American Urological Association Education and Research, Inc.

2008 Annual Meeting, Orlando, FL May 17-22, 2008

RE-ENTRY PASS Sponsored by: The American Urological Association Education and Research, Inc.

COURSES 03 DL

FACULTY

Yair Lotan, M.D. Course Director

Edouard J. Trabulsi, M.D.

John F. Ward, M.D.

Prostate Ultrasound

Saturday, May 17, 2008 10:30 a.m. – 1:30 p.m.

American Urological Association Education and Research Inc.

2008 Annual Meeting, Orlando, FL May 17-22, 2008

Sponsored by: The American Urological Association Education and Research, Inc.

COURSES 03 DL

FACULTY

Yair Lotan, M.D.

Course Director

Edouard J. Trabulsi, M.D. John F. Ward, M.D.

Prostate Ultrasound

Saturday, May 17, 2008 10:30 a.m. – 1:30 p.m.

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2008 AUA Annual Meeting

03 DL Prostate Ultrasound 5/17/2008 10:30 a.m.- 1:30 p.m.

Disclosures According to the American Urological Association’s Disclosure Policy, speakers involved in continuing medical education activities are required to report all relevant financial relationships with any commercial interest to the provider by completing an AUA Disclosure Form. All information from this form is provided to meeting participants so that they may make their own judgments about a speaker’s presentation. Well in advance of the CME activity, all disclosure information is reviewed by a peer group for identification of conflicts of interest, which are resolved in a variety of ways. The American Urological Association does not view the existence of relevant financial relationships as necessarily implying bias, conflict of interest, or decreasing the value of the presentation. Each faculty member presenting lectures in the Annual Meeting Instructional or Postgraduate, MC or EC and Dry Lab Courses has submitted a copy of his or her Disclosure online to the AUA. These copies are on file in the AUA Office of Education. This course has been planned to be well balanced, objective, and scientifically rigorous. Information and opinions offered by the speakers represent their viewpoints. Conclusions drawn by the audience members should be derived from careful consideration of all available scientific information. The following faculty members(s) declare a relationship with the commercial interests as listed below, related directly or indirectly to this CME activity. Participants may form their own judgments about the presentations in light of full disclosure of the facts. Faculty Disclosure Yair Lotan, M.D. Course Director Nothing to disclose Edouard J. Trabulsi, M.D. Intuitive Surgical: Meeting Participant or Lecturer John F. Ward, M.D. Nothing to disclose

Disclosure of Off-Label Uses

The audience is advised that this continuing medical education activity may contain reference(s) to unlabeled or unapproved uses of drugs or devices. Please consult the prescribing information for full disclosure of approved uses. Faculty and speakers are required to disclose unlabeled or unapproved use of drugs or devices before their presentation or discussion during this activity. A special AUA value for your patients: www.UrologyHealth.org is a joint AUA/AFUD patient education web site that provides accurate and unbiased information on urologic disease and conditions. It also provides information for patients and others wishing to locate urologists in their local areas. This site does not provide medical advice. The content and illustrations are for informational purposes only. This information is not intended to substitute for a consultation with a urologist. It is offered to educate the patient, and their families, in order for them to get the most out of office visits and consultations.

Yair Lotan, M.D.Assistant Professor

of Urology

Louis L. Pisters, M.D.Professor of Urology

Edouard J. Trabulsi, M.D.

Assistantof Urology

The University ofTexas Southwestern

Medical Center at Dallas

MD Anderson Cancer Center Houston,

Texas

Assistant Professor of

Urology

Thomas Jefferson University

Principles of Transrectal UltrasoundNormal and Abnormal Anatomic FindingsProstate Biopsy Techniques and Practical PointsPointsPractical Applications;

Fiducial PlacementBrachytherapyCryotherapy

Ultrasound waves are mechanical waves

Like other mechanical waves, ultrasound waves need a medium to be transmitted

The most commonly used transducers range from 3.5 MHz to 10 MHz depending on the application

The transducer has a dual function as a sender and receiver

Reflected mechanical sound waves are received by the transducer and converted back into electrical energy

The electrical energy is converted into a picture on the screen

The scan head acts as receiver > 99% of the time

Pulse duration or pulse “ON” time

Li t tiListen time orpulse “OFF” time

TIME

Total cycle time orpulse repetition period

Attenuation refers to the weakening of ultrasound waves as they travel through the body

Attenuation is due to the following interactions:reflectioni t f interference absorption (conversion to heat)scatteringdivergence

Reflection and RefractionReflection and Refraction

M di 1M di 1

Incident wave

ReflectedΘi Θr

Medium 1Medium 1

Medium 2Medium 2

wave

Transmittedand refracted wave

Θ

t

R R

Prostate(transaxial view)

Principle of Image GenerationPrinciple of Image Generation

T

R R R R

Axial ResolutionAxial ResolutionAxial resolution refers to the ability to identify (as separate) two objects in the direction of the traveling sound wave

Depends on the frequency of sound waves

Higher frequency= better axial resolution

Lateral resolution refers to the ability to identify (as separate) objects which are equidistant from the transducer but spaced apart

Lateral resolution is a function of the focused width of the sound wave beam

The more focused the beam, the better the lateral resolution (i.e. even closely spaced objects can be differentiated)

Most transducers have a: focal point (producing the best lateral resolution) focal range (producing adequate resolution) Focal

Point

FocalRange

A narrow focal range limits the ability to image large organs

Point

Direction of scanDirection of scan

TransducerTransducerImageImage

PointtargetsPoint

targets

Ultrasoundbeam

Ultrasoundbeam

Image ofpoint

targets

Image ofpoint

targets

3 mHz

7 mHz

Transducer

10 mHz

0

2

4

6

8

2 4 6 8 10 12 14 16

Maximum Range in cmMaximum Range in cm

Reverberation

Edging artifact

Axial distortion (refraction artifact)

P i l i ifPropagation velocity artifact

1

23

4

TransducerTransducerImageImage

Refractedbeam

Target

. . . . . . . . . . Imageoftarget

Correctlocationof target

Edging.avi

TransducerTransducer ImageImage

Linear StructureLinear Structure

Low velocityLow velocity

Distorted linear structureDistorted linear structure

The boundaries between different tissues in the body can be seen because of impedance differences.

If th diff i i d i l If the difference in impedance is large, significant amount of ultrasound energy will be reflected back and not through-transmitted (loss of energy and penetration)

If the difference in impedance is very large, all ultrasound energy will be reflected, and no through-transmission will occur (shadowing behind the object with high or low impedance, loss of any imaging capability)

In general, the relatively small difference in impedance between soft tissues allows tissue differentiation

Density ImpedanceAir & other gases 1.2 0.0004 Water & other clear liquids 1000 1.48 Avg of soft tissues 1060 1.63 Muscle 1080 1.70 Liver 1060 1.64 Fat tissue 952 1.38 Bone & other calcified objects

1912 7.8

The appearance of tissue in the body is aconsequence of:

the tissue composition

h i h i f ithe various mechanisms of attenuation

the impedance difference between the target tissue and the surrounding tissues

Description of Ultrasound Images

Many comparable urology specific devices are availableEnd- or sidefire probes with 5 – 8.5 MHz frequencyq yHigher frequency – better resolutionDifferences end- vs sidefire:

Slightly different volume measurementsDifferent aim of needle into prostateMostly preference of physicianNo convincing evidence of different cancer yield

Monitor

Printer (Thermal)

KeyboardTransducer Bay

Printer (Thermal)TransducerPlugs

Wheel forportability

1. Gain

2. Time-gain compensation

3. Frequency

4. Focal zone

5. Depth / size

6. Cine function

“ To produce a good quality image.”

1. Sufficient and uniform brightness

2. Sharp and in focus

3. Adequate size

4. Oriented and labeled for documentation

Appropriatefocal zonesUniform

tissue

Kidney - Adequate size

Kidney, right long

Labeled

Orientation & identification

tissue echogenicity

Kidney, right long

TGC Curve

Activeprobe

Frequency Gain

Focal zones

Dynamicrange

Frame rateMagnification

Depth of field (16 cm)

Focal zonesout ofout of

position

Side and sitenot labeled

Definition:

A control mechanism for varying thesensitivity of the transducer toreturning ultrasound waves.

RENAL CYST

GAIN

Insufficient GainInsufficient GainExcessive GainExcessive Gain

Gain default with orientation change

Definition:

A control to allow variation in the size or depthof a displayed image.

Physics:

Selecting some portion of the availabledata from an ultrasound examinationfor display.

Physics:

Appropriate depth depends on the purpose of the exam.

Decreasing depth may, in some cases, make interpretation of data more difficult.

*

Essential elements• Patient identification (Name/DOB)• Date of procedure• Indication for procedure • Type of procedureyp p• Providers (ordering / performing)• Equipment used*• Findings• Images

Medicare guidelines:Technical quality of ultrasound exam must:

Be in keeping with accepted national standardsNot typically require a follow-up testBe performed and interpreted by qualified individuals

Medical necessity, images, findings, interpretation and report must be documented in the medical record

Ultrasound examinations: Abdominal and retroperitoneal U-15A-R1 (contractor determination number U-15 (L18363) Trailblazer Health Enterprises)http://www.trailblazerhealth.com/lmrp.asp?ID=2270&Imrptype=partaEffective: 4/21/05

• Separate report (Medicare guidelines)• Patient Identification: Patient ID/DOB, ordering

physician, performing provider, date• Indication for procedure• Equipment used: Machine, probe used• Type of examination• Description of findings / comparison with previous

studies• Diagnosis / Impression• Signature of performing provider

Levels of disinfection• Low level: non-critical items; will come in contact with

skin• Intermediate: some critical items and non-critical items• High level: semicritical items; come into contact with

mucous membrane or nonintact skin

Disinfection of Probes

• Critical: will enter tissue or vascular system or blood will flow through them

Consult manufacturer regarding specific recommendations

Consistent techniqueDocumentation of findings• Summary• Images

Summary

Patient safety and equipment maintenance• Disinfection of probes

Note: Videotapes available from AUA Office of Education

Procedure CPT NationalTRUS 76872TRUS guidance 76942Prostate biopsy 55700Scrotal 76870 $90 44

$463.07

2006 Medicare Fees for Office US

Scrotal 76870 $90.44RP complete 76770 $112.15Renal 76775 $83.21Pelvic complete 76856 $92.97Bladder 76857 $82.85PVR 51798 $15.19

*Reference: http://auacodingtoday.com4.4% from 2005

Lateral gland margin Neurovascular bundleSymmetrySeminal vesiclesBiopsy

Base and apexUrethraEjaculatory j yductsSeminal vesiclesConfirm a lesionBiopsy

TRANSVERSE VIEWZONAL ANATOMY AND CALCIFICATIONS

Transition Zone

Peripheral Zone Calcifications

LONGITUDINAL VIEWANATOMICAL LANDMARKS

Bladder

Transition Zone

Urethra

VerumontanumSem. Ves.Peripheral Zone

Ejac. duct

transverse sagittalGleason 7left side

Transverse bladder sagittal

Ductal Ectasia vs. SV Cyst Mullerian Duct Cyst

Sagittal midline Transverse

Contour Changes in Prostate Cancer

• Focal bulge– capsular bulge

• Irregular margin– capsular invasion

• Loss of periprostatic fat

AdenoCa in Left mid

sagittaltransverse Gleason 9 withcapsular invasion

Gray Scale: echogenic cancer

Transversemid-gland sagittalIntraductal cancer

Gleason pattern 3

Transverseapex

Transverse

Sagittal

Post-Prostatectomy

• Smooth anastamosis• Post-op changes in

bladder neck

transverse sagittalPost-radical prostatectomy

Gleason 7 lesion, left mid-gland ProstatitisGleason 7-9 diffusely

Doppler of Prostate Cancer

Gleason 7, Left baseGleason 6, Right base

EJ duct cyst ? Cause or result of obstruction

1213037

• Obstructed Right SV

• Absent Left SV• EJ ducts not found

Ductal ectasia or dilatation may be related to ejaculatory duct obstruction

3371043

Ultrasound Findings of BPH

• Increased inner gland: bi-lobed• Increased Doppler flow

Fleet or other enema is recommended (no or limited evidence)Lateral decubitus position is preferred (to avoid interference from air bubbles rising to

f b ll )top of water balloon etc)Antibiotic prophylaxis is recommended (strong evidence)Periprostatic infiltration with 1 or 2% lidocaine is recommended for pain control and comfort management (strong evidence)

Randomized, placebo controlled studies haveclearly demonstrated the efficacy and cost-effectiveness of various schemes of antibioticprophylaxis prior to TRUS guided biopsiesAntibiotic prophylasis should be part of thestate of the art of TRUS guided biopsy

Rectal wall is a good absorptive surface10cc of 2% lidocaine gel intrarectally instilled 10 min before the procedure has been shown to reduce pain and discomfort IInferior hypogastric plexus at the tip of the seminal vesicles can be infiltrated with 10 ml of 1% aqueous lidocaineUse long spinal needle, pass through needle guide of TRUS probe, infiltrate under direct visual control into nerve bundlesWait 5-10 min for effect to take place, then proceed with TRUS biopsies

(A) Infiltration of plane between rectal wall and prostate, demonstrating development of hydrodissection space (shaded area). (B) Infiltration of nerve plexus of prostate adjacent to seminal vesicle. (C) Infiltration of apical region of prostate at genitourinary diaphragm

5

25

70

HyperIsoHypo

5

20

75

CentralTransitionPeripheral

Staging by TRUS is very unreliable and does not provide information useful for clinical decision makingSimilarly, staging by CT and MRI is too unreliable as a basis for clinical decision unreliable as a basis for clinical decision makingBiopsies guided into the seminal vesicle may give information regarding their involvementThe grade found by TRUS biopsy may or may not be representative for the cancer

Poorly differentiated

Well / moderate

Author/Source Population

2nd bx. 3rd bx.

+ / total % + / total %Keetch et alJ Urol 151: 1571, 94

Screening Yearly f/u 88/427 19 16/203 8

Roehrborn et alUrology 47: 347, 96

Clinic Select 28/123 23 2/22 9

Ukiruma et alUrology 50: 66, 97

ClinicSelect 33/193 17 14/54 26

Fleshner et alJ Urol 158: 505, 97

ClinicSelect 39/130 30 — —

Rietberger et al Screening/Rietberger et alJ Urol 160: 2121, 98

Screening/EORTC 49/442 11 — —

Letran et alJ Urol 160: 426, 98

ClinicPSA 2-15 ng/ml 15/51 29 — —

Borboroglu et alJ Urol 163:158. 00

ClinicSelect 17/57 30 — —

Djavan et alJ Urol 163: 1144, 00

PSA 4-10 ng/mlAll had 2nd TRUS 83/820 10 — —

Gerard et alUrology 55: 553, 00

ClinicSelect 1637/6380 25.7 — —

Slawin et alJ urol 165: 1554, 01

ClinicSelect 27/111 24.3 — —

Stewart et alJ Uruol 166:86, 01

ClinicSelect 77/224 34 — —

An increase in the number of cores leads in general to an increase in the cancer detection rateFor the same number of cores, strategies with a ghigher detection rate

Use more laterally directed biopsies of the PZEmphasize base and apex more than mid-gland biopsiesUse TZ biopsies in larger glands

Increasing Prostate Cancer Detection Rates with Extended Core Biopsy Protocols

Study No. of Cores Cancer Detection Rate

Eskew, 1997 613

23%40%

Naughton, 2000 612

26%27%

Presti, 2000 68

10

33%39%40%

Babaian, 2000 611

20%30%

De la Taille, 2003 6121821

22%28%30%31%

Extended Core Biopsy Techniques

A. B. C.

A1 S t t H d 10 C P ti 2000 12 C (D bl

x x

D. E.

A1 Sextant, Hodge, 1989

10 Core, Presti, 2000 12 Core, (Double Sextant)

13 Core, Eskew, 1997 11 Core, Babaian, 2001

x T2 biopsy

Why perform a saturation biopsy?Who is a Candidate?

• To diagnose cancer. (patients with abnormal or rising PSA or worrisome DRE who have already undergone one or more negative extended biopsies)extended biopsies)

• To determine extent of cancer in patients with a positive extended biopsy. (patients considering observation or focal cryotherapy)

• To assess local control in patients treated with initial radiation or cryotherapy.(patients with rising PSAs after radiation or cryotherapy)

Saturation Prostate Biopsies - Technique

• Position

•Dorsal lithotomy position (perineal)

•Lateral (transrectal)

• General anesthesiaGeneral anesthesia

• Grid (synchronize to TRUS image)

• Biopsy at grid coordinates

• Pull back according to length of prostate and length of biopsy needle. (18 gauge needle / 18mm biopsy core)

Cancer Detection on Repeat Biopsy

Sextant*† Saturation Biopsy‡§

1 prior biopsy 10-17% 36%

2 i bi i 5 14% 31%

** Data adapted from Roehl et al (2002).†† Data adapted from Djavan et al (2001a).‡‡ Data adapted from Stewart et al (2001).§§ Data adapted from Fleshner and Klotz (2002).

2 prior biopsies 5-14% 31%

3+ prior biopsies 4-12% 14-36%

Saturation Biopsies - Complications

• Bleeding

– Perineal pressure reduces risk of perineal bruising / hematomaperineal bruising / hematoma

– Hematuria

– Hematospermia

• Infection

• 2% risk

Saturation Biopsy - Conclusions

1. SB’s can improve cancer detection in patients with a prior negative extended biopsy.

2. SB’s can be used to localize cancer and determine cancer extent in patients considering observation or local cryotherapy

3. SB’s are very useful in the evaluation of patients with rising PSAs after initial radiation therapy or cryotherapy.

Gold markers99.95% ASTM B562-95 (1999)

Pre-cut5.0 x 1.1 mm

SterilizedPackaged

Sets of three

Patient preparationSimilar to that for prostate biopsy

Prophylactic antibioticCleansing enemaAnticoagulation medications are held

Preparation of the introducers

Three Bard 18 Gauge by 20 cm long brachytherapy seed

d i l strand implant needlesBone wax applied to the distal endGold marker loaded using stylet

Left lateral decubitus positionProstate imaged and measured3 mL of 1% lidocaine injected bilaterallyinjected bilaterally3 markers placed at the apex and left and right base

Planning CT

Portal Images

Patient Selection for I-125 Seed Implant

1. Cancer Issues:• Disease confined to prostate• Stage: T1, T2A, early T2B• Grade: Gleason 2-6/10• PSA: < 10 ng/ml

2 Prostate Issues: important for morbidity2. Prostate Issues: important for morbidityA. Relative contraindications:

• Volume > 70 cc• Very large TURP defect• Marked obstruction symptoms (IPSS score >15)

B. Ideal patient:• Gland < 50 cc• Intact prostate• Peak urinary flow rate > 10 cc/sec

Hexagonal Magazine Head

Needle Receptor Release Button

MICK 200-TPNeedle Receptor

Seeds are stacked parallel on top of each other.

Cartridge

General/spinal anesthesia, patient supine.

Needle guide template mounted against the perineum, hollow needles inserted through the template into prostate.

Needle position checked with ultrasound/fluoroscopy and reinserted and/or template repositioned, etc.

Cystoscopy performed at completion of implant, during same anesthesia.

Post-implant CT for dosimetry and implant evaluation.

Identification of Urethra on TRUS with Foley catheter

Sagital Transverse

Foleycatheter

Pre-implant planfor

160 Gy (16,000 rads)I-125 dose coverage

Planning for permanent prostate implantSoftware Template superimposed on prostate

g

Prostate contour160 Gy isodose line

Rectum

Urethra

Seed/needle utilized on current image (red), adjacent image (blue)

Anterior view

Cube-cut view

Axial view

with 3-D image of

prostate (red)

showing

Planning for permanent prostate implantEvaluation of pubic arch interference (PAI/PAO)

showing

pubic arch (yellow)

interference

Reduction of Pubic Arch InterferencePre - LHRH Monotherapy Post - LHRH Monotherapy

Planning for permanent prostate implant

3-D image of

prostate (red),

urethra (green)urethra

and prescribed dose

for Iodine-125

implant

(160 Gy = 16, 000

rads)

apexbase

Operating room setup

Wallner, K. Brachytherapy made complicated

urethral marker

rectal marker

pubic symphysis

Lateral scout view

Axial CT image

rectal marker

urethral marker

AP scout view

Transrectal ultrasound axial images

Prostate Brachytherapy using Transrectal Ultrasound

Needle

Prostate

An increase in the number of cores leads in general to an increase in the cancer detection rateFor the same number of cores, strategies with a ghigher detection rate

Use more laterally directed biopsies of the PZEmphasize base and apex more than mid-gland biopsiesUse TZ biopsies in larger glands

Increasing Prostate Cancer Detection Rates with Extended Core Biopsy Protocols

Study No. of Cores Cancer Detection Rate

Eskew, 1997 613

23%40%

Naughton, 2000 612

26%27%

Presti, 2000 68

10

33%39%40%

Babaian, 2000 611

20%30%

De la Taille, 2003 6121821

22%28%30%31%

Extended Core Biopsy Techniques

A. B. C.

A1 S t t H d 10 C P ti 2000 12 C (D bl

x x

D. E.

A1 Sextant, Hodge, 1989

10 Core, Presti, 2000 12 Core, (Double Sextant)

13 Core, Eskew, 1997 11 Core, Babaian, 2001

x T2 biopsy

Why perform a saturation biopsy?Who is a Candidate?

• To diagnose cancer. (patients with abnormal or rising PSA or worrisome DRE who have already undergone one or more negative extended biopsies)extended biopsies)

• To determine extent of cancer in patients with a positive extended biopsy. (patients considering observation or focal cryotherapy)

• To assess local control in patients treated with initial radiation or cryotherapy.(patients with rising PSAs after radiation or cryotherapy)

Saturation Prostate Biopsies - Technique

• Position

•Dorsal lithotomy position (perineal)

•Lateral (transrectal)

• General anesthesiaGeneral anesthesia

• Grid (synchronize to TRUS image)

• Biopsy at grid coordinates

• Pull back according to length of prostate and length of biopsy needle. (18 gauge needle / 18mm biopsy core)

Cancer Detection on Repeat Biopsy

Sextant*† Saturation Biopsy‡§

1 prior biopsy 10-17% 36%

** Data adapted from Roehl et al (2002).†† Data adapted from Djavan et al (2001a).‡‡ Data adapted from Stewart et al (2001).§§ Data adapted from Fleshner and Klotz (2002).

2 prior biopsies 5-14% 31%

3+ prior biopsies 4-12% 14-36%

Patient preparationSimilar to that for prostate biopsy

Prophylactic antibioticCleansing enemaAnticoagulation medications are held

Preparation of the introducers

Three Bard 18 Gauge by 20 cm long brachytherapy seed

d i l strand implant needlesBone wax applied to the distal endGold marker loaded using stylet

Left lateral decubitus positionProstate imaged and measured3 mL of 1% lidocaine injected bilaterallyinjected bilaterally3 markers placed at the apex and left and right base

Planning CT

Portal Images

Anterior view

Cube-cut view

Axial view

with 3-D image of

prostate (red)

showing

Planning for permanent prostate implantEvaluation of pubic arch interference (PAI/PAO)

showing

pubic arch (yellow)

interference

Reduction of Pubic Arch InterferencePre - LHRH Monotherapy Post - LHRH Monotherapy

Planning for permanent prostate implant

3-D image of

prostate (red),

urethra (green)urethra

and prescribed dose

for Iodine-125

implant

(160 Gy = 16, 000

rads)

apexbase

Operating room setup

Wallner, K. Brachytherapy made complicated

urethral marker

rectal marker

pubic symphysis

Lateral scout view

Axial CT image

rectal marker

urethral marker

AP scout view

Transrectal ultrasound axial images

Prostate Brachytherapy using Transrectal Ultrasound

Needle

Prostate

Anterior view Lateral viewFoley catheter

Permanent prostate implant

155

Foley balloon

Iodine125 seeds

Pubic symphysis

Foley balloon

Foley catheter

Iodine125 seeds

Prostate Post-Implant Analysis

CT image

of prostate after

permanent implant

156

p p

of Pd-103 seeds

with

urethral marker

Urethra

Prostate Post-Implant Analysis

Seed Identificationand

Prostate contour

70 Gy isodose linePd-103

157

Isodose CoverageUrethra

3-D image of prostate,

150 Gy isodose surface

and I-125 seeds

Prostate150 Gy isodose line

and I-125 seeds

100%

90%

80%

70%

60%

The half-life of I-125 is 60.5 days,Pd-103 is 17 days.

After 10 half-lives (605 days for I-125, 170 days for Pd-103), less than 1/1000

Permanent Prostate ImplantPercent of Radioactivity Remaining after Time

50%

40%

30%

20%

10%

0

0

19

5.4

30

8.7

9

2.5

Days I-125

Days Pd-103

44

12.4

60

17

80

22.4

105

29.4

121

34

140

39.4

201

56.4

261

73.4

605

170

170 days for Pd 103), less than 1/1000(or less than 0.1%) of the original activity remains.

Primary Cryotherapy:Who is a Candidate?

• T1C – T3 disease, any grade

• Small T3’s in which ice will encompass tumor

• Alternate to radiation therapy

• Probably not as effective as surgery, especially in younger patients.

• Advantage in:

1. Obese patients

2. Cardiac disease

3. Inflammatory Bowel Disease

Cryotherapy – Tissue InjuryPutative mechanisms include:

1. Osmotic changes as a result of extracellular H2o transformation into ice.

2. Shearing forces exerted on cell membrane by extracellular ice crystals.

3. Intracellular freezing.

4. Tissue ischemia (destruction of blood vessels).

5. Immune responses.

The Cryoablation Procedure• 3rd generation probes with Argon/Helium

• Software with grid – improved probe

positioningpositioning

• Thermocouples

• Current procedure vastly different

from 1990’s

1. Imaging the prostate with Ultrasound

2. Treatment planning

3 Placement of cryoprobes3. Placement of cryoprobes

4. Placement of thermocouples

5. Placement of urethral warming catheter

6. Freezing

Individual patient anatomy can be entered into a computer-based treatment planning system.

This computer system helps optimize positioning of the cryotherapy probes and thermocouple positions.

Cryoprobes and thermocouples are placed transperineally through a

id b l grid or by manual guidance.

They are guided into place with ultrasound.

Thermocouple and ultrasound feedback is used to monitor progress. p g

Freezing is complete once critical temperatures are reached.

Probes Placed before Freeze Started in the

Sagittal Image of Posterior Ice Start

Ice Stopped at Denonvillier’s Fascia

Probes Placed before Freezing

Freeze Started in the Anterior

PSA – Recurrence Free Survival

Ref. N Crygen Median F/U

(months)

Nadir PSA

undetectable (%)

Low Medium High When Definition Neg Biopsie

s(%)

ADT (%)

Prepelica, 2005

65 A 35 83% 3 Yrs ASTRO 7/8(88)

68

Han, 2003

122 A 12 75% 1 Yr PSA >0.5 ng/ml

37

Efficacy of Primary Cryotherapy

Donnelly, 2002

76 N 50 75% 50 Mos

PSA >1.0 ng/ml

63/73 (86)

34

Bahn, 2002

590 A/N 68 92% 89% 89% 7 Yrs ASTRO 514/590 (87)

91

Long, 2001

975 A/N 24 76% 71% 61% 5 Yrs PSA >1.0(82)

33

De La Taille, 2000

35 A 8.3 22 (63) 70% 9 Mos PSA increase 0.2 above nadir

100

Koppie, 1999

176 N 31 88 (49) 56% 3 Yrs Nadir >0.5 or PSA increase of 0.2

103/167 (61)

28

Primary Cryotherapy – Complications (%)

N Erectile Dysfunction

Fistula Incontinence Sloughing / TURP

Han, 2003

Ellis, 2006

122

75

87

82

0

0

4.3

5.5

5.8

6.7,

Long, 2001

Bahn, 2001

975

590

93

95

0.5

0.1

7.5

4.3

13

5.5

Technical Modifications to Improve Potency

Focal Cryotherapy – partial (less than whole-

gland) treatment designed to spare one (or

both) NVB’s

– May treat entire ipsilateral side including

ipsilateral NVB.

– May limit treatment to region/location of

positive biopsy.

Technical Modifications to Improve Potency

Nerve – Warming Cryotherapy

– Use of helium probe in region of the neurovascular

bundle to actively warm during treatment.

Focal Cryotherapy – Early Results

Study N Follow-up

PSA Results Positive Post-

Treatment Biopsy (%)

Potency (%)

Onik, 2002

Bahn,

9

31

36

70

Stable

26/28 (93%)

0/6 (0%)

1/25 (4%)

7/9 (77%)

13/27 (48%)2006 (by Astro)

( )No treatment

11/27 (41%)With oral drugs

24/27 (89%)With or without drugs

Efficacy of cryosurgery in controlling recurrent prostate cancer after failure of

radiation therapy

Ref. No. of pts

Median FU (months)

Undetectable PSA

(<0.05 ng/ml)

PSA <0.5

ng/ml n (%)

Negative FU

biopsies n (%)

Patients receiving

ADT n (%)

Miller

Pisters

Chin

De la Taille

Han

33

150

106

43

18

16.8

17

43

21.9

20

NA

47 (31)

NA

NA

NA

3 (33)

63 (42)

114 (97)

26 (60)

13 (72)

26 (79)

116 (77)

91 (86)

NA

NA

16 (48)

40 (27)

71 (67)

43 (100)

0

Complications of Salvage Cryotherapy

Generation Author N Incontinence Obstruction Rectal Injury

Sloughing Fistula

3rd

3rd

Ghafar

Han

38

29

8%

7%

0

N/A

0

0

0

N/A

0

0

2nd

2nd

2nd

Pisters

Chin

Miller

150

118

33

73%

20%

9%

44%

8.5%

4%

1%

3.3%

0

N/A

5.1%

N/A

1%

3.3%

0

Management of Cryotherapy Complications

• Incontinence:- if mild, pads- if severe, artificial sphincter

• Obstruction – CIC(TUR can cause incontinence)(TUR can cause incontinence)

• Sloughing: - place catheter, or TUR

• Fistula: - colostomy

Cryotherapy - Conclusions• Minimally invasive.

• Fewer complications with 3rd generation equipment, ultra-

thin probes, and thermocouples.

• High potency rates with focal cryo (approx. 80-90%) –

longer follow-up needed.

• Acceptable alternative to radiation therapy.

• Most appropriate for older patients or those refusing

surgery.

Focal Cryotherapy – Early Results

Study N Follow-up

PSA Results Positive Post-

Treatment Biopsy (%)

Potency (%)

Onik, 2002

Bahn,

9

31

36

70

Stable

26/28 (93%)

0/6 (0%)

1/25 (4%)

7/9 (77%)

13/27 (48%)2006 (by Astro)

( )No treatment

11/27 (41%)With oral drugs

24/27 (89%)With or without drugs

Efficacy of cryosurgery in controlling recurrent prostate cancer after failure of

radiation therapy

Ref. No. of pts

Median FU (months)

Undetectable PSA

(<0.05 ng/ml)

PSA <0.5

ng/ml n (%)

Negative FU

biopsies n (%)

Patients receiving

ADT n (%)

Miller

Pisters

Chin

De la Taille

Han

33

150

106

43

18

16.8

17

43

21.9

20

NA

47 (31)

NA

NA

NA

3 (33)

63 (42)

114 (97)

26 (60)

13 (72)

26 (79)

116 (77)

91 (86)

NA

NA

16 (48)

40 (27)

71 (67)

43 (100)

0

Complications of Salvage Cryotherapy

Generation

Author N Incontinence

Obstruction Rectal Injury

Sloughing

Fistula

3rd

3rd

Ghafar

Han

38

29

8%

7%

0

N/A

0

0

0

N/A

0

0

2nd

2nd

2nd

Pisters

Chin

Miller

150

118

33

73%

20%

9%

44%

8.5%

4%

1%

3.3%

0

N/A

5.1%

N/A

1%

3.3%

0

Management of Cryotherapy Complications

• Incontinence:- if mild, pads- if severe, artificial sphincter

• Obstruction – CIC(TUR can cause incontinence)(TUR can cause incontinence)

• Sloughing: - place catheter, or TUR

• Fistula: - colostomy

Cryotherapy - Conclusions• Minimally invasive.

• Fewer complications with 3rd generation equipment, ultra-

thin probes, and thermocouples.

• High potency rates with focal cryo (approx. 80-90%) –

longer follow-up needed.

• Acceptable alternative to radiation therapy.

• Most appropriate for older patients or those refusing

surgery.

Transrectal Prostate Ultrasound and Prostate Biopsy Report

Name________________________________ MR# _____________ Date_________ DIAGNOSIS: □ Elevated PSA □ Abnormal Exam Current PSA__________ PROCEDURES: □ Echography of Prostate □ US Guidance for needle biopsy □ Transrectal needle biopsy of prostate SURGEON: ___________________________ Signature: __________________________ TRANSRECTAL ULTRASOUND: □ PSA density: ________ ng/cc □ Prostate measurements: Height_____ mm; Width ______ mm; Length ______ mm □ Prostate volume: ________ cc □ No hypoechogenic areas suggestive of cancer are seen. □ Hypoechogenic areas exist which could represent areas of malignancy. These are seen in the following locations: ___________________________________ □ Hyperdense echos are seen suggestive of calculi in the capsule. □ Seminal vesicles: □ normal □ other ______________________________________ □ Prostate median lobe: □ absent □ present, size: ________________________________ □ Bladder exam: □ normal □ abnormal _________________________________________ □ Documentation images were taken. OPERATIVE DESCRIPTION: Informed consent was obtained and signed. The patient was placed in the left lateral decubitus position. The 7.0 mHz biplanar transrectal ultrasound probe was placed in the rectum. Imaging in transverse and longitudinal views was done with the findings as indicated. (Example only – each urologist should formulate his/her own operative description.) ULTRASONIC GUIDED PROSTATE BIOPSY: □ Prostate anesthetic block was performed using 1% Xylocaine. □ Biopsies of abnormal appearing areas were performed. □ Biopsies were taken from the base, mid-gland and apex bilaterally as indicated. □ Total number of biopsies taken: __________. □ Documentation images were taken. OPERATIVE DESCRIPTION: Multiple biopsies of the prostate via needle were obtained using ultrasonic guidance into the rectum. Post operative instructions were given to the patient in detail per post op instruction sheet. Patient will be contacted with the biopsy result when available. (Example only – each urologist should formulate his/her own operative description.)

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