Prostate Cryotherapy Patient Information Booklet · medication and other aids to help men whose natural ability to obtain an erection is lost or reduced. This condition – called

Prostate CryotherapyPatient Information Booklet

A clinically proven, minimally invasive, radiation-free cancer treatment thatprotects your quality of life

“

“The more you know about prostate cancertreatment options, the better prepared youwill be to choose the best prostate cancertreatment with the help of your doctor.

“I had radiotherapy for five weeks, everyworking day, and the round trip was twohours per day (ten hours per week). I feltso sick I wanted to pack it in before thetreatment was complete. For two-and-ahalf months, I had no quality of life.

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“If you have the right treatmentat the right time, you can live a perfectly normal life. Earlydiagnosis is important.

Prostate Cancer Patient Comments

“ “If prostate cancer iscaught in the earlystages, cryotherapybecomes an optionfor most men.

“I liked the idea of cryotherapy as it was less invasive, and if thecancer should return at a later date, the treatment can safelybe repeated. This is a great comfort to me and my family.

“ “When the cancer came back after radiation, Ihad cryotherapy. Looking back, if I had beenoffered cryotherapy instead of radiotherapy,that would have been my first choice.

“

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Introduction

Being diagnosed with prostate canceris a time of concern for you and yourloved ones, but medical advancesmean that today, the chances of youbeating your cancer are better thanever before.

Your doctor will discuss with you the different treatments available. Itis important that you research all theoptions and talk them over with yourfamily to make sure you select themost appropriate one for you andyour lifestyle.

This booklet is designed to help you inthis process and provide you with moreinformation on cryotherapy – atechnique which uses extremely coldtemperatures to kill cancer cells.Each year, thousands of prostatecancer patients choose cryotherapybecause it is proven to cure cancer,avoids the need for radiation orsurgical removal of the prostate, andoffers quality-of-life benefits oversurgery and other forms of treatment.

For more information, please visitwww.prostate-cancer-institute.com 3

What is cryotherapy?

Cryotherapy is a minimally invasivetreatment (no incisions) that uses extremelycold temperatures to kill cancer tumors.Cryotherapy is widely used around theworld and has over ten years’ clinicalexperience to support its safety andeffectiveness.1 It is also recognized by boththe American Urological Association andthe European Association of Urology as atreatment for prostate cancer.

To treat a patient with cryotherapy, doctorscreate iceballs using compressed gas andspecially designed thin probes which deliverthe ice to the target area. These iceballsare very precisely shaped and positioned tofreeze the prostate and destroy all of thecancerous tissue. The process is carefullycontrolled by your doctor who usesultrasound imaging systems andtemperature monitors to help ensure thatthe healthy tissue surrounding the prostateis not affected by the cold temperatures.

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I am now three years post cryotherapy andmy PSA remains low. I still manage to go on holidays and enjoy my quality of life.

1. Cohen et al. Urology (2008)

Will cryotherapy cure my cancer?

If your doctor considers you to be suitable forprostate cryotherapy, it is extremely likely thatthe procedure will cure your prostate cancer.

The effectiveness of cancer therapies ismeasured in terms of the number of yearspatients enjoy being disease-free aftertreatment. The graph opposite shows thepercentage of patients who are cancer-free a number of years after treatment. It demonstrates that cryotherapy is atleast as effective as any other therapy –including surgery – at giving patients a life free from cancer.

Since prostate cancer treatments havesimilar survival rates, side effects andquality of life are important considerationswhen choosing your treatment.

Biochemical Disease-Free Survival (% Patients) After Treatment for Primary Prostate Cancer

A high number meansmore people were disease-free at time of follow up*

The graph shows disease-free survival for patients, as published in medical journals by theirdoctors. The follow-up period for established treatments, including cryotherapy, is ten years.Follow-up times for RRP and HIFU are shorter, because they are newer treatments and haveless clinical experience.

Source: Published results for low and intermediate-risk prostate cancer patients:

Radical Prostatectomy: European Association of Urology Guidelines on Prostate CancerRRP: Patel et al. BJU Int (2008)EBRT: Alicikus et al. Cancer (2010); Talcott et al. JAMA (2010); Koukourakis et al. Anticancer Research (2006)Brachytherapy: Machtens et al. World J Urol (2006)HIFU: Misraï et al. World J Urol (2008); Crouzet et al. Eur Urology (2010)Cryotherapy: Cohen et al. Urology (2008)

100

90

80

70

60

50

40

30

20

10

0Radical

Prostatectomy(Conventional Surgery)

Robotic Radical Prostatectomy

(RRP)

External BeamRadiotherapy

(EBRT)

Brachytherapy High IntensityFocused

Ultrasound(HIFU)

Cryotherapy

Lowest reported result

Highest reported result

*10

years*7

years*

10years

*10

years*5

years*8

years*

10years

5For more information, please visitwww.prostate-cancer-institute.com

What are the benefits of cryotherapy?

Cryotherapy offers many advantages overother treatment options, including:

• A minimally invasive (no incisions),curative treatment

• 10-year clinical data1 supports safety andeffectiveness in treating prostate cancer

• Single treatment, performed on outpatientbasis or requiring just one overnight stay

• Short hospital stay reduces risk ofhospital-acquired infection

• Short recovery time permits rapid returnto everyday life

• Lower risk of incontinence2 (leaking urine)than with any other therapy

• May improve urinary function in patientsexperiencing problems prior to cryotherapy3,4

• Minimal or no pain

• No need for radiation or radioactivesubstances and risk of associated sideeffects (eg secondary cancer)

• Low risk of rectal damage2 or irritation

• Can be used when other treatments, such as intensity modulated radiationtherapy (IMRT), external beamradiotherapy (EBRT) and brachytherapyhave failed to cure prostate cancer

What are the risks and side effects ofcryotherapy?

Your doctor will advise you that any medicalprocedure has risks associated with it.However, cryotherapy avoids many of therisks and complications of other therapies.The potential side effects of curativeprostate cancer treatments includeincontinence (although the risk of this isvery low with cryotherapy) and erectileproblems. These are discussed in moredetail later in this booklet.

How long does the procedure take?

A prostate cryotherapy procedure usuallytakes between 90 minutes (1½ hours) and120 minutes (2 hours).

How long will I need to be in hospital?

Prostate cryotherapy can be performed onan outpatient basis. This means that you donot need to stay in hospital for more than afew hours after your treatment, and noovernight stay is required. Sometimes oneovernight stay is preferred, but this isdependent on local arrangements or theindividual case.

1. Cohen et al. Urology (2008) 2. Langenhuijsen et al. European Urology (2009)3. Kimura et al. Urology (2010)4. Malcolm et al. J Urol (2010)

“ “Straightaway, I was able to resume normallife activities; this was important to me asmy wife is disabled and I am her primarycaregiver. I feel absolutely wonderful.

How will I feel after the procedure?

You may feel some slight discomfortimmediately after the procedure, but youwill be given pain medication for this and itwill improve very quickly. You will have adrainage catheter left in place for a fewdays until you are able to urinate. You willbe shown how to manage the catheterbefore you return home.

Most patients feel a great sense of reliefthat their cancer has been treated and somefeel quite emotional as a result of this.

How long before I can return to work?

Your doctor will advise you on the time youshould plan to take off. Because cryotherapydoes not involve open surgery, most patientsare able to return to work and an activelifestyle once they no longer need theircatheter – typically a week or less.

What about other activities, such assports?

Your doctor will advise you on when it isappropriate to resume active hobbies andsports, but usually this will be a week or twoafter your procedure.


Will cryotherapy impact my sex life?

Your doctor may have explained to you thatall curative treatments for prostate cancercan affect a man’s ability to obtain andmaintain an erection. This risk can seemdaunting, but it is important to rememberthat there have been significant advances inmedication and other aids to help menwhose natural ability to obtain an erection islost or reduced. This condition – calledimpotence or erectile dysfunction (ED) – isvery common among middle-aged men(including those who have not had prostatecancer) and today there is lots of helpavailable to ensure they are still able to leada fulfilling sex life. After cryotherapy, manypatients have had success regainingerections through what is called penilerehabilitation, which combines medication(eg Viagra®) and a vacuum device. Withpenile rehabilitation, close to 50% of menwere able to regain potency after one year.1

The graph opposite shows the relative risksof impotence with different prostate cancertreatments, as shown by a variety of studies.

“ “

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I feel fantastic, really I feelgreat. I am going to the gymand keeping very active.

1. Ellis et al. Urology (2007)

Viagra is a registered trademark of Pfizer Inc.

Radiotherapy had affected that, I wasalready impotent so that was not a keyconcern for me. There is more to life.Only recently, we buried a youngerguy – mid-50’s – with prostate cancer.It’s better to be alive.

Risk of Impotence (%) After Treatment for Primary Prostate Cancer

A low risk means less likelihood of impotence100

80

60

40

20

0Radical



(RRP)


(EBRT)


Ultrasound(HIFU)

Cryotherapy


Radical Protatectomy: European Association of Urology Guidelines on Prostate CancerRRP: Patel et al. BJU Int (2008)EBRT: Talcott et al. JAMA (2010); Koukourakis et al. Anticancer Research (2006)Brachytherapy: Machtens et al. World J Urol (2006)HIFU: Warmuth et al. Eur Urology (2010)Cryotherapy: Langenhuijsen et al. European Urology (2009); Finley et al. Urol Clin N Am (2010)




brachytherapy, urinary symptoms becamemore of a problem for patients after theirtreatment. With the cryotherapy patients,urinary symptoms were a problemimmediately following the procedure, butpatients recovered quickly, reaching 97% oftheir pre-treatment/baseline QOL score within12 months of their treatment, and then goingon to exceed their baseline score at 36months. In other words, their urinarysymptoms improved after cryotherapy. Thedoctors who conducted the study believe thatthis is due to the cryotherapy reducing thebladder obstruction and leading to asubsequent improvement in the patients’quality of life.

Over the years, I realize I need to urinatemore than I used to, and I’m worried thatmy cancer treatment might make thisworse.

Many prostate cancer patients find emptying(“voiding”) their bladder difficult. Even whenthey have the urge to urinate, they cannot doso effectively, and this means the need “to go”is typically only satisfied for a short period oftime. Some patients also experience irritationwhen they urinate. These problems arereferred to “urinary symptoms” by urologistsand can be caused by a blockage to the outletflow of urine.

A recent study1 looked at how differentprostate cancer therapies affect their patients’health-related quality of life (QOL). Theyidentified urinary symptoms as one of thefactors which has an impact on a patients’quality of life. Frequent visits to the bathroomduring the day are inconvenient and can beembarrassing, while, at night, they lead todisturbed sleep patterns for the patient andspouse. Patients in the study were asked togive a score as to how much urinarysymptoms affected their quality of life beforetheir prostate cancer treatment (whichbecame their baseline score) and then theyscored this again at regular intervals aftertheir treatment. The study showed that withsurgery (conventional and robotic) and

1. Malcolm et al. J Urol (2010)

Change in Urinary Symptoms (% Return to Quality-of-Life Baseline) in Prostate Cancer Patients

120

100

80

60

40

20

0Radical



(RRP)

Brachytherapy Cryotherapy

Source: Malcolm et al. J Urol (2010)

6months

12months

36months

6months

12months

36months

6months

12months

36months

6months

12months

36months

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I go to bed every evening and sleep right through, I never needto get up during the night to go to the toilet, which is great!

11

% o

f Bas

elin

e

For more information, please visitwww.prostate-cancer-institute.com

Will I need to wear incontinence padsafter the procedure?

The other urinary-related side effect oftreatment for prostate cancer isincontinence (leaking urine). This is one ofthe most common side effects of treatmentfor prostate cancer. Many men need to wearand regularly change pads as a result ofleaking urine; this is a significant hurdle forcancer patients in regaining a good qualityof life after their treatment. It isparticularly difficult for men who havepreviously enjoyed a full social life, outdoorsports and other activities.

The same study1 that looked at urinarysymptoms, also looked at urinaryincontinence in terms of its impact onquality of life; the results are shown in thegraph opposite. Once again, thecryotherapy group saw much betterresults than the other treatment groups(including robotic radical prostatectomy). The cryotherapy group recovered to 99% oftheir baseline score within six months andwent on to improve upon their baselinescore by an average of 13% over three years.

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“I feel wonderful! After the procedure I had nopain and felt great. When my catheter wasremoved, my body adjusted and today, I feelnormal – I need no pads.

1. Malcolm et al. J Urol (2010)

Change in Urinary Incontinence (% Return to Quality-of-Life Baseline) in Prostate Cancer Patients

120

100

80

60

40

20

0Radical



(RRP)

Cryotherapy

Source: Malcolm et al. J Urol (2010)

Overall, the risk of incontinence is significantly lower with cryotherapy than with any othercurative treatment, as shown by the graph on page 15. In addition, as explained opposite, manypatients who suffer from incontinence before their treatment, see an improvement in symptomsafter cryotherapy.1,2

6months

12months

36months

6months

12months

36months

Brachytherapy

6months

12months

36months

6months

12months

36months

1. Malcolm et al. J Urol (2010)2. Kimura et al. Urology (2010) 13

% o

f Bas

elin

e

For more information, please visitwww.prostate-cancer-institute.com

I heard cryotherapy is an experimentaltherapy – is that true?

No. Cryotherapy is recognized by both theAmerican Urological Association and theEuropean Association of Urology as atreatment for prostate cancer and has overten years’ clinical data to support its safetyand effectiveness.1 In the USA, cryotherapyhas FDA clearance and is covered byMedicare and most insurance companies.

Am I suitable for cryotherapy?

While your doctor can help determine if youare a good candidate, prostate cryotherapy isused to treat all stages and all types oflocalized prostate cancer (cancer which hasnot spread outside the prostate). Prostatecryotherapy is also used to treat patientswho have failed radiation therapy.

“ “If I had to say which treatment would betop of my list, it would be cryotherapy. Ihave a good quality of life, and there is agood chance I could have the treatmentagain, if necessary.

1. Cohen et al. Urology (2008)

Risk of Incontinence (%) After Treatment for Primary Prostate Cancer

A low risk means less likelihood of incontinence50

40

30

20

10

0Radical



(RRP)


(EBRT)


Ultrasound(HIFU)

Cryotherapy




Radical Protatectomy: European Association of Urology Guidelines on Prostate CancerRRP: Patel et al. BJU Int (2008)EBRT: Talcott et al. JAMA (2010)Brachytherapy: Machtens et al. World J Urol (2006)HIFU: Warmuth et al. Eur Urology (2010)Cryotherapy: Langenhuijsen et al. European Urology (2009); Finley et al. Urol Clin N Am (2010)


The Prostate Gland

The prostate is part of the male sex gland.The prostate opens into the urethra justbelow the bladder. During ejaculation itsecretes an alkaline fluid that forms partof the semen.

Cancer growing within the prostate mayhave the effect of disrupting the flow ofurine as it can place pressure on theurethra that passes through the prostate.However, this problem may also be causedby benign prostatic hyperplasia orhypertrophy (BPH). BPH is a benign (non-cancerous) condition which affects manymen as they get older. Since the prostatecontinues to grow after puberty, it mayeventually apply pressure on the urethra,causing weak or interrupted urine flow.BPH can also make emptying the bladderdifficult, causing urgency and frequentvisits to the bathroom. BPH is usuallycontrolled by drugs or treated by a simplesurgical procedure.

Like prostate cancer, BPH can also causean elevation in PSA levels, which can bemisleading. If a PSA test gives cause forconcern, it is usually followed by a biopsy to clarify what is happening in the prostateand determine if prostate cancer or BPH isthe cause.

Prostate cancer is the most common formof cancer in men over the age of 60.

Prostate Gland

Bladder

Rectum

Testicle

Bladder

Urethra

Seminalvesicle


Prostate: A gland in the male reproductive system just below thebladder. The prostate surrounds part of the urethra, the canal thatempties the bladder, and produces a fluid that forms part of semen.

Prostate cancer staging: Stage I: The cells closely resemble normal cells and the glandfeels normal to the examining finger. Stage II: More of the prostate is involved and a lump can be feltwithin the gland. Stage III: The tumor has spread through the prostate wall and thelump can be felt on the surface of the gland.Stage IV: The tumor has invaded nearby tissue.

Prostatectomy: Surgical removal of the prostate.

PSA: Prostate specific antigen, a protein produced by the prostate.

PSA test: The PSA test measures levels in the blood and is used tohelp detect prostate cancer as well as to monitor the results oftreatment. Elevated PSA may be an indicator of prostate cancer.

Radiation therapy (Radiotherapy): Uses high-energy radiation tokill cancer cells and shrink tumors. Radiation may come from amachine outside the body (external beam or intensity modulatedradiation therapy) or from materials placed inside the body(internal radiation therapy, implant radiation, or brachytherapy).

Radical prostatectomy: The surgical removal of the entireprostate gland, the seminal vesicles and nearby tissue.

Rectum: The short tube located at the end of the large intestine,which connects the intestine to the anus.

Robotic radical prostatectomy: Instead of directly moving theinstruments, the surgeon uses a computer console to manipulatethe instruments attached to multiple robot arms. The computertranslates the surgeon’s movements, which are then carried outon the patient by the robot.

Stage: The extent of a cancer. See also Prostate cancer staging.

Transrectal ultrasound (TRUS): the use of sound waves to createa picture of the prostate on a screen to help examine the conditionof the prostate and guide insertion of the cryotherapy probes.

Urethra: The tube that carries urine from the bladder to theoutside of the body.

Urinary incontinence: Involuntary loss of urine associated with asudden strong urge to urinate.

Urinary symptoms: Problems associated with obstruction to flowof urine, usually caused by BPH.

Glossary of Terms Ablation: The destruction of tissue by the application of extremecold, heat or light (laser).

Anesthesia: The loss of sensation and usually of consciousnessartificially produced by the administration of one or more agentsthat block the passage of pain impulses along nerve pathways tothe brain.

Benign prostatic hyperplasia/hypertrophy (BPH): A non-cancerouscondition that can affect PSA levels and cause enlargement of theprostate. This growth of the prostate can press on the urethra andcause urination and bladder problems (urinary symptoms).

Biopsy: The removal and examination of a sample of tissue fordiagnostic purposes.

Brachytherapy: A procedure in which radioactive material sealedin needles, seeds, wires, or catheters is placed directly into ornear a tumor.

Cancer: A malignant and invasive growth or tumor.

Catheter: A tube inserted into the bladder to temporarily drainurine into a plastic bag. Depending upon your doctor’srecommendation, a catheter is normally kept in place 1-2 weeksafter prostate cryotherapy.

Cryotherapy: The destruction of tissue by the application ofextremely cold temperatures.

Erectile dysfunction (ED): The loss of the ability to produce and/orsustain an erection. Often referred to as “impotence”. In manycases, an erection can be achieved with assistance.

External Beam Radiation Therapy (EBRT): See Radiation therapy.

Fistula: An abnormal passage from a hollow organ to the bodysurface or from one organ to another.

Gleason score: A system of grading prostate cancer cells basedon how they look under a microscope. Gleason scores range from2 to 10 and indicate how likely it is that a tumor will spread.

Impotence: See Erectile dysfunction.

Incontinence: See Urinary incontinence.

Intensity-modulated radiation therapy (IMRT): See Radiationtherapy.

Perineum: The area of skin between the scrotum and the anusthrough which the doctor inserts the ultra-thin cryotherapyprobes. After the procedure, a dressing is applied and the tinyholes heal rapidly.

Notes


Notes

Date PSA Reading

Test Results Record

Date PSA Reading

Date Gleason Score

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Ask for a PSA, record the result and monitorthe trend no less than once a year


Patient number:

Doctor’s name

Doctor’s contact number

Nurse’s name

Nurse’s contact number:

Email:

Appointment dates

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Documents

Prostate Cryotherapy Patient Information Booklet · medication and other aids to help men whose natural ability to obtain an erection is lost or reduced. This condition – called