The Role HIFU

1
The Role HIFU Cryosurgeryin the Treatment of
Prostate Cancer
The Prostate Cancer Research Education
Foundation Web Cast Presentation From Alvarado
Hospital San Diego, California

• Douglas Chinn MD
• Chinn Chinn Urology Associates
• Arcadia, CA

2
(No Transcript)
3
(No Transcript)
4
HIFU Cryosurgery

• Can treat all risk groups
• Very low risk of incontinence Primary
• Low risk of incontinence Salvage
• Moderate impotency rate
• Can be repeated
• Can treat radiation failures
• Can treat Seminal Vesicles

• Can treat all risk groups
• Very low risk of incontinence Primary
• High risk of incontinence Salvage
• High impotency rate
• Can be repeated
• Can treat radiation failures
• Can treat Seminal Vesicles

5
Prostate CryosurgeryProcedure

• Utilizing ultrasound and temperature monitoring,
  the cryoprobes are sequentially activated,
  encasing the entire prostate in lethal ice.

6
Cryosurgery 9-Year Actual BFRSHigh Risk Patients
7
WHAT IS HIFU?
High Intensity Focused Ultrasound
Courtesy Focus Surgery
8
HIFU Energy Delivery High Intensity Focused
Ultrasound
9
Ablatherm Sonablate 500
10
Ablatherm Sonablate
11
Ablatherm Sonablate 500
12
Ablatherm Sonablate 500
13
Ablatherm Sonablate 500
14
Sonablate 500 Ablatherm
15
HIFU

• HIFUs robotic computer control provides very
  precise tissue targeting

16
Biochemical Disease Free Rates by PSA
Risk Group bDFS Uchida1 bDFS Lee3
Low Risk 84 85
Moderate Risk 69 77
High Risk 51 47
17
OUTCOME DATA
Poissonnier Chaussy Thuroff Vallancien Blana Lee
Number of patients 227 271 402 30 146 58
Study Dates 1994-2003 1995-1999 1999-2001 1997-2002 2004-2005
Mean follow-up 27 mos 19 mos 13 mos 20 mos 22 mos 14 mos
Negative biopsy rate 86 85 87 80 93
Mean PSA .49 1.8
Median PSA 0.10 0.0 0.6 0.9 0.15 0.6
18
HIFU Outcome DataBlana et al 2007
19
(No Transcript)
20
OPTIONS Radiation Failure

• Salvage Radical Prostatectomy
• Salvage Cryosurgery
• Salvage HIFU

21
OPTIONS Radiation FailureTotal Incontinence

• Salvage Radical 40-60
• Salvage Cryosurgery 40-50
• HIFU 7

22
(No Transcript)
23
Obstruction and Slough

• Both HIFU and cryosurgery have retention of urine
  immediately after treatment.
• Both require a catheter or suprapubic catheter

24
Obstruction and Slough

• Slough is common with HIFU, only about 15 with
  cryosurgery
• Caused by HIFU of urethra
• Currently no protective cooling catheter vs
  cryosurgery
• Can cause infection and blockage

25
Obstruction and Slough

• Avoid the urethra Avoid slough
• Will have untreated tissue
• May have recurrence of Cancer
• Treat up to the sides of the urethra
• Warming catheter with cryosurgery may protect
  cancer near the urethra

26
Normal Prostatic Urethra
27
Obstruction
28
Transurethral Resection of the Prostate TURP

• Scraping out the center of the prostate gland
• Used only in HIFU, not Cryosurgery
• TURP minimizes the obstruction caused by
  sloughing
• TURP minimizes the obstruction caused by scar
  tissue

29
TURP
30
(No Transcript)
31
Post HIFU Outlet Obstruction Slough Poissonnier
2006

• NO TURP 31
• Pre HIFU TURP 6

32
Post HIFU Outlet Obstruction Blana, et al 2007

• 315 Patients
• 25 (79) developed obstruction
• 6 (19) developed recurrent obstruction
• 30 (of the 79 patients) had urethral slough
• Prostatic urethra/bladder neck stenosis was the
  most common cause

33
Post HIFU Outlet Obstruction Blana, et al 2007

• Age (gt70 yrs) was the only significant factor in
  the development of obstruction
• TURP significantly lowered the rate of recurrent
  obstruction

34
Post HIFU Outlet Obstruction CONCLUSION

• TURP shortens immediate post HIFU catheterization
  time down to 5-7 days
• TURP decreases the obstructive symptoms of slough
• TURP significantly lowered the rate of recurrent
  obstruction

35
(No Transcript)
36
The Spanner

• Temporary prostatic stent
• Can be easily placed and removed, all in the
  office setting
• Can be easily replaced
• FDA approved, not covered by all insurance
  carriers

37
(No Transcript)
38
The Spanner

• Alleviates immediate obstruction after
  HIFU/Cryosurgery
• May prevent scar tissue formation
• May prevent recurrent scar tissue formation
• Can be used long term for patients with long term
  HIFU scar tissue recurrence

39
The Spanner Advantages

• Much more comfortable and convenient than a
  penile urethral catheter
• No limit to any activities
• Can be sexually active with Spanner in place
• No drainage bags are required

40

• Chinn Chinn Urology has initiated 2 small pilot
  studies to evaluate the use of the Spanner in
  HIFU

41

• Trial 1 Placement of the Spanner Immediately
  post HIFU
• Trial 2 Long term placement of the Spanner for
  post HIFU scar tissue

42
The Spanner Pilot Study

• www.chinnurology.com
• Tel [phone]
• Fax [phone]

43
Radical Prostatectomy

• Surgery NEVER improves Urinary Continence or
  Erectile Dysfunction
• Professor Pierre Teillac, EAU 2006

44
Incontinence Defined (L. Poissonnier)

• Grade 1 Loss of urine during heavy exercises
  but only one pad per day
• Grade 2 Loss of urine during light exercises
  but not at rest or sleep
• Grade 3 Total loss of urine

45
Incontinence HIFU
Type I Type 2 Type 3
Blana n223 7.6 0.2 0
Poissonnier 7 2 0
46
Potency
47
FOCAL THERAPY Preserve Sexual Function
gland edge
48
Impotence
HIFU
Cryosurgery

• Can be avoided
• However, there are some risks
• Sparing tissue High chance of potency
• Treating to edge Risk of impotency
• Small volume disease spare more tissue
• Large volume disease spare little or no tissue
• Risk of sparing Cancer

• Can be avoided
• However, there are some risks
• Sparing tissue High chance of potency
• Treating to edge High risk of impotency
• Small volume disease spare more tissue
• Large volume disease spare little or no tissue
• Risk of sparing Cancer

49
Potency HIFU Total Gland Ablation

• Able to penetrate partner without any medications
• The most recent published data by Blana (World J.
  Endo) states 49.8 impotency as defined above.

50
Potency Cryosurgery Total Gland Ablation

• Expect 100 Impotency

51
FOCAL THERAPYAvoids the Risks of Standard Therapy

• Impotence
• Incontinence
• Decrease recovery time
• Urinary obstruction

52
FOCAL THERAPY Scardino et al EAU 2006

• Focal ablation of low risk prostate cancers with
  minimally invasive techniques is reasonable and
  promising
• Focal ablation may offer important advantages
  over watchful waiting or radical local therapy

53
FOCAL THERAPYDOWNSIDES

• Under staging, resulting in under treatment and
  repeat therapy
• What is the long term effect on leaving small
  multiple foci of cancer?
• Are MRI, biopsies and PSA accurate and reliable
  enough?

54
Focal HIFU
55
SUBTOTAL GLAND ABLATION
56
SUBTOTAL GLAND ABLATION

• Treat the majority of the gland
• Avoid treating the posterior lateral edges of the
  prostate
• Preserves the neurovascular bundle
• Cryosurgery unilateral
• HIFU can be bilateral

57
SUBTOTAL GLAND vs. FOCAL ABLATION

• Less potential of leaving non index cancer behind
• Kill more tissue ? kill more cancer
• Less chance of repeat treatment
• No change in potency rate

58
SUBTOTAL GLAND vs. FOCAL ABLATION

• Slight increase risk of incontinence
• Cryosurgery risk is really low
• HIFU slight increase risk of stress incontinence

59
SUBTOTAL GLAND vs. FOCAL ABLATION

• Cryosurgery longer postoperative recuperation
• HIFU less postoperative recuperation

60
Focal Cryotherapy
Iceball
Iceball
Cryoprobe
Cryoprobe
Untreated tissue
Neurovascular bundle
Neurovascular bundle
61
Subtotal Cryotherapy
Iceball
Iceball
Cryoprobe
Cryoprobe
Untreated tissue
Neurovascular bundle
Neurovascular bundle
62
Subtotal HIFU
63
FOLLOW UP

• PSA biannually
• Prostate biopsy annually
• PCA3 biannually (focal vs. subtotal)

64
THE BIG QUESTIONS

1. Is Focal Therapy curative or just a temporary
   reprieve?
2. Does Subtotal Ablation decrease the odds of
   retreatment?
3. With proper post treatment surveillance, will the
   window of curability remain the same or decrease?

65
(No Transcript)
66
FDA Phase III Clinical TrialCryosurgery vs. HIFU

• To prospectively compare clinical outcome data
  between Cryosurgery HIFU
• EDAP (Ablatherm) is involved in this trial
• Chinn Chinn Urology is actively recruiting
  patients for the cryosurgery arm of this study

67
www.chinnurology.com 626-574-7111
68
FDA Phase III Clinical TrialOverview Patient
Criteria

• Stage T1c-T2a
• No prior definitive therapy
• PSA lt 10
• Gleason lt 7
• No prior Androgen blockade i.e. Lupron
• No Proscar/Avodart within 90 days
• Re-biopsy may be necessary

69
(No Transcript)