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High Intensity Focused Ultrasound (HIFU) - A guide

Prostate cancer has dramatically increased in the past few years. In Germany, 28,000 new cases of prostate cancer are diagnosed each year. The reason for this increase can be found, on the one hand, in the higher life expectancies and, on the other, in the markedly improved early detection of prostate cancer. The quality of the diagnosis has improved markedly as a result of regular prophylactic examinations, checking for the PSA prostate marker (prostate-specific antigen), improved diagnosis by means of PCR, PCa 3 and elastography, and last but not least by means of radiological diagnostic methods such as magnetic resonance imaging and computer tomography. The cancer has already metastasized in 10 to 20 % of the patients who are diagnosed for the first time (in other words, the cancer has already affected other organs). The problem for the physicians is that they currently cannot prognosticate just how dangerous the cancer is for the patient.
By classifying the type of tissue, an attempt is made to find out exactly how malignant the tumor is. The Gleason Score is therefore a useful procedure that can be used to make statements regarding the malignancy of a tumor. The Gleason grading system ranges from zero to 10, with patterns of decreasing differentiation, i.e., the malignancy of the tumor.

Diagnosing prostate cancer

A diagnosis is generally made based on an elevated PSA level, suspicious prostate findings, an unusual ultrasound finding and, finally, a biopsy that confirms the finding. Recently, it has become possible to diagnose prostate cancer rather accurately without a biopsy by examining the protein profile in the urine (DiaPat), identifying PSA positive cells in the blood and specification through diagnostic apheresis, and last but not least through MRI imaging as well as determining the choline and citrate level.
The decisive factor here is that the patient undergoes regular prophylactic examinations, since prostate cancer does not cause any problems/pain in its early stages. Once prostate cancer is causing massive problems/pain for the patient, it is usually a delayed symptom. It is therefore important to discover the prostate cancer in as early a stage as possible. Depending on the extent, the stages are classified from T1 to T4.

 

The diagnosis has been made - now what?

Mostly baffled, the patient is faced with a large selection of therapy options. In many cases it is not clear whether the diagnosed cancer is so malignant that a radical therapy is indicated.

Range of conventional therapies

MEASURE RISK
Radical prostatectomy Impotence; almost always incontinence up to 10%; generally stressful surgical procedure with following risks: bleeding, infection.
Irradiation Radiation damage to neighboring organs (bladder, large intestine); then surgery due to fibrotization is possible only with increased risk.

Brachytherapy

(Implantation of radioactive particles)

Undesired radiation damage: invasive, damage to the tissue; then surgery due to fibrotization is possible only with increased risk.
Cryotherapy / cryo application Undesired radiation damage: invasive, damage to the tissue; then surgery due to fibrotization is possible only with increased risk.
Hyperthermia Too unspecific.
 

Therapy with medication:

Hormone ablation (Zoladex, Profact, etc.)
Intermittent androgen receptor blockade, if possible in combination with Bicalutamid (Casodex)
Intermittent androgen receptor blockade
Triple therapy (Leibowitz): hormone ablation, finasteride and flutamide
Prostasol
These procedures involve some significant risks and negatively affect the patient's quality of life (impotence, risk of incontinence, personality changes when hormones are given, etc.).

Solution: HIFU therapy

HIFU stands for high intensity focused ultrasound. In HIFU therapy, a bundled sonic field is focused on diseased tissue in the prostate. Due to the significant energy deposition at the focus, temperature within the tissue rises to 95° to 100° C, destroying the malignant tissue in the tumor (heat coagulation). As a result of the exact, computer-controlled definition of the treatment field it is possible to treat the entire prostate volume, if need be all the way to the organ borders.
It is therefore possible to treat the prostate cancer in a touchless manner from the large intestine without any cutting, without opening the abdominal cavity or intruding on the body's integrity.
As a result, quality of life will only be slightly limited, in particular as the therapy only requires the shortest of inpatient stays. Essentially, there are no fundamental limitations, except that a permanent catheter must be worn for approximately ten days. If the therapy has been carried out in a professional manner no particular side effects are to be expected. In our patient histories (HIFU users since 1994, approximately 950 patients) we have observed neither incontinence nor injuries to the neighboring organs (e.g. rectal fistulas). In some cases, asymmetric scarring can cause a constriction or closure of the bladder opening, which generally can be remedied by a small laser procedure.
PSA levels of under 2.0 µg/l, negative PCR and DiaPat and, if required, a negative biopsy confirm the success of the therapy.
The HIFU procedure can be repeated. A radical prostatectomy can be carried out even afterwards; however, this might be made more difficult by periprostatic scar formation. Radiation treatment after HIFU can be carried out; on the other hand, patients who have undergone radiation treatment can also be treated with HIFU.

The image shows, schematically, the burning lens effect of the transducer head. The tissue that the rays transverse hardly warms up; the malignant tissue is only thermally coagulated in the focal point.

Which patients are suited for treatment?

+ Localized prostate cancer without any metastatic spreading
+ PSA under 10 µg/l
+ Tumor stage T1 to T2, no more than T3
+ Prostate size below 40 g (if required, pre-treatment with hormones to decrease size)

Preparation

No eating the evening before the procedure and emptying the intestines with the help of an enema. No food on the day of the treatment, neither liquids nor solids.

How the HIFU treatment is carried out

Depending on the size of the prostate, the time required for treatment is between two and three hours. Combination anesthesia guarantees that the patient experiences no pain. It is adapted to the individual and includes local anesthesia and a mild general anesthesia.
Due to the development of intense heat during the treatment the prostate gland swells for a longer period of time, which is why it is generally necessary to insert a permanent transurethral catheter. We expect that the swelling will go down after 8 to 10 days with the right medication.

After treatment

The patient will undergo a follow-up examination one day after the treatment, then after one month and then every three months. The success of the therapy is examined by determining the PSA level, by using transrectal ultrasound and, if needed, by a biopsy of the prostate and by means of radiological procedures.
Some patients complain only of a feeling of pressure in the lower abdominal area/the intestines. In general, this can be alleviated with specific medication.

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