

ncol

Bio

l Phy

s.

2005

Feb

1;6

1(2)

:400

-8. c

Incontinence

0

20

40

60

80

100

RadicalProstatectomy

Cryo Brachy External Beam RT

IMRT

93%3

53%4

91%1

14%2

51%5

5%6

63%7

41%8

NOTREPORTED

Occ

urr

ence

(%

)

Impotence

Range of published rates (since 2000)

Rectal MorbidityRectal Morbidity

 Severe (fistula)

Moderate(bleeding, urgency,

diarrhea)

Radical Prostatectomy

< 0.5 % 1-19 %

Cryoablation < 0.5 % 0 %

Brachytherapy

 < 0.5 % 4-11 %

Beam radiation  

12-43 %

IMRT   0-25 %

 

Shrader-Bogen Cancer 1997; Talcott J Clin Oncol 1998; Lim Urology 1995; Ragde Cancer 1997; Theodorescu Cancer 2000; Merrick Int J Radiat Oncol Biol Phys 1999; Merrick Int J Radiat Oncol Biol Phys 2000; Donnelly Urology 2002; Long Urology 2001; Zelefsky Radiother Oncol; Brabbins Int J Radiat Oncol Biol Phys. 2005;

Quality of Life ComparisonQuality of Life Comparison

FACT-PSurvey/

AnalysisTool

Reference

24

25

25

26

26

27

CRYO BRACHY SURGERY RADIATION OBSERVATION

Physical Well-Being

18

19

20

21

22

23

24

25

26

CRYO BRACHY SURGERY RADIATION OBSERVATION

Functional Well-Being

12

14

16

18

20

22

24

CRYO BRACHY SURGERY RADIATION OBSERVATION

Social/Family Well-Being

Source: MedReviews Source: MedReviews

Primary CryotherapyASTRO – 3 Successive PSA rises

Source: Cryo On Line Data- RegistryCOLD-Registry: Endocare

1. Low: 84.7%2. Moderate: 73.4%3. High: 75.3%

Primary Cryoablation – Total Gland5-Year Biochemical Survival

Risk Factors (2003 D’Amico) Number of Patients

Percent

Low-Risk = PSA < 10, Gleason < 7, Stage < T2b 273 22.8%

Moderate-Risk = All Others 475 39.7%

High-Risk = PSA > 20, Gleason > 7, Stage >T2b 450 37.6%

Primary Cryotherapy27 Cryosurgeons Nationwide

OutcomesIncontinence @ 12 months:

- 4.8% (any leak whatsoever) - 2.9% (any pad use)

Return to intercourse:

- 16.8% (8.8% no assistance) Fistula: 0.4%

5-Year Biochemical Survival: 77.1%

Patient Demographics Database: 1,198

Age: 69.8 ± 7.5 years

PSA: 9.6 ± 8.6 ng/ml

Gleason: 7 (median)

Source: Cryo On Line Data- RegistryCOLD-Registry: Endocare

Why Consider Cryo

Minimally invasive treatment

No major surgery or radiation

Can fit Gleason grade and tumor stage

Rapid recovery

Availability of “focal Cryo” for nerve sparing

Repeatable

Positive outcome data

Thank You