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2. "SELECTION OF SALVAGE CRYOTHERAPY PATIENTS"

 

Author: Katz AE, Ghafar MA

Institution: Department of Urology, College of Physicians and

Surgeons of Columbia University in New York,New York

Date/Publication: 2002, Reviews in Urology Vol. 4 (Supp 2)

Indication: Salvage

Key Words: Failed Radiation, Patient Selection

Summary:

Approximately 1/3 of prostate cancer patients choose radiation

therapy for treatment, and between 20% and 66% of these

patients fail in radiation treatment. Salvage cryosurgery is the

preferential option for those patients requiring a secondary treatment

after their first failure. Before performing salvage

cryosurgery, patients might need hormonal therapy in order to

reduce the size of the prostate gland and allow more working

space for the cryosurgeon. Certain refinements can make salvage

cryosurgeon especially effective such as using an argon-based

system with thermocoupling, using an external sphincter temperature

probe, or continuing urethral warming in the recovery

room for 2 additional hours.

3. "SALVAGE CRYOSURGERY - HOW I DO IT"

Author: Donnelly BJ, Saliken JC

Institution: Tom Baker Cancer Center and Calgary Prostate

Institute in Calgary,Alberta, Canada

Date/Publication: 2002, Reviews in Urology Vol. 4 (Supp 2)

Indication: Salvage

Key Words: Salvage Cryo technique, patient selection

Summary:

Appropriate patient selection is imperative for successful salvage

cryosurgery. For it to be successful, the cancer must be confined to

the prostate and its immediate area. Of those patients whose cancer

recurs after radiation therapy, only 24.3% have isolated local

recurrence without distant disease. Identifying this population can

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Salvage Cryoablation

1. "SALVAGE CRYOSURGERY FOR RECURRENT PROSTATE CANCER

AFTER RADIATION THERAPY: A SEVEN- YEAR FOLLOW-UP"

Author: Bahn DK, Lee F, Silverman P, Bahn E, Badalament R,

Kumar A, Greski J, Rewcastle JC

Institution: Prostate Institute of America, Community Memorial

Hospital in Ventura, California

Date/Publication: September 2003, Clinical Prostate Cancer

Vol. 2 (2)

Indication: Salvage

Patient Selection: Patients must have previous radiation therapy

treatment at least 24 months before treatment and biopsyproven

recurrent prostate cancer without evidence of distant

metastasis

Number of Patients: 59

Length of Follow-up: 7 years

Efficacy: 59%

Measurement of Efficacy: PSA level less than or equal to 0.5

ng/mL

Morbidity: 4.3% incontinence and 3.4% rectal fistula formation

Key Words: Biochemical relapse, radiation failure, salvage therapy

Summary:

Radiation therapy remains a prominent treatment of prostate cancer,

yet it has multiple drawbacks.For example,the procedure cannot be

repeated and some tumors are resistant to radiation. Salvage radical

prostatectomy has been an option for salvage treatment but it is a

complex and risky procedure associated with high comorbidity and

extended hospitalization.Hormonal treatment may reduce tumor size

and cause slower growth,but it is not curative. Since the mid-1990s

cryosurgery has had success in treating radiation-resistant prostate

cancer.Through a 7-year retrospective analysis, the results of this study

demonstrate that salvage cryosurgery is a promising form of treatment.

It shows a success rate comparable with salvage radical prostatectomy

and hormonal therapy. Results are especially favorable when

the PSA is less than 10 and tumor stage is T1-T2.The data shows minimal

morbidity rates and no known latent complications. In addition,

the procedure is minimally invasive, requiring a short hospital stay.

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S A L V A G E C R Y O A B L A T I O N S A L V A G E C R Y O A B L A T I O N

reasonable expectation that the local tumor burden could be

encompassed in the freezing process

Number of Patients: 131

Length of Follow-up: 5 years

Efficacy: 90% T1-T2, 69% T3-T4

Measurement of Efficacy: 5 year disease-free rates

Key Words: Patient selection, salvage cryo

Summary:

This report is the first long-term study on patients undergoing a

salvage therapy for recurrent prostate cancer after radiation therapy.

The purpose of the study is to identify the pretreatment factors

that have an impact on the success of salvage cryosurgery.

The results indicate that patient selection is very important for

cryosurgery since not all locally recurrent prostate cancers have

the same natural history.The results indicate that cryosurgery is

an optimal treatment for patients who have locally recurrent

androgen-dependent disease, a PSA level of less than 10 ng/mL,

Gleason scores of less than 9, and pre-XRT clinical stages of T1 to

T2. On the other hand, salvage cryotherapy is more likely to fail

in patients who have locally recurrent androgen-independent

PCa, a PSA level of greater than 10 ng/mL, a Gleason score of 9

and 10, or a pre-XRT clinical stage greater than T2.What is not

known is whether the unfavorable patients would receive a significantly

greater benefit from another therapy.

5. "SALVAGE CRYOTHERAPY USING AN ARGON BASED SYSTEM FOR

LOCALLY RECURRENT PROSTATE CANCER AFTER RADIATION

THERAPY: THE COLUMBIA EXPERIENCE"

Author: Ghafar MA, Johnson CW, De La Taille A, Benson MC,

Bagiella E, Fatal M, Olsson CA, Katz AE

Institution: Department of Urology, College of Physicians and

Surgeons of Columbia University in New York,New York

Date/Publication: October 2001, Journal of Urology Vol. 166 (4)

Indication: Salvage

Patient Selection: Must have biochemically and biopsy proven

disease recurrence and negative bone scan 15

be difficult.The minimal requirements of identification include a

positive prostatic biopsy and negative bone scan. Other selection

criteria include PSA level, Gleason score, and absence of T3 and

T4 disease.The technique used by Donnelly is a modification of

that originally described by Onik. Cases are treated by the combined

efforts of an urologist and radiologist. Patient positioning

is important to allow good access to the perineum.A flexible

cystoscope is used to visualize the prostate and bladder and to

guide the pigtail catheter.A urethral warming catheter is placed

in the bladder over the guidewire.A biplane TRUS probe is

inserted into the rectum to visualize and measure the prostate.

Usually six cryoprobes are used but more or fewer can be used

if the prostate is exceedingly large or small, or unusually shaped.

Lateral placement of the probes is important because the temperature

between probes is much lower than the temperature at

the edge of the iceball.Another critical factor is the thermocouples

that are placed where specific temperatures need to be

achieved.The temperature of the posterolateral probes (3 & 4)

impact how rapidly the iceballs form on the other probes.The

operator should continue the freeze longer than he or she thinks

is necessary in order to achieve a truly adequate ablation.The

second freeze is initiated after a complete thaw and should

progress faster than the first.

4. "SALVAGE CRYOTHERAPY FOR RECURRENT PROSTATE CANCER

AFTER RADIOTHERAPY: VARIABLES AFFECTING PATIENT OUTCOME"

Author: Izwawa JI, Madesen LT, Scott SM,Tran JP,McGuire EJ,

Von Eschenbach AC, Pisters LL

Institution: Department of Urology, University of Texas M.D.

Anderson Cancer Center in Houston,Texas

Date/Publication: June 2002, Journal of Clinical Oncology Vol.

20 (11)

Indication: Salvage

Patient Selection: no exclusion criteria related to local extent

of disease, PSA level, or Gleason score, provided there was a

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S A L V A G E C R Y O A B L A T I O N S A L V A G E C R Y O A B L A T I O N

Indication: Salvage

Patient Selection: Patients must have increasing PSA levels on 3

consecutive determinations at least 2 years after administration

of radical radiation therapy

Number of Patients: 118

Length of Follow-up: 18.6 months

Efficacy: 87%

Measure of Efficacy: Patients free of histological failure

Morbidity: 3.3% rectourethral fistulas, 6.7% severe incontinence

Key Words: salvage, radiation failure, patient selection, complication

predictions

Summary:

Salvage cryotherapy has been reported as technically more challenging

than primary cryotherapy and the complications more

significant. However, through this study predictors of treatment

failure and complications can be identified in order to find a

patient selection criteria that will produce positive salvage

cryotherapy results. Data from this study identifies bulky stage

T3B and T4A disease as a predictive factor for urinary fistula formation

and prior transurethral surgery as a predictive factor for

incontinence. Results from cases without these factors demonstrate

postoperative complications that are acceptable.The quality

of life assessment indicates favorable patient satisfaction and

acceptance of cryoablation. Factors that would predict an unfavorable

outcome include PSA level greater than 10 ng/mL, a high

Gleason score, stage T3/T4 disease, and increasing PSA levels

despite hormone therapy. However, this patient group probably

has systemic disease, which is not curative with any form of

local therapy.

7. "LOCAL TUMOR CONTROL WITH SALVAGE CRYOTHERAPY FOR

LOCALLY RECURRENT PROSTATE CANCER AFTER EXTERNAL BEAM

RADIOTHERAPY"

Author: Izawa JI, Perrotte P, Greene GF, Scott S, Levy L, McGuire

E, Madsen L,Von Eschenbach AC, Pisters LL

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Number of Patients: 38

Length of Follow-up: 20.7 months

Efficacy: 86% at 1-year, 74% at 2 years

Measurement of Efficacy: biochemical recurrence-free survival

calculated from Kaplan-Meier curves

Morbidity: 39.5% rectal pain, 2.6% urinary tract infection, 7.9%

incontinence, 7.9% hematuria, 10.5% scrotal edema, 0% rectourethral

fistula, urethral sloughing and urinary retention

Key Words: argon based system, efficacy, safety, salvage

Summary:

There are limited options for recurrent cancer patients.

Additional radiation is not acceptable since tumors are clearly

radio resistant. Cytotoxic chemotherapy and hormonal therapy

are not curative. Salvage radical prostatectomy is a technically

challenging procedure that is associated with high comorbidity

and long hospitalization.The modernization of cryotherapy,

including the new argon based CRYOCare machine, make

cryotherapy a suitable option for salvage therapy since it has little

complication and successful disease-free survival rates.With

the introduction of ultrasound monitoring, thermocouples, and

the urethral warming system, morbidities associated with salvage

cryotherapy have remained low.The results of this study indicate

that cryosurgery is an effective clinical therapy for recurrent

localized prostate cancer. It is less invasive, causes little trauma,

and has fewer side effects than salvage radical prostatectomy.

6. "RESULTS OF SALVAGE CRYOABLATION OF THE PROSTATE AFTER

RADIATION: IDENTIFYING PREDICTORS OF TREATMENT FAILURE

AND COMPLICATIONS"

Author: Chin JL, Pautler SE, Mouraviev V,Touma N, Moore K,

Downey DB

Institution: Division of Urology and Department of Diagnostic

Radiology, London Health Sciences Center, University of Western

Ontario in London, Ontario, Canada

Date/Publication: June 2001, Journal of Urology Vol. 165 (6 Pt1)

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S A L V A G E C R Y O A B L A T I O N S A L V A G E C R Y O A B L A T I O N

8. "CRYOSURGERY: IS IT AN EFFECTIVE OPTION FOR PATIENTS FAILING

RADIATION?"

Author: de la Taille A, Katz AE

Institution: Department of Urology, Columbia University

College of Physicians and Surgeons in New York,New York

Date/Publication: September 2000, Current Opinion in Urology

Vol. 10 (5)

Indication: Salvage

Key Words: salvage, new technology, low morbidity, cost

Summary:

De la Taille and Katz give an overview of salvage cryosurgery.

Primary treatment of prostate cancer using radical prostatectomy

and radiation therapy have a recurrent and residual disease rate

ranging from 25% to 93%.Therefore, many patients turn toward

the four options of salvage surgery: salvage prostatectomy, salvage

brachytherapy, hormonal therapy, and salvage cryotherapy.

Continuing advances and refinements in cryotechnology have

made it a safe and efficacious treatment for prostate cancer. For

example, the addition of temperature probes and ultrasound

monitoring have helped lower morbidities associated with

cryotherapy compared to what was previously reported.

Cryotherapy produces cancer cell death though three key factors:

direct mechanical shock, osmotic shock, and cellular hypoxia.

Since cost becomes a critical factor in healthcare, it is important

to note that cryotherapy is half of the usual cost for either

radical prostatectomy or radiation therapy.

9. "SALVAGE CRYOTHERAPY FOR RECURRENT PROSTATE CANCER

AFTER RADIATION THERAPY: THE COLUMBIA EXPERIENCE"

Author: de la Taille A, Hayek O, Benson MC, Bagiella E, Olsson

CA, Fatal M, Katz AE

Institution: Departments of Urology and Biostatistics, Columbia

University College of Physicians and Surgeons in New York,New

York

Date/Publication: January 2000, Urology Vol. 55 (1)

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Institution: Department of Urology and Biomathematics,

University of Texas M.D.Anderson Center in Houston,Texas

Date/Publication: March 2001, Journal of Urology Vol. 165 (3)

Indication: Salvage

Patient Selection: no study exclusion criteria for local disease

extent, PSA, or Gleason score if there was a reasonable expectation

that the local tumor burden would be encompassed in the

freezing process

Number of Patients: 145

Length of Follow-up: 6 months

Efficacy: 77%

Measurement of Efficacy: negative biopsy after salvage

cryosurgery

Key Words: Radiation failure, salvage cryosurgery efficacy,

patient selection, technique

Summary:

This study focuses on determining which patients are the most

appropriate candidates and the optimal cryotherapy procedure.

The results demonstrate that a higher initial clinical stage and

PSA level greater than 10.3 ng/mL correlate with a positive

biopsy after salvage cryosurgery.Therefore, patients with clinical

stage T1-TN0M0 disease and PSA level less than 10.3 ng/mL are

likely to benefit from salvage cryosurgery. In addition to this,

patients with a life expectancy of 10 years or more are more

likely to benefit from the procedure and justify the potential

morbidity.The cryosurgery technique that optimizes local

control while minimizing morbidity includes a minimum of 5

probes, 2 freeze-thaw cycles and a urethral warming catheter.

Multivariate analysis shows that PSA level and the number of

cryotherapy probes are the strongest predictors of a positive

biopsy.

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S A L V A G E C R Y O A B L A T I O N S A L V A G E C R Y O A B L A T I O N

Primary Cryoablation

1. "IN TREATING LOCALIZED PROSTATE CANCER THE EFFICACY OF

CRYOABLATION IS INDEPENDENT OF DNA PLOIDY TYPE"

Author: Bahn DK, Silverman P, Lee F Sr, Badalament R, Bahn ED,

Rewcastle JC

Institution: University Laboratories, Detroit Medical Center

Date/Publication: June 2004,Technology in Cancer Research

and Treatment Vol.3 (3)

Indication: Primary

Patient Selection: Patients with prostate cancer and whose

DNA ploidy was known prior to treatment

Number of Patients: 447

Length of Follow-up: 5 years

Efficacy: 78% (diploid), 75% (tetraploid), 79% (aneuploid)

Measurement of Efficacy: Used Kaplan-Meier analysis with a

PSA cutoff of 1.0 ng/mL

Key Words: DNA Ploidy and Cryotherapy, broad range of use

Summary:

There is substantial evidence indicating that differences in DNA

ploidy are highly predictive of differential treatment responses of

patients to radical surgery and radiation therapy. It has been

found that patients with aneuploid tumors suffer substantially

worse than patients with diploid tumors in terms of progression

and spread of disease and biochemical disease free status

(bDFS). However, the results of this experiment demonstrate that

the efficacy of cryoablation is independent of DNA ploidy type.

Since cryoablation damages cells regardless of their individual

characteristics, all ploidy types of tumors are killed.Therefore,

cryoablation is a preferential treatment to radiation and radical

surgery since it treats non-diploid tumors as well as it treats

diploid tumors.

21

Indication: Salvage

Patient Selection: Patients must have completed external beam

radiation therapy at least 18 months before evaluation, a rising

serum PSA value, biopsy-proven recurrent prostate cancer without

seminal vesicle invasion, negative bone scans, and no evidence

of disease in the lymph nodes

Number of Patients: 43

Length of Follow-up: 21.9 months

Efficacy: 79% at 6 months and 66% at 12 months

Measurement of Efficacy: biochemical recurrence-free survival

(bRFS) defined as a PSA value less than 0.1 ng/mL

Morbidity: 9% incontinence, 5% obstruction, 5% urethral stricture,

26% rectal pain, 9% urinary infection, 12% scrotal edema,

and 5% hematuria

Key Words: salvage, low morbidity, efficacy

Summary:

Cryosurgical technology has been applied in the past to a wide

variety of neoplasms.The cold environment created has proven

to destroy both cancerous and normal cells.Advances have been

made in cryoablation to make it a safe and efficacious treatment.

For example, the procedure is now performed percutaneously

and uses real-time transrectal ultrasound guidance and FDA

approved urethral-warming devices.When consulting a patient

for salvage therapy the first step should consist of a prostate and

seminal vesicle ultrasound-guided biopsy. If the biopsy reveals

seminal vesicle involvement, cryosurgery is not recommended.

Androgen deprivation is usually used before salvage cryosurgery

to decrease the prostate and facilitate a faster freeze with less

gas required.The results from this study support the current safety

and efficacy profile that cryotherapy is a viable option in the

treatment of patients who have biopsy-proven local failure after

radiation therapy.

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S A L V A G E C R Y O A B L A T I O N P R I M A R Y C R Y O A B L A T I O N

3. "TARGETED CRYOABLATION OF THE PROSTATE: 7-YEAR OUTCOMES

IN THE PRIMARY TREATMENT OF PROSTATE CANCER"

Author: Bahn DK, Lee F, Badalament R,Kumar A, Greski J,

Chernick M

Institution: Crittenton Hospital in Rochester, Michigan

Date/Publication: August 2002, Urology Vol. 60 (Supp 2A)

Indication: Primary

Patient Selection: patients eligible if they exhibited localized or

locally advanced prostate cancer (TNM stage T1 or T3)

Number of Patients: 590

Length of Follow-up: 7 years

Efficacy: 92% (low), 89% (medium), 89% (high)

Measurement of Efficacy: ASTRO definition of biochemical

failure based on 3 successive increases of PSA level

Morbidity: 4.3% incontinence, 94.9% impotence (5.1% recovered

potency), 5.5% transurethral resection of the prostate

(TURP), <0.1% Fistula

Measurement of Morbidity: Measurements based on rates

immediately after surgery and adjusted to include 7-year followup

on patients

Key Words/Concepts: high efficacy, broad range of use, superiority

to RF

Summary:

The procedure and results of this experiment show the evolution

of cryoablation as the modern transrectal ultrasound-guided

percutaneous method differentiates itself from the early 1960's

use of cryotherapy.With the results of this 7-year data, cryotherapy

can be compared with 7 year follow-up data on radiation

therapy.Through this comparison it can be seen that cryotherapy's

high efficacy rate make it comparable if not superior to radiation

and other traditional treatments.While cryotherapy has

been accepted as advantageous for treatment of older patients or

patients having too much comorbidity, the data from this report

indicates a broader role for cryoablation.The high efficacy seen

23

2. "THE CURRENT AND POTENTIAL ROLE OF CRYOABLATION AS

PRIMARY THERAPY FOR LOCALIZED PROSTATE CANCER"

Author: Katz AE, Rewcastle JC

Institution: Department of Urology, College of Physicians and

Surgeons of Columbia University, Columbia-Presbyterian Medical

Center

Date/Publication: May 2003, Current Oncology Reports Vol. 5 (3)

Indication: Primary (and smaller discussion on Focal)

Length of follow-up: 5 year follow-up on various prostate treatments

conducted over the past 10 years (1992-2002)

Key Words: High efficacy, low morbidity, comparison with

other treatments, focal cryo

Summary:

Katz and Rewcastle compiled 5 year follow-up reports on various

treatments of prostate cancer including cryoablation, radical

prostatectomy, brachytherapy, 3-D conformal radiation, and external-

beam radiation performed over the past ten years.Through

this comparison they were able to provide sufficient data to

show that cryotherapy is comparable if not superior in treating

prostate cancer.The recent advances in cryo technology have

made targeted cryoablation much more effective than its use

during its reintroduction in the early 1990's.A comparison of

recent publications demonstrates that cryotherapy's efficacy is

equivalent to other treatments in treating low-risk disease and

possibly superior for moderate- to high-risk prostate cancer. In

addition, morbidity in cryotherapy is mild in comparison with

other procedures with the exception of impotence. However,

studies demonstrate that sexual function returns to a large number

of impotent patients (cf. Robinson studies below).While

morbidity declines for cryotherapy over time, results of other

treatments reveal the emergence of late-onset morbidity.

Therefore, cryoablation proves to be an effective treatment preserving

the quality of life for patients.The article also discusses

the potential role of focal cryoablation as an ideal treatment for

targeting less aggressive forms of prostate cancer.

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P R I M A R Y C R Y O A B L A T I O N P R I M A R Y C R Y O A B L A T I O N

Summary:

Ellis demonstrates that cryosurgery as a primary treatment for

prostate cancer is an effective and safe procedure that can be

performed in a community hospital setting with outcomes comparable

to outcomes achieved in academic hospital settings.The

efficacy and morbidity results of those treated in the community

hospital compare favorably with the published results of procedures

performed in academic hospital settings.The procedures

were done by a single urologist suggesting that cryosurgery is

possible for any urologist to perform provided he or she has: 1)

imaging, interventional, and surgical skills; 2) competence with a

cystoscope; 3) an understanding of ice ball thermodynamics and

cryobiology; and 4) cryosurgery-specific experience.

5. "QUALITY OF LIFE AND SEXUALITY OF MEN WITH PROSTATE CANCER

3 YEARS AFTER CRYOSURGERY"

Author: Robinson JW, Donnelly BJ, Saliken JC,Weber BA, Ernst S,

Rewcastle JC

Institution: University of Calgary in Calgary,Alberta, Canada

Date/Publication: August 2002, Urology Vol. 60 (Supp 2A)

Indication: Primary

Patient Selection: Biopsy-proven adenocarcinoma of the

prostate, PSA level less than or equal to 30 ng/mL, a stage of T1

to T3 NO MO by clinical evaluation, bone scan, chest x-ray and

TRUS guided biopsies

Number of Patients: 76 men

Length of Follow-up: Quality of life checkups: 6 months, 1

year, and 3 years; medical and biochemical assessment ongoing

Efficacy: 5 year follow-up: 69% PSA < 0.3

Measurement of Efficacy: PSA level

Key Words: quality of life, sexual function

Summary:

This study focuses on the degree to which men who have undergone

cryosurgery are able to recapture the quality of life (QOL)

they enjoyed before treatment.Two questionnaires were adminis-

25

in local and locally advanced cases shows that cryoablation can

be applied as a primary treatment for various cases.A comparison

with radiation also demonstrates that cryoablation is a quick

procedure (one night stay), less expensive than competing procedures,

and comparable, if not lower, in morbidity rates.

Therefore the results from this experiment should induce a

greater acceptance of cryoablation as a viable primary treatment

option for local to locally advanced cancer.

4. "CRYOSURGERY AS PRIMARY TREATMENT FOR LOCALIZED

PROSTATE CANCER: A COMMUNITY HOSPITAL EXPERIENCE"

Author: Ellis DS

Institution: Arlington Memorial Hospital in Arlington,Texas and

Baylor Medical Center in Coppell,Texas

Date/Publication: August 2002, Urology Vol. 60 (Supp 2A)

Indication: Primary (small % of salvage patients)

Patient Selection: Biopsy-proven adenocarcinoma of the

prostate, PSA testing, full routine clinical staging, and Gleason

score evaluations

Number of Patients: 93 (75 primary, 18 salvage)

Length of Follow-up: 1 year

Efficacy: 84%

Measurement of Efficacy: PSA levels of less than or equal to

0.4 ng/mL

Morbidity: 1.4% severe incontinence, 4% mild incontinence,

1.3% transurethral resection, 6.7% urethral sloughing, 82.4%

impotence

Measurement of Morbidity: Measured up to a year after surgery.

Severe incontinence = requiring > 2 pads per day, mild

incontinence = requiring < 2 pads per day

Key Words: community hospital setting, safety and efficacy, salvage,

training of physician

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P R I M A R Y C R Y O A B L A T I O N P R I M A R Y C R Y O A B L A T I O N

Thermocouple junctions placed at various radial distances from

the probe allow cell ablation and temperature to be recorded.

The results indicate that double-freeze can achieve cryoablation

of a larger volume of target tissue than a single-freeze procedure.

Definitive cryoablation is -60oC for single-freeze and -40oC for

double-freeze.These results provide a basis for more optimal use

of temperature monitoring during cryosurgery.This will allow for

eradication of prostate cells with minimum potential for complications.

7. "A PROSPECTIVE TRIAL OF CRYOSURGICAL ABLATION OF THE

PROSTATE: FIVE-YEAR RESULTS"

Author: Donnelly BJ, Saliken JC, Ernst DS,Ali-Ridha N, Brasher

PMA, Robinson JW, Rewcastle JC

Institution: Tom Baker Center and University of Calgary

Date/Publication: October 2002, Urology Vol. 60 (4)

Indication: Primary (small % of salvage cases)

Patient Selection: histologically proven adenocarcinoma, PSA

levels less than 30 ng/mL, and negative bone scans

Number of Patients: 76

Length of Follow-Up: 5 years

Efficacy: 98.6 % cancer-specific survival rate

Measurement of Efficacy: Negative biopsy

Morbidity: 3.9% sloughing, 1.3% incontinence, 1.3% testicular

abscess, all experience impotency immediately after surgery but

47% regained sexual function 3 years after surgery

Measurement of Morbidity: Follow-up biopsy, quality of life

questionnaire, and sexual questionnaire (FACT-P)

Key Words: efficacy, safety

Summary:

In the past, complications such as urethroperineal and urethrorectal

fistulas have caused cryotherapy to be questioned.

However after the development of TRUS probes, real-time imaging,

well-insulated cryoprobes, and a urethral warming device,

27

tered, the Functional Assessment of Cancer Treatment- Prostate

(FACT-P) and the Sexuality Follow-Up Questionnaire (SFQ), to

quantify the changes in QOL.While there were decreases in

FACT-P scores 6 weeks after surgery, by 12 months there were

no significant differences with feelings prior to surgery with the

exception of sexuality.However, sexuality scores continually rose

after two years due to a return of sexual function and the usefulness

of sexual aids. Comparing scores at 1 year to 3 years

demonstrates 47% improvement in sexual functioning.There are

no other significant changes between 1 year to 3 years suggesting

that life remained stable after the first year of treatment and

that there are no delayed complications of prostate cryotherapy.

These results can be tentatively compared to publications of

other treatments to demonstrate that QOL scores 3 years after

treatment are at least as high from cryosurgery as from radical

prostatectomy, external-beam radiotherapy, or brachytherapy.

6. "IN VIVO INTERSTITIAL TEMPERATURE MAPPING OF THE HUMAN

PROSTATE DURING CRYOSURGERY WITH CORRELATION TO

HISTOPATHOLOGIC OUTCOMES"

Author: Larson TR, Robertson DW, Corica A, Bostwick DG

Institution: Department of Urology, Mayo Clinic, Scottsdale,

Arizona

Date/Publication: April 2000, Urology Vol. 55 (4)

Indication: Primary

Patient Selection: Men with prostate cancer who had been previously

scheduled to undergo radical retropubic prostatectomy

as their primary treatment

Number of Patients: 6

Key Words: critical temperatures, double freeze vs. single

freeze, temperature mapping

Summary:

The purpose of this study is to determine the critical temperatures

below which human prostatic tissue can be cryoablated,

and to compare the efficacy of single-freeze vs. double-freeze.

26

P R I M A R Y C R Y O A B L A T I O N P R I M A R Y C R Y O A B L A T I O N

rary reports of patient outcomes after radiotherapy. Because of

the large sample, the cryosurgery technique was performed with

some variation with only a small number treated with the most

advanced use of all modern features (two freeze cycles,

approved urethral warming, thermocouple monitoring, and 6-8

cryoprobes). However despite the variations the experimental

outcome was very comparable to outcomes after radiotherapy as

the positive biopsy rate of cryotherapy matched results of radiotherapy.

Significant differences appeared in rates of erectile dysfunction

and rectal injury between the two treatments, with

lower rates of rectal problems after cryotherapy but higher rates

of potency after radiotherapy. Overall the data in this report indicates

that cryotherapy can be performed with low morbidity

and can produce results comparable to radiotherapy.

9. "QUALITY-OF-LIFE OUTCOMES FOR MEN TREATED WITH

CRYOSURGERY FOR LOCALIZED PROSTATE CARCINOMA"

Authors: Robinson JW, Saliken JC, Donnelly BJ, Barnes P, Guyn L

Institution: University of Calgary in Calgary,Alberta, Canada

Date/Publication: November 1999, Cancer Vol. 86 (9)

Indication: Primary

Patient Selection: Biopsy-proven adenocarcinoma of the

prostate, PSA level less than or equal to 30 ng/mL, a stage of T1

to T3 NO MO by clinical evaluation, bone scan, chest x-ray and

TRUS guided biopsies

Number of Patients: 69

Length of Follow-up: 1 year

Efficacy: 68% PSA < 0.3, 32% PSA >0.3

Measure of Efficacy: PSA level

Key Words: quality-of-life (QOL), sexual function, cryosurgery,

radiotherapy

Summary:

Since early use of cryotherapy was abandoned due to a high incidence

of complications, this study aims to determine the quality

of life of men after treatment of prostate cancer with modern-

29

cryosurgery has improved in efficacy and safety.Through the

results of this study, Donnelly, et al have demonstrated that properly

delivered cryosurgical ablation has a high efficacy providing

that the cancer is confined to the prostate and immediate vicinity.

The procedural complications are similar to those reported

elsewhere and compare favorably to other treatments.

Impotence has the highest morbidity but the nerves are frozen

and not cut and therefore have the potential to recover. Other

treatments show a potency rate of 25% after 18 months. Since

47% of the cryosurgery patients resumed sexual function,

cryosurgery potency rates compare favorably with other treatments.

As do other treatments, cryosurgery requires long training

and experience.

8. "FIVE YEAR RETROSPECTIVE, MULTI-INSTITUTIONAL POOLED

ANALYSIS OF CANCER-RELATED OUTCOMES AFTER CRYOSURGICAL

ABLATION OF THE PROSTATE"

Author: Long JP, Bahn D, Lee F, Shinohara K, Chinn DO, Macaluso

JN Jr

Institution: New England Medical Center, University of

California at San Francisco, Urologic Institute of New Orleans,

Crittenton Hospital, and Alhambra Hospital

Date/Publication: March 2001, Urology Vol. 57 (3)

Indication: Primary

Patient Selection: Clinical stages T1-T4, any PSA level, and any

Gleason grade

Number of Patients: 975

Length of Follow-Up: 5 years

Efficacy: 82%

Measurement of Efficacy: biopsy after procedure

Key Words: comparison between radiotherapy and cryosurgery,

efficacy, safety

Summary:

Study includes a retrospective analysis of a large database of

patients from five institutions and comparison with contempo-

28

P R I M A R Y C R Y O A B L A T I O N P R I M A R Y C R Y O A B L A T I O N

complications, the results disproved this concern as no complications

appeared using 6-8 cryoprobes.Therefore, this study

indicates that using 6-8 cryoprobes has an advantage over the

use of 5 cryoprobes.

11. "CRYOSURGICAL ABLATION OF THE PROSTATE: HIGH RISK

PATIENT OUTCOMES"

Author: Prepelica KL, Okeke Z, Murphy A, Katz AE

Institution: Columbia-Presbyterian Medical Center in New York,

New York

Date/Publication: April 2005, Cancer Vol. 103 (8)

Indication: Primary

Patient Selection: Patients with prehormone therapy high-risk

features (high risk defined as either a PSA level greater than or

equal to 10 ng/mL, Gleason sum score greater than or equal to 8,

or both of these features)

Number of Patients: 65

Length of Follow-up: 35 months

Efficacy: 83.3%

Measurement of Efficacy: The American Society for

Therapeutic Radiology and Oncology (ASTRO) definition of

biochemical failure (3 consecutive increases in PSA level)

Morbidity: 3.1% Rectal pain, 3.1% urinary retention, 3.1% incontinence,

1.5% voiding complications, no perineal discomfort,

rectourinary fistula, or disease progression

Measurement of Morbidity: Measured immediately after

surgery and up to 77 months

Key Words: High Risk, efficacy

Summary:

This study focuses on men with high-risk features for prostate

carcinoma who were unwilling to undergo radical surgery or

radiation therapy. Using the modern system of cryotherapy

which includes TRUS and urethral warmers, the high risk

patients received efficacious results.The results from this study

31

ized cryotherapy procedures. Patients completed the Functional

Assessment of Cancer Treatment-Prostate (FACT-P) before the

procedure, 6 weeks, and 3, 6, and 12 months after the procedure.

Despite a drop in FACT-P scores from pretreatment to 6 weeks,

by 12 months there were no significant differences compared

with pretreatment scores, with the exception of sexual function.

There was a sharp decline in sexual function at 6 weeks and

then only a small increase over the year.However, twelve months

may not be sufficient time to observe the full degree to which

erectile functioning will return subsequent to cryosurgery.The

overall pattern of results suggests that cryosurgery has a minimal

impact on QOL since most aspects of a patient's life prior to surgery

will return after 1 year of cryotherapy.

10. "CRYOSURGERY FOR PROSTATE CANCER: IMPROVED GLANDULAR

ABLATION BY USE OF 6 TO 8 CRYOPROBES"

Author: Lee F, Bahn DK, Badalament RA,Kumar AB, Klionsky D,

Onik GM, Chinn DO,Greene C

Institution: Crittenton Hospital in Rochester, Michigan

Date/Publication: July 1999, Urology Vol. 54 (1)

Indication: Primary

Patient Selection: Patients in the two groups had to have similar

PSA level, clinical stage, and Gleason score

Number of Patients: Total: 163, 5-probe: 82, 6 to 8-probe: 81

Length of Follow-up: 6 months

Efficacy: 5-probe: 39%, 6 to 8-probe: 53%

Measurement of Efficacy: complete glandular ablation

Key Words: 5-probe vs. 6 to 8-probe, probe complications, efficacy

Summary:

The objective of this study is to determine the efficacy for

increased glandular destruction by using 6-8 cryoprobes in place

of the traditional 5 probes.The results of the study demonstrate

that using 6-8 cryoprobes has 3.5 times higher odds of obtaining

near total destruction over the traditional use of 5 cryoprobes.

While there was a concern that more probes would create more

30

P R I M A R Y C R Y O A B L A T I O N P R I M A R Y C R Y O A B L A T I O N

cases.At the 10 year follow-up, 64%, 75% and 84% of patients

were disease free with 0.5, 1.0, and 2.0 PSA ng/mL thresholds.

Overall morbidity rates were low with no operative deaths. 9

patients had a stricture or bladder neck contracture and 2

patients had a prostate abscess, most likely due to the large size

of the gland. One patient had a prostate rectal fistula. 90% of the

patients were continent post surgery and 10% retained some

normal erectile dysfunction. However, 50% of patients had some

return of normal function beginning in 6 months.The results of

the study suggest that cryoablation of the prostate is a minimally

invasive, alternative treatment of primary cancer of the prostate.

The results also demonstrate that cryoablation of the prostate is

the treatment of choice for radiation failure patients whose cancer

is still confined to the prostate gland.

13."CRYOSURGERY OF THE PROSTATE: TECHNIQUES

AND INDICATIONS"

Author: Cohen JK

Institution: Department of Urology,Allegheny General Hospital,

Pittsburgh, Pennsylvania

Date/Publication: 2004, Reviews in Urology; 6:supplement 4):

S20-S26

Indication: Primary & salvage

Number of patients: not stated

Length of follow-up: 10 years

Efficacy: Salvage 56% @ 10 years

Primary (without previous hormone therapy):

Low risk: 68%

Moderate risk: 63%

High risk: 50%

Primary (without any previous therapy):

Low risk: 63%

Moderate risk: 62%

High risk: 49%

33

are very comparable to similar studies using the same modality

in high-risk patients.This reaffirmed data indicates that cryoablation

is a feasible treatment option in patients with organ-confined

prostate carcinoma who have high-risk features. Because

the results of this study have a short follow-up, a longer followup

is necessary to determine the durability of the treatment.

12."CRYOABLATION OF PROSTATE: 10 YEAR EXPERIENCE WITH 249

CASES"

Author: Fletcher C Derrick, Jr., John J Britton,Alan W Fogle,

Jonathon T Donaldson, Bonner Thomason, Ian Y Marshall,

Stephen Bielsky,William H Holl, George B DelPorto, Paul W

Sanders, Benjamin K McInnes, Raymond Rosenblum, James W

Kellet,Alex Ramsay

Institution: Charleston, SC

Date/Publication: May 21-26, 2005,The 2005 Annual Meeting of

the American Urological

Association Association, San Antonio,TX

Indication: Primary

Number of Patients: 249

Length of Follow-up: 10 years

Efficacy: 64%, 75%, and 84%

Measurement of Efficacy: 0.5, 1.0, and 2.0 PSA thresholds

Morbidity: 3.6% stricture or bladder neck contracture, 0.8%

prostate abscess, 0.4% prostate-rectal fistula, 8% stress incontinence,

2% severe incontinence, and 90% impotent

Key Words: efficacy, long-term follow-up

Summary:

This objective of this study was to determine the efficacy of

cryoablation of the prostate in cases of primary cancer (88.24%

of patients) and radiation failure (11.76% of patients). Patients

had Gleason scores ranging from 5-9 with 34.76% low risk

patients, 38.09% moderate risk patients, and 27.17% high risk

patients. Of the 249 patients, follow-up data was available for 230

32

P R I M A R Y C R Y O A B L A T I O N P R I M A R Y C R Y O A B L A T I O N

Efficacy: 81% immediately following procedure (nadir) 75% at

12 months: low risk: 78%, moderate and high risk: 71%

Measure of efficacy: PSA ≤ 0.4 ng/ml for both primary and salvage

Morbidity Primary:

Incontinence: 3% (requiring pads), impotency: 87% (of those

previously potent), fistula: 0%

Salvage:

Incontinence: 11% (requiring pads), fistula: 0%

Key words: third generation, short term

Summary: This is an initial report of cryoablation using third

technology equipment manufactured by Oncura.The study was

conducted at 11 sites worldwide (average of 11 patients per

site). Initial results are encouraging both in terms of efficacy and

morbidity.The authors conclude that this technology has potential

but further study which includes more follow-up is needed

to prove the real morbidity and efficacy profile.

15."SALVAGE CRYOSURGERY OF THE PROSTATE AFTER RADIATION

FAILURE"

Author: Lim JS and Belldegrun AS

Institution: UCLA Department of Urology

Date/Publication: 2004, Reviews in Urology; 6(supplement 4):

S27:S36

Indication: salvage

Key words: third generation, review

Summary: A review article of the technological advancements

that have occurred in the past 10 years with salvage cryoablation.

The morbidity profile associated with early salvage cryoablation

can not be looked at a representative of modern salvage

cryoablation.The efficacy of the modern treatment, along with

the fact that it is repeatable makes it a preferred treatment

modality for localized recurrent prostate cancer.

35

Negative biopsy rate: 70% (not stated which population this

applies to)

Measurement of efficacy: definition of biochemical failure: any

patient who does not have a nadir < 0.4 ng/ml or who has two

successive rises in PSA after treatment

Key words: efficacy, long term follow-up

Summary: This paper is largely intended as a technology

review. It describes how the technologies have changed since

the early days of liquid nitrogen cryomachines. It also documents

the transient removal of the urethral warmer from the market by

the FDA.The morbidity profile associated with modern cryoablation

is significantly less than that of cryoablation in the 1990s.

The paper also contains significant follow-up information

although the matter in which it is presented makes it confusing.

The number of patients in each group is not stated.The results

are very good for salvage but less so for primary (in comparison

to those of Bahn and Donnelly). It states that the best patients

for cryoablation are those with bulky disease, high risk disease

and those who have failed previous radiation therapy.

14."TREATMENT OF ORGAN CONFINED PROSTATE CANCER WITH

THIRD GENERATION CRYOSURGERY: PRELIMINARY MULTICENTER

EXPERIENCE"

Author: Han KR, Cohen JK, Miller RJ, Pantuck AJ, Freitas DG,

Cuevas CA, Kim HL, Lugg J, Childs SJ, Shuman B, Jayson MA, Shore

ND, Moore Y, Zisman A, Lee JY, Ugarte R, Mynderse LA,Wilson TM,

Sweat SD, Zincke H, Belldegrun AS.

Institution: Multicenter trial led by the UCLA Department of

Urology

Date/Publication: October 2003, Journal of Urology. 170(4 Pt

1):1126-30.

Indication: Primary & salvage

Number of patients: 122 (106 with efficacy data)

Length of follow-up: 12 months

34

P R I M A R Y C R Y O A B L A T I O N P R I M A R Y C R Y O A B L A T I O N

Focal Cryoablation

1. "THE MALE LUMPECTOMY: RATIONALE FOR A CANCER TARGETED

APPROACH FOR PROSTATE CRYOABLATION. A REVIEW"

Author: Onik G

Institution: Division of Surgical Imaging, Center for Surgical

Advancement, Department of Surgery and Urology, Celebration

Health in Celebration, Florida

Date/Publication: Aug. 2004,Technology in Cancer Research

and Treatment Vol.3 (4)

Indication: Focal

Patient Selection: Patient must be potent prior to treatment and

the prostate cancer had to be confined to a single prostate lobe

Number of Patients: 9

Length of Follow-up: 36 months

Efficacy: 100%

Measurement of Efficacy: Stability of PSA

Morbidity: 22% impotent, no instances of other complications

previously described with cryosurgery such as obstruction,

incontinence, penile numbness or fistula formation

Measurement of Morbidity: measured 1 year after surgery and

up to 36 months

Key Words: focal, male lumpectomy, potency

Summary:

Since impotence and incontinence affect the male self image as

much as the loss of a breast does in a woman, it is worthwhile to

investigate the feasibility of a male lumpectomy.The lumpectomy

shows that quality of life can be successfully integrated into cancer

treatment.While the majority of prostate cancer cases are

multi-focal, pathological literature indicates that 35% of prostate

cancer is solitary and unilateral.This presents an opportunity for

focal treatment.There has been little prior mention of focal treatment

since it had little clinical significance with treatments

aimed at total gland removal or destruction (such as surgery or

radiation).Through improved gland sampling and biopsies, the

chances of missing a significant multi-focal tumor have been

diminished.With uni-focal cases identified, cryoablation can be

37

F O C A L C R Y O A B L A T I O N

16."PILOT EXPERIENCE WITH REAL-TIME ULTRASOUND GUIDED

PERCUTENAOUS RENAL MASS CRYOABLATION"

Institution: Departments of Radiology, University of Virginia

Health Sciences Center, Charlottesville,Virginia

Date/Publication: April 2004, Journal of Urology171(4):1620-3.

Indication: Renal

Number of patients: 3

Length of follow-up: 2 months

Efficacy: 100 %

Measure of efficacy: contrast enhancement

Morbidity: none

Key words: ultrathin, initial, pilot

Summary: Embryonic results from renal cryoablation using

ultrathin 17 gauge cryoprobes are presented.The study population

is extremely small (3 patients) but all were discharged the

day following cryoablation. Post operative pain management was

done with oral non-narcotic medications. In MRI scans preformed

6-7 weeks post cryoablation no patients had contrast

enhancement.The procedure appears to be promising but more

study is needed to definitively show that small probe cryoablation

is equivalent to larger probe cryoablation.

36

P R I M A R Y C R Y O A B L A T I O N

"minimal" procedure on the side opposite the cancer.The results

demonstrate that the approach is successful in local cancer control,

with no evidence of local cancer recurrence in any patients.

This has great significance since the patient population was not

selected to ensure success as many of the patients had moderate

to high risk features.A major concern for focal cryosurgery is the

biopsy since focal cryoablation leaves some prostate tissue

untreated.The results indicate that the procedure has extremely

low morbidity. Focal cryosurgery is advantageous over RP nervesparing

since it has the ability to be repeated, has a higher rate

of potency when preserving one nerve bundle, and the rate of

potency returns faster with cryotherapy.While a longer followup

is needed, if the results are continually confirmed nerve-sparing

cryosurgery could have a significant impact on the treatment

of prostate cancer.

39

F O C A L C R Y O A B L A T I O N

used as a safe and effective treatment with its inherent ability to

be tailored to the extent of the patients' disease.The results of

this study confirm cryoablation's efficacy as all patients were disease

free and the majority maintained potency.The results

demonstrate cryolumpectomy superiority over bilateral nerve

sparing RP, brachytherapy, and external beam radiotherapy. In

conclusion, preliminary results have shown that a procedure

which effectively targets the cancerous portion of the prostate

gland while limiting the patient morbidity is possible.

2. "FOCAL "NERVE-SPARING" CRYOSURGERY FOR TREATMENT OF

PRIMARY PROSTATE CANCER: A NEW APPROACH TO PRESERVING

POTENCY"

Author: Onik G, Narayan P,Vaughan D, Dineen M, Brunelle R

Institution: Division of Surgical Imaging, Center for Surgical

Advancement, Department of Surgery and Urology, Celebration

Health in Celebration, Florida

Date/Publication: July 2002, Urology Vol. 60 (1)

Indication: Focal

Patient Selection: Patient must be potent prior to treatment

and the prostate cancer confined to a single prostate lobe

Number of Patients: 9

Length of Follow-up: ranging from 6 to 72 months (mean 36)

Efficacy: 100%

Measurement of Efficacy: Stability of PSA

Morbidity: 22% impotent (2 of 9), no instances of other complications

previously described with cryosurgery such as obstruction,

incontinence, penile numbness or fistula formation

Measurement of Morbidity: measured 1 year after surgery and

up to 36 months

Key Words: focal, potency, nerve-sparing RP

Summary:

Focal "nerve-sparing" prostate cryosurgery is a unique combination

of an aggressive treatment on the side of the cancer, yet a

38

F O C A L C R Y O A B L A T I O N

 

 
 
 
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