**10. Complications and side effects of HIFU treatment**

HIFU is a minimally invasive treatment for prostate cancer, thus resulting in a low complication rate.

Sometimes, minor complications can occour, in the vast majority of cases related to lower urinary tract.

The first one is urinary retention, commonly treated with longer catheterism. The most common is urge incontinence, due to the irritative effect of high-focused ultrasound on the bladder neck. Generally, it disappears in a couple of month, and only in rare cases anticolinergic treatment is required.

Lower urinary tract symptoms, such as frequency, nocturia, weak urinary stream, and so on, are prevented by Trans-Urethral Resection of Prostate (TUR-P), that is recommended to be done 6-8 weeks before HIFU treatment. Anyway, the surgeon is advised to administrate IPSS questionnaire (or equivalent) before the treatment end 3 months after the treatment, in order to assess persistent lower urinary tract symptoms, that should be treated pharmacologically or surgically, if needed.

Infection is another possible complication of this treatment. Antibiotic prophylaxis should prevent this complication, if administrated in accordance with guidelines on infection prevention.

Among the major complications, the most important is recto-vesical or recto-urethral fistula. Only few cases are reported in literature. This complication can be initially treated with longer catheterization, but in some cases surgical repair is required. A common tip to avoid this complication is to safely set the target area on the ultrasound screen, as the slight wall of the rectum can easily lead to fistulization. Also, patients previously diagnosed with ulcerative recto-colitis must not be treated with high-intensity focused ultrasound.

The most important side-effect of HIFU treatment is erectile disfunction and impotency, due to the effect of high intensity ultrasound on the neural bundle. This effect is well known and must be discussed with the patient before the treatment.

Color-doppler-combined technique is reported in literature in order to perform a sort of vessel-sparing procedure, thus resulting in a better outcome by the andrological point of view. However, there is not common agreement among the investigators about the effectiveness and the feasibility of this technique. For this reason, it cannot be recommended at the present time (Fig. 10).

The best management of the patient should include IIEF questionnaire (or equivalent) to be giver before the treatment and 6 months after the treatment in order to assess the sexual outcome.

Patients who are keen on having sexual activity should receive a proper treatment.

High-Intensity Focused Ultrasound (HIFU)

area of the treated volume.

a re-treatment if required.

72-63% and 68-62%.

**12. References** 

available in the next years.

Prostate 1990;17:337-47

1999; 161: 156-62.

condition that excludes the transrectal approach.

selected area and to save all the tissues around it.

lesions until all prostate tissue is destroyed;

the striated sphincter) and vasculo-nervous bundles.

within 6 months after the treatment in all patients.

morbidity and preservation of continence and erectile function.

[2] European Association of Urology. Guidelines 2011 Edition.

the outcome. *Eur Urol* 2001; 40: 124-9

As reported in literature, HIFU demonstrated a good oncologic outcome.

beam that destroys local tissues through three mechanisms:


An absolute contraindication to the procedure is every rectal anatomic or pathologic

The technology of the device used to perform the treatment allows to exactly destroy a pre-

Conceptually, a piezoelectric trasducer generates a high intensity converging ultrasound

1. *coagulative necrosis*, due to hyperthermia (85-100°C) generated in the focal point. Elementary lesion is ellipsoidal and the short length of the shot limits heat diffusion around the focal point. Shot by shot, it is possible to generate a plethora of elementary

3. *heat growth*, maximal in the middle of the treated volume and minimal in the external

This difference allows to surely set the treatment outlines and save the prostate apex (and

HIFU is a minimally invasive ablative technology for managing localized prostate cancer in both the primary and salvage setting. It is a single-session procedure with the possibility of

The advantage of this technique are short hospital stay, reduced convalescence, low

The PSA nadir is a major predictive factor for HUFU success and it is generally reached

The most recent results are reported in a study carried out by Crouzet et al. In this multicentric study the mean PSA nadir was 1.0±2.8 ng/mL with a median of 0.25 ng/mL. The 5-year and 7-year Disease Free Survival Rate (DFSR) for low, intermediate-, and highrisk patients (according to D'Amico risk stratification criteria) were, respectively, 83-75%,

As expected by most investigators, the development of more sophisticated technologies should improve these results and lead to a widespread use of this technique. Focal treatment or doppler-combined devices for nerve- or vessel- sparing procedures will be

[1] Steinberg GD, Carter BS, Beaty TH, et al. Family history and the risk of prostate cancer.

[3] Gelet A, Chapelon JY, Bouvier R, Pangaud C, Lasne Y. Local control of prostate cancer

[4] Gelet A, Chapelon JY, Bouvier R, Rouviere O, Lyonnet D, Dubernard JM. Transrectal

[5] Rebillard X, Gelet A, Davin JL, et al. Transrectal high intensity focused ultrasound in the treatment of localized prostate cancer. *Journal of Endourology* 2005, 19, 6:693-701.

by transrectal high intensity focused ultrasound therapy: preliminary results. *J Urol* 

high intensity focused ultrasound of localized prostate cancer: factos influencing

2. *cavitation*, due to the gas microbubble vibration dissolved in prostate tissue;

not affected by tumor (red line).

Fig. 10. Color-doppler device for HIFU treatment. Thanks to this additional equipment, it is possible to perform a highly selective treatment (blu line). This can preserve vascular bundle or a portion of prostate

### **11. Summary**

At the time of diagnosis, prostate cancer is organ-confined in 70% of the cases.

The choice of the appropriate treatment for localized prostate cancer is one of the most controversial issues in urologic oncology. Approximately, the most majority of these patients undergo local therapy: surgery or external beam radiation. The rest of the remaining patients do not fit this treatment and are scheduled for Androgen Depriving Therapy (ADT) or watchful waiting.

Besides these treatments, other mini-invasive procedures have emerged in the last few years, such as Brachytherapy, Cryosurgical Ablation, Radiofrequency Interstitial Tumour Ablation and High-Intensity Focused Ultrasound (HIFU).

HIFU represents an alternative choice in mini-invasive treatment of prostate cancer. The treatment is performed under regional anaesthesia and is generally preceeded by limited Trans-Urethral Resection of Prostate (TUR-P).

It is a transrectal procedure: after introducing the rectal probe, anatomic limits must be echographically set (apex, bladder neck, rectal side, prostate capsule), in order to make the computer able to determine the correct subdivision in different prostate portions (generally four).

Fig. 10. Color-doppler device for HIFU treatment. Thanks to this additional equipment, it is possible to perform a highly selective treatment (blu line). This can preserve vascular bundle

The choice of the appropriate treatment for localized prostate cancer is one of the most controversial issues in urologic oncology. Approximately, the most majority of these patients undergo local therapy: surgery or external beam radiation. The rest of the remaining patients do not fit this treatment and are scheduled for Androgen Depriving

Besides these treatments, other mini-invasive procedures have emerged in the last few years, such as Brachytherapy, Cryosurgical Ablation, Radiofrequency Interstitial Tumour

HIFU represents an alternative choice in mini-invasive treatment of prostate cancer. The treatment is performed under regional anaesthesia and is generally preceeded by limited

It is a transrectal procedure: after introducing the rectal probe, anatomic limits must be echographically set (apex, bladder neck, rectal side, prostate capsule), in order to make the computer able to determine the correct subdivision in different prostate portions (generally four).

At the time of diagnosis, prostate cancer is organ-confined in 70% of the cases.

not affected by tumor (red line).

Therapy (ADT) or watchful waiting.

Ablation and High-Intensity Focused Ultrasound (HIFU).

Trans-Urethral Resection of Prostate (TUR-P).

or a portion of prostate

**11. Summary** 

An absolute contraindication to the procedure is every rectal anatomic or pathologic condition that excludes the transrectal approach.

The technology of the device used to perform the treatment allows to exactly destroy a preselected area and to save all the tissues around it.

Conceptually, a piezoelectric trasducer generates a high intensity converging ultrasound beam that destroys local tissues through three mechanisms:


This difference allows to surely set the treatment outlines and save the prostate apex (and the striated sphincter) and vasculo-nervous bundles.

HIFU is a minimally invasive ablative technology for managing localized prostate cancer in both the primary and salvage setting. It is a single-session procedure with the possibility of a re-treatment if required.

The advantage of this technique are short hospital stay, reduced convalescence, low morbidity and preservation of continence and erectile function.

As reported in literature, HIFU demonstrated a good oncologic outcome.

The PSA nadir is a major predictive factor for HUFU success and it is generally reached within 6 months after the treatment in all patients.

The most recent results are reported in a study carried out by Crouzet et al. In this multicentric study the mean PSA nadir was 1.0±2.8 ng/mL with a median of 0.25 ng/mL. The 5-year and 7-year Disease Free Survival Rate (DFSR) for low, intermediate-, and highrisk patients (according to D'Amico risk stratification criteria) were, respectively, 83-75%, 72-63% and 68-62%.

As expected by most investigators, the development of more sophisticated technologies should improve these results and lead to a widespread use of this technique. Focal treatment or doppler-combined devices for nerve- or vessel- sparing procedures will be available in the next years.
