Focal Therapy of Prostate Cancer

Nicolai Hübner; Shahrokh F. Shariat; Mesut Remzi


Curr Opin Urol. 2018;28(6):550-554. 

In This Article

High-intensity Focussed Ultrasound

HIFU has been used as whole-gland treatment for a long time, in Europe, and received FDA-approval for ablation of prostate tissue in 2015. Effects of HIFU on human prostate tissue have already been described in 1995[8] when patients received HIFU prior to radical prostatectomy to analyse tissue changes. It was originally developed as a minimally invasive alternative to radical prostatectomy, as a whole-gland treatment for men with localized PCa. Early results were promising for primary and salvage therapy,[9–12] yet large prospective trials comparing HIFU to radical prostatectomy or radiation therapy are missing.

For focal therapy, HIFU is one of the most promising methods being tested. Known side effects such as rectal fistula, which have been known to occur after whole-gland therapy (1.2–2.2%),[10,13] are less common with the focal approach (0–1%), the improvements to the devices and safety precautions, such as rectal cooling.[14,15]

In a data analysis by Albisinni et al.,[16] seven datasets for focal and hemi-ablation of unilateral PCa were pooled and reported. Three hundred and sixty-six patients were included in this analysis with a median follow-up of 2.2 years. Negative biopsy rate during follow-up was 77% (66–87%) and salvage treatment-free survival (radical prostatectomy, radiation therapy, ADT) was 92% (85–98%). With follow-up being so short, conclusions concerning oncologic outcome are premature at this point. Functional outcomes showed a very low rate of incontinence with continence being defined as pad-free continence in five out of the seven studies included. Even with this very strict definition, continence at 12 months was very high at 96% (91–100%). A potency-rate of 74% (64–84%) at 12 months was also calculated, yet the definitions used in the different studies varied greatly.

The same group also published their matched-pair analysis, comparing 55 patients who underwent hemi-ablation with HIFU to 55 patients undergoing robotic radical prostatectomy.[17] Within a median follow-up of 36 months, there was no statistically significant difference in salvage therapy, yet patients undergoing HIFU showed a significantly lower rate of de-novo erectile dysfunction (20 vs. 44%, P = 0.03) as well as higher continence rates at 1 month (82 vs. 40%, P = 0.001).

Ganzer et al.[18] reported the findings of their Phase II clinical trial including 51 patients who underwent hemi-ablation. Follow-up was again short with a mean of 17.4 months. Biopsy at 12 months was positive in 26.5% of patients, with 8.2% showing significant cancer. Ten patients (19.6%) underwent salvage therapy. Of the 30 men being potent preoperatively, 21 maintained potency. Impact of focal therapy on anxiety, depression and quality of life (QoL) was also reported. There were no significant changes in the QoL score used, as well as the anxiety score, which were both normal during the entire follow-up. Yet, the HADS-D (Hospital anxiety and depression scale), used for depression, increased significantly during follow-up from 8.8 at baseline to 10.7 at 3 months (P = 0.022). The median then declined during further follow-up, yet remained at 10.1 at 12 months. This is the first study reporting anxiety and depression, which, as one rational behind the use of focal therapy is the reduction of anxiety and depression in some active surveillance patients, shows the need for further investigation of the subject. This also indicates that focal therpy should not be used to reduce anxiety under active Surveillence.

As one of the more frequently used modalities, there is constant optimization of the devices, and some new machines have the option of an in-bore procedure with a transurethral probe and MRI real-time imaging, and heat monitoring. Publications on these new devices will follow soon.