Prostate Tissue Ablation - HIFU Total Care · High Intensity Focused Ultrasound High Intensity Focused Ultrasound (HIFU) is a minimally-invasive ablation which can be used for cases

High Intensity Focused Ultrasound forProstate Tissue Ablation

Patient Information

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CONTENT

Introduction................................................................................................................................................................................................................ 3

The prostate ................................................................................................................................................................................................................ 4

What is cancer? ............................................................................................................................................................................................... 5

Prostate cancer.................................................................................................................................................................................................. 5

Assessment and diagnosis .................................................................................................................................................. 6

Classification ............................................................................................................................................................................................................ 7

Treatments of localized prostate cancer ................................................................................ 7

About Ablatherm HIFU procedure ............................................................................................... 8

Ablatherm HIFU procedure step by step.................................................................. 12

The benefits ......................................................................................................................................................................................................... 14

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You have been diagnosed with prostate cancer and your urologist hassuggested an ablation using High Intensity Focused Ultrasound.

You probably have many questions concerning your disease, treatmentoptions and their possible effects.

This brochure contains information on prostate cancer, its diagnosis andthe various treatment options available, including High IntensityFocused Ultrasound (HIFU) ablation. It will help you understand whyyour urologist has recommended this particular approach.

Introduction

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The prostate is a part of the malereproductive system.

The prostate is not involved in sex-ual intercourse directly. Its functionis to adds nutrients and fluid tosperm.

Normally the size of a walnut, theprostate tends to grow with age. Itis located in front of the rectumand just below the bladder. It sur-rounds the urethra, the tube thatcarries urine and semen throughthe penis.

Scrotum

Bladder

Urethra

Penis

Testicle

SeminalVesicle

Rectum

Prostate

Anus

The prostate

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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 into surrounding tissue.

Typically malignant cells will growand multiply forming a mass of tis-sue known as a tumor. First located in one organ, a tumor maygrow into surrounding tissue andalso spread throughout the body.

When tumor cells are transportedthrough the blood and lymph systems to reach remote organs,we use the term metastases (fromthe Greek word meaning displace-ment).

Prostate cancer is the most common cancer in men; responsi-ble for one in three of all male cancers. There are more cases ofprostate cancer every year thanlung and colon cancer.

The aggressiveness of prostate can-cer can vary; some cancers devel-op very slowly and have no symp-toms, whereas others spreadquickly, invading surrounding tissue and forming metastases.

The risk of prostate cancer increaseswith age. Prostate cancer is diag-nosed in about 1 of every 7 menduring their lifetime but only 1 in 38will die of the disease. There aregenerally no signs or symptoms dur-ing the early stages of the disease,and these appear depending onwhere the cancer is located in theprostate and whether it has spread.

What is cancer?

Prostate Cancer

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

Prostate cancer can be detected inroutine screening. A doctor willperform a digital rectal examination of the prostate to feelfor any abnormalities such ashardness or increased size. A doc-tor may 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 of cancer. The PSA test helps identifytumors that cannot be detected bydigital rectal examination (about

30% of cases of all prostate cancers). Some cancers are detect-ed during treatment of benignprostate hypertrophy. Tests to check for cancer include:

1. BiopsyA sample of prostate tissue isremoved with a fine needle forexamination.

2. MRI or CT scanImaging of all body organs todetect for possible cancer in thelymph nodes, liver or other organs.

3. Bone scanImaging of all bones to check forany cancer in the bones.

Assessment & diagnosis

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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 and

the surrounding lymph nodes.Surgery requires a general anes-thesia and lasts about three to fourhours.

External radiotherapyThis treatment involves the use ofradiation (very high energy rays)directed at the prostate gland to

Cancers are diagnosed at differentstages of development and pro-gression and are classified into:

� Localized prostate cancer(stages T1 or T2).

The tumor is confined to the prostate itself (intracapsular).

Stage T1

Only a few cells haveturned cancerous andso cancer can only be

detected via blood tests or a biop-sy. The cancer is not revealed by arectal examination.

Stage T2The cancer is a littlebigger and makes theprostate gland harder.

A doctor can now detect the can-cer during a rectal examination.

� Locally advanced prostate cancer (stages T3 and T4)

The tumor spreads into surround-ing organs

Stage T3

The prostate cancerhas spread to the shellof the prostate gland.

Stage T4The prostate cancerhas spread outside theprostate and possiblyto other organs.

Classification

Treatments for localizedprostate cancer

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� High Intensity FocusedUltrasound

High Intensity Focused Ultrasound(HIFU) is a minimally-invasive ablation which can be used forcases of localized (contained)prostate cancer. Ultrasound wavesare focused with extreme preci-sion instantly and effectivelydestroying the targeted cells with-in the prostate.The ultrasound waves are deliveredvia a probe which is inserted intothe rectum. The procedure lastsone to three hours and can be per-formed under general or spinalanesthesia.

� About Ablatherm HIFU

Ablatherm HIFU is a minimally-invasive medical device whichuses HIFU (High IntensityFocused Ultrasound) to ablateprostate tissue.

The procedure requires only ashort hospital stay and has a low complication rate. The prostate tis-sue will be destroyed by the ther-mal effect of HIFU (temperaturerising to 85°C), therefore there isno radiation involved.

� Who should undergo HIFU?

Your urologist may recommendAblatherm HIFU if you require treat-ment for localized prostate cancer forthe first time and wait a minimallyinvasive treatment.

kill cancerous cells. Most healthycells have a special repair mecha-nism if affected by this type ofradiation but cancer cells do notso are killed. Radiotherapy doesnot require anesthesia and treat-ment is generally given during reg-ular visits over several weeks.

BrachytherapyThis treatment is performed undergeneral anesthesia most of the

time and involves the implantationof tiny radioactive seeds directlyinto the prostate gland to irradiateand destroy the cancer cells.

CryotherapyGuided by ultrasound, the prostategland is frozen solid killing the cancerous cells. The procedure isdone under general or spinal anes-thesia.

About Ablatherm® HIFUprocedure

� Are there reasons why or circumstances in which HIFUprocedure is not a possibleoption?

Almost none – this type of proce-dure is not the most appropriatefor men with very large prostatesbut if is the case a TURP(Transurethral Resection of theProstate) or hormone treatmentcan be given to reduce the size ofthe gland so that the AblathermHIFU procedure is made possible.In some cases Ablatherm HIFU isnot recommended for men whohave experienced hardening of therectal wall due to previous cancertreatments.

� Is HIFU FDA approved?

The first treatment was performedin 1993 and the latest generationof Ablatherm HIFU device wasgiven market approval for Europe(CE) in 2005 and for the USA(FDA) in 2015.

As of 2015, over 45,000 patientshave benefited from AblathermHIFU in 250 centers across theworld.

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� How does Ablatherm HIFUwork?

The doctor uses the AblathermHIFU device to ablate prostate tis-sue. The doctor inserts a probeinto the rectum. This probeincludes an imaging componentwhich allows the doctor to viewthe treatment area on a computerscreen. The probe also includes atransducer which emits thefocused ultrasound waves.

The doctor inputs a treatment planinto the computer which then con-trols and aims the ultrasoundwaves. These are focused withextreme precision onto the targetedcancerous cells in the prostate,causing a very brief rise in temper-ature (around 85° C). The targetedtissue is then instantly and effec-tively destroyed, while the sur-rounding tissue is preserved.

The Ablatherm HIFU machinehas numerous safety checks whichare constantly monitored through-out the procedure to ensurepatient safety. This means that thetreatment is always delivered to thesame high standard and quality.

� Procedure

You will be asked to come intohospital the night before yourtreatment. You will be given adigestive preparation (enema) toprepare the rectum. The procedureis generally performed under local(epidural) or general anesthesia toensure you remain completelystill. You will lie on your right-hand side and the doctor willplace a gel-coated probe into yourrectum. The doctor locates yourprostate and the area to be treated.The HIFU procedure can thenstart - 400 to 600 shots of HighIntensity Focused Ultrasound

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

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waves are generally given. Theprocedure can last between oneand three 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.

To reduce the need for catheteri-zation after treatment, atransurethral resection of theprostate (TURP) can be performedbefore the procedure. TURPinvolves removing the part of theprostate which presses on the ure-thra by passing a thin tube up theurethra via the penis.

� Is the Ablatherm HIFUprocedure painful?

The procedure itself is not painfulas it is carried out under spinalanesthetic (epidural) or general

anesthetic. Pain at the end of thetreatment is rare, although mostpatients feel a slight discomfortwhich disappears after a few days.The procedure is minimally inva-sive so there are no wounds andpatients do not experience theburning sensation often associatedwith radiotherapy.

� What happens after treatment?

Most patients can go back to eatingnormal food the evening after treat-ment and are discharged from hos-pital the next day. The urinarycatheter is generally removed threeor four days later. Medication maybe prescribed after HIF prevent anyinfection of the urethra or bladder.In the period after treatment youmay experience some discomfortincluding mild bleeding at the startof urination, frequent and some-times urgent urination, urine leak-age during physical exertion orcoughing and sometimes the elimi-nation of dead cancer cells in theurine. Infections with fever are rarebut possible and require antibiotics.These side effects disappear in theweeks following the treatment.

� What long-term follow up isrequired?

Usually PSA levels are checkedevery three months and a biopsy isundertaken six months after treatment.

The Ablatherm HIFU probe is controlled bya computer to generate the ultrasound waves.

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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 accessiblefor ultrasound ablation.

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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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The benefits

The ablation of prostate tissue with High Intensity Focused Ultrasound isan option with many advantages:

� Non-invasive procedure

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

� Does not use radiation

� Can be performed under spinal anesthesia

� Can be performed in one session

� Requires only a short stay in hospital

� Other therapeutic alternatives can be considered if results areunsatisfactory