Transcript The Cold Facts About Cryo - PC-REF

Cryoablation
Of The Prostate
Ask Dr Barken Call In Show
Cryotherapy Defined
Cold Healing

Cryo = Greek for cold

Therapy = Greek for healing
Cryotherapy 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 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
Technology
Step #1
Ultrasound Image Capture
Capture live ultrasound
image of the prostate
Step #2
Probe Planning
Outline
1) Prostate margin
2) Urethra
3) Denonvilliers Fascia
Step #3
Probe Placement
Under ultrasound
probes are placed
Step #
Freezing
Circulating argon gas
freezes cancer cells
Cryotherapy
Eligibility and Technique
Total 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.
Technique
Blue area represents freezing within and beyond gland; small
circles indicate computer-determined location of 6 probes.
Outcomes
Low incontinence (<6%), 47% chance of regaining erectile function
within 12-36 months as nerves regenerate slowly.
Focal Prostate Freeze
•

•
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.
Technique
Blue area shows partial freeze on one side of gland and beyond gland
margin on the same side. Opposite side of gland is untreated.
Outcomes
Low incontinence (<1%), 87% chance of maintaining erectile function.
Prostate Cryo Outcomes
Cancer Control & Side Effects

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
100
5-year
PSA
comparison
from all
literature
reports
2002 - 2007
Low-Risk Disease:
- PSA10 ng/ml, GG6, and
Stage  T2a
Moderate-Risk Disease:
-One of any of the following:
-PSA>10 ng/ml, GG7, or
Stage  T2b
High-Risk Disease:
-2 or 3 of the following:
-PSA>10 ng/ml, GG7 or
Stage  T2b
80
80
60
80
20
94%1
Low Risk
60
Radical
100
79%1
72%2
Radical
100
40
Radical
92%3
84%2
Cryo
89%3
69%4
Cryo
89%3
23%2
Cryo
97%5
40
Brachy
93%5
Brachy
93%7
Beam RT
89%7
Beam RT
81%7
69%1
60
0
24%6
28%8
Brachy
Beam RT
100%9
85%6
97%10
IMRT
Moderate Risk
94%9
88%10
IMRT
88%5
64%4
IMRT
92%12
65%4
55%8
20
0
Combo
100%11
92%12
63%6
40
20
40%8
0
Combo
High Risk
91%11
75%9
70%10
55%12
Combo
1. Sharkey et al, Brachytherapy. 2005;4(1):34-44. 2. Ciezki et al, Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1347-50. 3. Bahn
et al, Urology. 2002 Aug;60(2 Suppl 1):3-11. 4. Bahn et al, Urology. 2002 Aug;60(2 Suppl 1):3-11. 5. Lawton et al, Int J Radiat Oncol
Biol Phys. 2007 Jan 1;67(1):39-47. 6. Kwok et al, Int J Radiat Oncol Biol Phys. 2002 Jul 1;53(3):588-94. 7. Ciezki et al, Int J Radiat
Oncol Biol Phys. 2004 Dec 1;60(5):1347-50. 8. Goldner et al, Strahlenther Onkol. 2006 Sep;182(9):537-42. 9. De Meerler et al
Radiother Oncol. 2007 Jan 11; [Epub ahead of print] 10. Kupelian et al, Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1463-8. 11.
Sylvester et al, Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):57-64. 12. Sylvester et al, Int J Radiat Oncol Biol Phys. 2007 Jan
1;67(1):57-64.
94%11
Incontinence
Occurrence (%)
Impotence
Occurrence (%)
100
50
0
91%1
20
10
5%2
93%3
80
63%7
60
51%5
53%4
40
14%2
0
Cryo
Radical
Prostatectomy
Cryo
Radical
Prostatectomy
Brachy
NOT
REPORTED
41%8
5%6
External
Beam RT
20
IMRT
49%1
40
30
15%9
8%3
10%5
1%4
1%6
4%8
0%10
Brachy
External
Beam RT
IMRT
7%7
1. Steineck et al, N Engl J Med. 2002 Sep 12;347(11):790-6; 2. Abou-Elela et al, Eur J Surg Oncol. 2007; 33:96-101; 3.
Long et al, Urology. 2001 Mar;57(3):518-23; 4. Donnelly et al, Urology. 2002 Oct;60(4):645-9; 5. Reis et al, Int Urol
Nephrol. 2004;36(2):187-90; 6. Feigenberg et al, Int J Radiat Oncol Biol Phys. 2005 Jul 15;62(4):956-64; 7. Matalinska
et al, J Clin Oncol. 2001 Mar 15;19(6):1619-28; 8. Potosky et al, J Natl Cancer Inst. 2000 Oct 4;92(19):1582-92; 9.
Zelefsky et al, Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1111-6; 10. Brabbins et al, Int J Radiat Oncol Biol Phys.
2005 Feb 1;61(2):400-8. c
Range of published rates (since 2000)
Rectal Morbidity
Severe
(fistula)
Moderate
(bleeding, urgency,
diarrhea)
Radical
Prostatectomy
< 0.5 %
1-19 %
Cryoablation
< 0.5 %
0%
Brachytherapy
< 0.5 %
4-11 %
Beam radiation
IMRT
12-43 %
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 Comparison
27
Physical Well-Being
26
26
FACT-P
Survey/
Analysis
Tool
Reference
25
25
24
CRYO
BRACHY
SURGERY
24
RADIATION
OBSERVATION
Social/Family Well-Being
22
20
18
16
14
12
CRYO
BRACHY
SURGERY
RADIATION
OBSERVATION
26
Functional Well-Being
25
24
23
22
21
20
19
Source: MedReviews
18
CRYO
BRACHY
SURGERY
RADIATION
OBSERVATION
Primary Cryotherapy
ASTRO – 3 Successive PSA rises
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%
Risk Factors (2003 D’Amico)
Primary Cryoablation – Total Gland
5-Year Biochemical Survival
1. Low:
2. Moderate:
3. High:
Source: Cryo On Line Data- Registry
COLD-Registry: Endocare
84.7%
73.4%
75.3%
Primary Cryotherapy
27 Cryosurgeons Nationwide
Patient Demographics
Database: 1,198
Age: 69.8 ± 7.5 years
PSA: 9.6 ± 8.6 ng/ml
Outcomes
Incontinence @ 12 months:
- 4.8% (any leak whatsoever)
- 2.9% (any pad use)
Return to intercourse:
- 16.8% (8.8% no assistance)
Gleason: 7 (median)
Source: Cryo On Line Data- Registry
COLD-Registry: Endocare
Fistula: 0.4%
5-Year Biochemical
Survival: 77.1%
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