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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
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
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
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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
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ence
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Clin
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Mar
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19(6
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osky
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Inst
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ct 4
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Aug
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bbin
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Int J
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ncol
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s.
2005
Feb
1;6
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: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