localizedprostatecancer - maple leaf hifu · 3 the prostate is a male genital...

www.hifu.ca1-877-370-4438

High Intensity Focused Ultrasound Treatment forLocalized Prostate Cancer

Patient Information

Printed in Canada

Ablatherm_DK_revi_April15.qxd:patient 15x21-FR.qxd 4/16/08 9:17 AM

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CONTENT

Introduction................................................................................................................................................................................................................ 1

The prostate ................................................................................................................................................................................................................ 2

What is cancer?............................................................................................................................................................................................... 3

Prostate cancer ................................................................................................................................................................................................. 3

Assessment and diagnosis .................................................................................................................................................. 4

Classification ............................................................................................................................................................................................................ 5

Treatments of localized prostate cancer................................................................................ 6

About Ablatherm® HIFU treatment ...................................................................................................... 8

Ablatherm® HIFU treatment step by step ........................................................................ 14

The benefits ......................................................................................................................................................................................................... 16

Canadian experience .................................................................................................................................................................17

Do I Qualify? ...................................................................................................................................................................................................18

You have just been diagnosed with prostate cancer. You probablyhave many questions concerning your disease, treatment options,and the possible effects on your future.

This brochure contains information on prostate cancer, itsdiagnosis, and the various treatment options available, includingHigh Intensity Focused Ultrasound (HIFU). It will also explainthe disease and help you to understand how HIFU could be rightfor you.

After reading this, you and your family will have a better under-standing of the disease and why treatment with Ablatherm® HIFUis safe, effective, and has fewer side effects than other forms oftreatment. Comprehensive patient information can also be foundat www.hifu.ca.

Introduction

The United States Food and Drug Administration has notapproved the Ablatherm® or any HIFU device for use in thetreatment of prostate cancer in the United States and thereis no assurance when or if such approval will be forthcom-ing. The only Ablatherm® HIFU device in North America islocated in Toronto, Canada.

This brochure is for general information purposes only andis not intended as medical advice. Medical advice regard-ing prostate cancer and its appropriate treatment shouldonly be obtained from a qualified licensed physician.Patients needing medical treatment should consult withtheir personal physician.

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The prostate is a male genitalgland, about the size of a chestnut.

It varies in size according to age.Located under the bladder and infront of the rectum, the prostategland forms a type of sheatharound the upper part of the ure-thra (the canal which dischargesurine from the bladder).

Contrary to many generally accept-ed ideas, the prostate is not direct-ly involved in sexual intercourse: itdoes not affect the mechanisms oflibido and erection. However it isinvolved in the ejaculation mecha-nism, since it secretes most of thefluid which is used to transport andactivate sperm.

All body organs are composed ofcells that are specialized to thetype of job that they do. Our cellsare dying and being replaced con-stantly and this process occurs bycell division.

Cancer is caused by a defect dur-ing the division of normal cellswhich turns them into malignant(cancerous) cells. Malignant cellsgrow much faster than healthyones and can spread intosurrounding tissue.

Eventually these growing malig-nant cells will form a mass of tissueknown as a tumor. First located inone organ, a tumor may thenspread to surrounding ones.

When tumor cells are transport-ed through the blood and lymphsystems to reach remote organs,we use the term metastases(from the Greek word meaningdisplacement).

Prostate cancer is the most com-mon cancer in men, responsiblefor one in three of all malecancers.

The aggressiveness of prostatecancer can vary; some cancersdevelop very slowly and have nosymptoms, whereas others spreadquickly, invade surrounding tissue,and form metastases.

The risk of prostate cancer increaseswith age.

Prostate cancer is the most fre-quently diagnosed cancer in NorthAmerica. There are generally nosigns or symptoms during the earlystages of the disease, and theseappear depending on where thecancer is located in the prostateand whether it has spread.

Scrotum

Bladder

Urethra

Penis

Testicle

SeminalVesicle

Rectum

Prostate

Anus

The prostate What is cancer?

Prostate Cancer


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If diagnosed early the chance ofrecovery from prostate cancer isvery high.

Prostate cancer can be suspectedin routine investigations. A doctorwill perform a digital rectalexamination of the prostate to feelfor any abnormalities such ashardness or increased size. A doc-tor will also carry out a blood testto record levels of prostate specificantigen (PSA). PSA is a proteinproduced by both normal andcancerous prostate cells and highlevels of PSA can be a sign ofcancer. The PSA test identifiestumors that cannot be detected bydigital rectal examination (about30% of cases of all prostatecancers).

The only way to confirm the diag-nosis of prostate cancer is to per-form a biopsy. Once a definitediagnosis of cancer has beenmade, the next step is to know theextent of the disease (clinicalstage). This cancer staging helpsdetermine which treatment willwork the best.

After a biopsy has proven the exis-tence of prostate cancer, patientsmay undergo imaging studiesincluding scans as part of theinvestigation. One of the scansthat may be performed is a bonescan. Bone scans rule out thespread of the cancer to the bone.Patients may also undergo MRI orCT scans. These imaging scans tryto detect cancer which has spreadoutside the prostate to otherorgans such as the lymph nodes,the liver, etc. If the patient has T-1or T-2 prostate cancer, these testswill show no spread of the tumoroutside the prostate.

Cancers are diagnosed at differentstages and are classified into:

�� Localized prostate cancer(stages T1 or T2).

The tumor is confined to the prostate (intracapsular).

Stage T1

This cancer has nosigns or symptomsand is not suspected.The prostate feels

normal to the physician upon rec-tal exam. This cancer may bedetected in two ways. The first isby a blood test for high levels ofPSA and later biopsies. The secondis by examining the tissue removedduring treatment of an enlargedprostate.

Stage T2

This is a tumor whichis suspected uponrectal exam. Theprostate has one or

more areas of firmness and laterbiopsies reveal the cancer. The PSAis also usually higher than normal.

� Advanced prostate cancer(stages T3 and T4)

The tumor spreads into surround-ing organs

Stage T3

This is a tumor thathas spread outsidethe prostate and mayhave reached the

seminal vesicles.

Stage T4

This tumor may havespread to the rectumor bladder or to dis-tant organs or bone.

Assessment & diagnosis Classification


the hospital. This technology hasimproved in recent years but there isstill a high chance of impotence andurinary incontinence. Many patientsundergo cryotherapy after unsuc-cessful EBRT. These patients oftenexperience chronic pelvic and/orrectal pain. In addition, holes or fis-tulae between the prostate and rec-tum can occur. These holes are par-ticularly common in patients whohave already been treated withunsuccessful EBRT.

High Intensity FocusedUltrasoundHigh Intensity Focused Ultrasound(HIFU) is a non-invasive treatmentfor localized (contained) prostatecancer. Ultrasound waves arefocused with extreme precisioninstantly and effectively destroyingthe targeted cancerous cells in theprostate.

The ultrasound waves are deliveredvia a probe which is inserted intothe rectum. The treatment lasts anaverage of two hours and is per-formed under spinal anesthesia withintravenous sedation.

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� Treatments for prostate cancerinclude:

Surgery (radical prostatectomy)The whole prostate is removedwith the seminal vesicles (whichproduce semen), the connectedcanals (which carry the sperm),part of the neck of the bladder andthe surrounding lymph nodes. Thissurgical intervention is invasiveand involves the use of generalanesthesia for 3 to 4 hours andhospitalization for a number ofdays. At the localized stage (stagesT-1 or T-2) a radical prostatectomyis usually curative but it frequentlyresults in impotence and can resultin severe urinary incontinence.Like any other major surgery youcan also have complications andcan have a prolonged recoverytime.

External Beam Radiotherapy (EBRT)This treatment involves the use ofradiation (very high energy rays)directed at the prostate gland tokill cancerous cells. Radiotherapydoes not require anesthesia andtreatment is usually done on anoutpatient basis. Patients are usu-ally treated five days per week in acancer clinic over a period ofseven or eight weeks with eachsession lasting a few minutes.Complications include marked

inflammation of the bladderand/or rectum as well as impo-tence as a late complication (6 to12 months after treatment). Lateside effects can also includesoilage of stool because of damageto the rectal sphincter. Recurrentcancer after EBRT is not uncom-mon and is very difficult to treat.

BrachytherapyDuring this treatment 50 – 150small radioactive seeds areimplanted directly into theprostate gland using 20 - 40 nee-dles. This procedure is usuallydone under general anesthesia (2to 3 hours). It is recommended thatthe patient avoid close contactwith children and pregnantwomen for two months after seedimplant. As with EBRT, recurrentdisease is not uncommon and isdifficult to treat. Brachytherapycannot be utilized when a patienthas symptoms of prostate obstruc-tion, when he has a Gleason stageabove 7, or when he has had aprevious transurethral resection ofthe prostate (TURP).

CryotherapyIn cryotherapy, probes are surgicallyplaced into the prostate and thegland is frozen solid. The procedureis done under anesthesia. Thepatient must stay at least one night in

Treatments for localizedprostate cancer

�� What Are the PotentialComplications from theTreatment?

Digestive SystemFor patients in which Ablatherm®

HIFU was the first procedure usedto treat T-1 or T-2 prostate cancer,no digestive system complicationswere reported.

Urinary SystemThe urethra is the channel whichcarries urine from the bladder,through the prostate, and out thepenis. Narrowing of the urethrawhere it passes through the prostatecan appear in the months followingthe treatment. This is due to theforming of scar tissue which nor-mally replaces the treated prostate

tissue. A simple treatment called atransurethral urethrotomy may beneeded to re-establish the normalurethral channel.

ImpotenceA study released in 2007 reported57% retention of sexual potencywith another 17% of patients withpartial potency. These results arebetter than those of patients whohave undergone surgery. In patientstreated with nerve sparing tech-niques, erectile function is retainedin approximately 75%-80% ofcases according to various pub-lished case studies. In addition, themajority of patients who suffer erec-tile dysfunction following treatmentby Ablatherm® HIFU usually will

Potential Complicationsof Ablatherm HIFU


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respond to oral medications (Viagra,Levitra, Cialis). Fortunately, manypatients regain potency six totwelve months after treatment.

IncontinenceAlmost all reports of incontinence aremild and can generally be managedwith drugs and/or muscle training.Most of the symptoms go away inabout one to three months.

There are three types of incontinence:

Type 1: the leakage of urine withmarked straining. This can be con-trolled with medication and pelvicfloor exercises. This type of inconti-nence is temporary usually lastingabout one to three months.

Type 2: the leakage of urine withmild to moderate straining. Thiscan be controlled with medicationand pelvic floor exercises.

This type of incontinence is alsousually temporary usually lastingabout one to three months.

In the first patients treated withAblatherm® HIFU approximately 1 in 12 experienced either Type1 or Type 2 incontinence. Recentadvancements in Ablatherm® HIFUhave resulted in even fewer cases ofintial Type 1 and Type 2 incontinence.

Type 3: severe incontinence.

Type 3 incontinence is essentially nota risk unless patients have alreadybeen treated with radiation orsurgery. It is seen in significantly lessthan 1% of cases for patients whowere treated with Ablatherm® HIFUas a primary treatment for T1 or T2prostate cancer.

� About Ablatherm® HIFU

Ablatherm® HIFU is a non-invasivemedical device which uses HIFU(High Intensity Focused Ultrasound)to treat localized (contained)prostate cancer.

The prostate will be destroyed by the thermal effect of HIFU (tempera-ture rising to 85°C / 185°F), thereforethere is no radiation involved.

� Who should have this type oftreatment?

Your urologist may recommendAblatherm® HIFU if:

• you require treatment for con-tained prostate cancer.

• you have had radiotherapy inthe past and your cancer hasnow returned.

About Ablatherm® HIFU treatment

� Are there reasons why or circumstances in which HIFUtreatment is not a possible option?

Almost none – however, when apatient has an enlarged prostate,hormone therapy may be pre-scribed to reduce the size of thegland so that Ablatherm® HIFUtreatment is made possible.

In some cases Ablatherm® HIFU isnot recommended for men whohave experienced thickening of therectal wall due to previous cancertreatments. Also, if you have a con-firmed latex allergy, HIFU is not atreatment option.

� Who produces Ablatherm®

HIFU?

The Ablatherm® HIFU technologywas developed, in 1989, by theurology department of the HospitalEdouard Herriot in Lyons (France)and INSERM, the French NationalInstitute for Medical Research. It

has been developed on an indus-trial scale by EDAP. The first treat-ment was performed in 1993, andAblatherm® HIFU was given mar-ket approval for Europe in 2000. InCanada, Health Canada gaveapproval for use in March 2003.

As of March 2008, over 15000patients had benefited fromAblatherm®HIFU treatment in176 centers around the world.

� How does Ablatherm® HIFUwork?

The urologist uses the Ablatherm®

HIFU device to treat the prostatecancer. The doctor inserts a probeinto the rectum. This probeincludes an imaging componentwhich allows the doctor to viewthe prostate and adjacent nervebundles on the computer as theprocedure is taking place. Theprobe also includes a transducerwhich emits the focused ultra-sound waves.


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The doctor inputs a treatment planinto the computer which then controls and aims the ultrasoundwaves. These are focused withextreme precision onto the prostate,causing a very brief rise in tempera-ture (around 85° C / 185° F). The targeted tissue is then instantly andeffectively destroyed, while the surrounding tissue is preserved.

The Ablatherm® HIFU machinehas numerous safety checks whichare constantly monitored through-out the treatment to ensure patientsafety. This means that the treat-ment is always delivered to thesame high standard and quality.

� Treatment

You will be asked to come for a con-sultation the afternoon before your

treatment. You will be provided withan enema to be used the morning ofyour procedure. The treatment isperformed under spinal anesthesiawith intravenous sedation to ensureyou are comfortable and that youremain completely still. You will lieon your right-hand side and the doc-tor will place a gel-coated probe intoyour rectum. The doctor maps outyour prostate and the HIFU treatmentcan then start – 400 to 600 shots ofHigh Intensity Focused Ultrasoundwaves are generally given. On aver-age the treatment lasts two hours.

� Why is catheterization needed?

The prostate swells after treatmentand presses on the urethra (canalwhich discharges urine from thebladder) so catheterization toremove urine is necessary until theswelling subsides.

� Is the Ablatherm® HIFU proce-dure painful?

The treatment itself is not painful asit is carried out under spinal anes-thetic. Pain after treatment is rare,although most patients feel a slightdiscomfort which disappears after afew days. The procedure is non-invasive so there are no woundsand patients do not experience theburning sensation often associatedwith radiotherapy.

� What happens after treatment?

Most patients can go back to eat-ing normal food the evening oftreatment. The urinary catheteris removed two weeks later.Medication is prescribed for thefollowing two weeks to preventany infection of the urethra orbladder. In the period after treat-ment you may experience somediscomfort including mild bleedingat the start of urination, frequent

and sometimes urgent urination,urine leakage during physical exer-tion or coughing and sometimesthe elimination of dead cancercells in the urine. Infections withfever are rare but possible andrequire antibiotics. These sideeffects disappear in the weeks fol-lowing the treatment.

� What long-term follow up isrequired?

PSA levels are checked everythree months for the first twoyears following treatment, semi-annually the next two years, andthen annually thereafter. Qualityof life surveys are completedevery six months. All results arerecorded in our patient registry.

� How successful is Ablatherm®

HIFU?

An independent European study of 402 patients with localizedprostate cancer showed that afterAblatherm® HIFU treatment no can-cer was found in biopsy tests for92.1% of low risk patients.

A more recent study confirmed theseresults and involved performingbiopsies on 137 patients. 93% ofthese patients did not show cancer.87% of these patients had constantPSA levels of less than 1.0 ng/ml upto five years after the treatment.

The targeted prostatic volume islocalized with a transrectal ultrasound imaging probe.

Prostate

Bladder At the focal point of the ultrasoundbeam, a sharp temperature risedestroys the cancer cells.

Diameter1.7 mm

Focalpoint

The Ablatherm®HIFU probe is controlled by acomputer to generate the ultrasound waves.


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Over 90% of patients undergoingAblatherm® HIFU treatment willnot require further treatment fortheir prostate cancer. If a patient'scancer returns they have not elimi-nated treatment options as theyremain candidates for Ablatherm®

HIFU treatment, surgery, radiation,or hormone therapy. Ablatherm®

HIFU treatment has a similar suc-cess rate to radical prostatectomybut it is not as invasive and hasfewer side effects.

� What are the side effects?

Studies of Ablatherm® HIFU treat-ment have found few side effects.Only the prostate is destroyedwhile adjacent tissue is preserved.The procedure is non-invasivewhich means it does not involvean incision through the skin..

You will be able to return to nor-mal activity after only a few days.HIFU patients may experience atemporary burning sensation withvoiding, but not the burning sensa-tion associated with radiotherapy.

� Ablatherm® HIFU treatmentafter radiotherapy

Ablatherm® HIFU treatment canbe given to patients whose cancerhas returned after radiotherapy,although some patients are not suit-able due to abnormal thickening ofthe rectal wall (about 5% of cases)or because the cancer has spread.

Complication rates are significantlylower with Ablatherm® HIFU thanwith salvage cryotherapy or salvagesurgery. Severe Type 3 incontinenceoccurs in 8% of Ablatherm® salvagetreatments as opposed to 50% ormore with other treatment options.Similarly, impotence occurs inapproximately 40% of Ablatherm®

salvage treatments which is muchbetter than the rates seen in salvagecryotherapy and salvage surgery.

Unlike treatment with salvagecryotherapy or salvage surgery, therehave been zero incidents of rectal fistulae in patients treated withAblatherm® HIFU since 2002.

Single 4.0 MHZ transducer compro-mises image quality and treatmentresults.

ABLATHERM® SONABLATE® 500

Dual US Transducers in treatmentprobe provide superior 7.5 MHZreal-time imaging while allowingoptimum high intensity shock waveproduction with separate generator.

Image Quality

Willing to treat larger prostates butfrequently require TURP post treat-ment or prolonged catheterization.

At Maple Leaf HIFU, fewer than 2%of patients have required a TURPprior to Ablatherm® HIFU.

TURP required? (A TURP is a surgical procedure with somerisk of complications.)

No data available on preservation oferectile function with suboptimalvisualization of 4.0 MHZ probe.

Superior imaging allows precisevisualization and localization ofneurovascular bundles allowingimproved nerve sparing.

Nerve Detection

Requires physician input to reducepower and, in some cases, thiscould result in a failure to complete-ly treat prostate tissue.

Computer controlled. Auto detec-tion of possible danger to rectumallows uniform application of ener-gy level to effectively treat prostate.

Energy Control

Probe must be manually placed andmanipulated. Very operator depen-dent.

After initially positioned by physician,probe is fine tuned by robotic controland image recognition software toensure accurate treatment. Allows veryaccurate delivery of energy to toler-ance of 0.1 mm. Fully automated.

The Probe

Must vary energy based on visualclues to avoid periprostatic tissueinjury. Significant risk of rectalinjury.

Three scientifically tested and opti-mal energy levels for de novo, radi-ation failure, or HIFU retreatmentconditions.

Power Adjustment

Probe geometry poorly configures toprostate anatomy.

Variable height of focal area in single probe allows energy to bedelivered in pattern conformed toprostate anatomy

Precision

Safety devices require constantoperator attention to monitor limitedsafety parameters and adjust deviceenergy output to prevent rectalinjury (fistula) or injury to surround-ing tissue.

Includes external motion detector, rec-tal wall temperature monitoring, rectalwall thickness and “probe to rectalwall” distance protect against rectal orpreprostatic tissue injury. Automaticdisengagement of firing device ifparameters are violated. Image guidedrobotic fine tuning of probe position toensure effective treatment.

Safety Features

Poor image quality and small treat-ment field extend treatment time upto 8 hours with an average treat-ment time of 2.8 hours.

Integrated imaging with single probeand automated control keep treat-ment time under 2 hours in themajority of cases.

Treatment Time

Key Differences Between Ablatherm® HIFU & Sonablate® 500


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Ablatherm® HIFU Treatment step by step

1 The patient lies down on his righthand side and stays in this positionthroughout the treatment.

2 This picture illustrates the positionof the probe in relation to the rectum and the prostate (here in orange colour).

3 Due to the closeness of theprostate to the rectal wall, thetreatment is performed optimallyusing the transrectal approach.

4 The probe is lubricated and theninserted into the rectum via theanus. The prostate is then accessi-ble for ultrasound treatment.

5 The imaging transducer in themiddle of the probe allows avery precise three-dimensionalreconstruction of the area to betreated and to be seen on amonitor.

6 The whole prostate is scannedand visible on the computerscreen.

7 On the screen, the surgeonplans each step of the treatmentwith a microscope precision.

8 Finally, the machine producesHigh Intensity FocusedUltrasound waves which destroythe cancer cells.


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Please consult your urologist for more information or log on to the Maple Leaf HIFU website at www.hifu.ca

The benefits

The treatment of localized prostate cancer with Ablatherm® HIFU is atreatment option with many advantages:

� Non-invasive treatment

� Destruction of the cancerous tissue with minimal effect to thesurrounding organs

� Treatment does not use radiation

� Treatment can be performed under spinal anesthesia

� Treatment can be performed in one session

� No hospital stay required

� Treatment can be repeated

� Other therapeutic alternatives can be considered if results areunsatisfactory

� Ablatherm® HIFU can be used for the treatment of local recur-rences (i.e. after external beam radiotherapy)

PSA NADIR < 0.5 NG/ML AT 3 MONTHS BY T STAGE

≤ T-2 84.7%

T-1 & T-2-A 86.9%

Canadian experience

Maple Leaf HIFU has been treating patients since May 2005. Our resultshave proven to be durable to 30 months and are detailed below:

PSA NADIR < 0.5 NG/ML AT 3 MONTHS BY GLEASON GRADE

Gleason ≤ 6 85.2%

Gleason 6 and 7 (3+4) 85.0%

Gleason ≤ 7 (4+3) 82.0%

We analyzed the following subset ofour patient population:

� T1 & T2

� Gleason 6 and 7 (3+4)

� PSA < 10

� volume less than 40 cc.

Of the patients that fit this profile,87.7% had a PSA < 0.5 ng/ml at3 months.

2.1% of the group represented bio-chemical (PSA nadir + 2.0) orpathological (Biopsy proven localrecurrence/persistence) failures.

The remaining 10.2% currentlyshow no evidence of biochemi-cal or pathological failure. It isprobable that the success ratesfor this group as a whole willprove to be even higher than thecurrent 87.7%.


If you answered YES TO ALL OFTHESE QUESTIONS, then you may qualify. The next step is tocontact our office to discuss thetreatment with one of our patientcare coordinators. Please contact

us by phone at 1-877-370-HIFU(1-877-370-4438) toll-free, or(905) 648-4347, or by e-mail: [email protected]. Comprehensivepatient information can also befound at www.hifu.ca.

Do I Qualify?

Do I Qualify for Ablatherm® HIFU?

I have been advised to have radical surgery or curative radiation for myprostate cancer.

yes no

� � I am medically well enough to travel/fly to our treatment center.

� � I am able to have a spinal anesthetic.

� � I am not allergic to latex

The United States Food and Drug Administration has notapproved the Ablatherm® or any HIFU device for use in thetreatment of prostate cancer in the United States and there isno assurance when or if such approval will be forthcoming.The only Ablatherm® HIFU device in North America is locatedin Toronto, Canada.

This brochure is for general information purposes only and is notintended as medical advice. Medical advice regarding prostatecancer and its appropriate treatment should only be obtainedfrom a qualified licensed physician. Patients needing medicaltreatment should consult with their personal physician.

Notes


www.hifu.ca

For further information aboutAblatherm®HIFU treatment visit

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