What is HIFU? HIFU stands for High Intensity Focused Ultrasound. It delivers high frequency sound waves which creates heat to specific areas of the prostate to kill the cancer cells. A trans-rectal probe is inserted into your rectum to reach the prostate and more accurately target the prostate cancer with the strong beams.
This is a newer treatment for prostate cancer which in the past has shown a lack of efficacy. The US FDA studied and made a recommendation about HIFU. They recommended that HIFU should not be approved for routine use in men with low-risk prostate cancer due to unclear effectiveness.
Researchers looked at 227 men with low-risk disease. Some of them received a TURP procedure, while others received androgen-deprivation therapy, or a combination of these treatments. This actually made the analysis or comparison with other therapies more challenging.
The researchers found that the overall effectiveness of HIFU was unclear. Biochemical recurrence was used as an outcome, which the FDA does not qualify as a valid outcome. They consider either metastasis or overall survival, and there were very limited data regarding either of those. And because only 94 men out of the 227 men were studied for more than 8 years, the analysis was based on a small number of patients.
In regards to the complications and side effects, there were many. Urinary retention occurred in 1%-20%; UTI occurred in 2%-48%; Incontinence occurred in 1%-34%; ED occurred in 20%-82%. Overall, the efficacy was very low and the side effect rates were high; this difficult to accept. Another issue was that 15% of the patients were re-treated within one year and 34% had salvage therapy, which was often a repeat procedure. After 8 years, the failure rate or the need to re-treat was about 40%.
While many people have been excited about HIFU give that about 40,000 men worldwide have been treated with it in the past 15 years, the data and efficacy have yet to prove as highly successful as other treatments for prostate cancer.