HIFU Clinical Trials

 HIFU, or High Intensity Focused Ultrasound, is a newer treatment for prostate cancer that serves as an alternative to surgery or radiation. HIFU has been available in Europe for more than a decade and in Canada since 2003. The first North American clinic opened in Toronto in 2005. The procedure is currently under evaluation by the FDA and is not yet available in the United States. Clinical data and research show that HIFU is a safe and effective treatment for men with organ-confined prostate cancer.


Research in Europe


In a clinical research study that began in 1995, 559 prostate cancer patients were studied by several well-respected universities and treatment centers throughout Europe. Of these, 402 were treated with HIFU, High Intensity Focused Ultrasound as the first choice therapy. The rest received cryotherapy or EBRT, external beam radiation therapy.


All of the patients studied were stage T1 or stage T2, meaning their cancers were confined to their prostate glands.


Of the 402 patients first treated with HIFU, 87.2% had negative biopsies in tests performed up to 51 months after their treatments, meaning the treatment was effective in destroying the cancer.


Another study conducted at the University of Regensburg in Germany between 1997 and 2002 focused on 146 prostate cancer patients. Again, all patients were T1 or T2 and all received HIFU as first-line treatment.


When PSA levels were assessed 3 months after treatment, they were found to be higher. When tested after 22 months, 87% showed great improvement and 93.4% showed negative biopsies on tissue samples.


Study Observations


The study found that PSA levels initially rose immediately after HIFU treatment. When a second treatment was performed, another increase in levels was observed but with lower peaks than the first. PSA levels were monitored for several months afterward and were found to have dropped to normal levels and stabilized. Tissue biopsies showed no return of cancer in 87.2% of patients.


negative side effects


Complications in patients after HIFU treatment were found to be consistent across Europe where these studies were conducted. Reports from treated patients that their quality of life was unchanged before and after treatment were also consistent.


The side effects observed were the following.


Sexual impotence where cancer was found in the region where the nerve enters the prostate gland, 66%

Sexual impotence where no cancer was found in the region where the nerve enters the prostate gland, 20%

Obstructions in the urethra, 8%

Mild to moderate urinary incontinence, 5%

Total urinary incontinence, <1%

No deaths from HIFU were reported. Impotent patients responded well to treatment with erectile dysfunction. In general, there were fewer significant side effects with HIFU Treatment than with other forms of treatment, including radiation and surgery.


Conclusions


Clinical trials of HIFU have shown it to be a valid alternative treatment for patients who are ineligible for or unwilling or unable to undergo surgical prostatectomy or radiation.


Another important finding was observed. Of the patients whose cancer occupied half of the prostate or less, biopsies were negative up to 51 months after treatment.


More recent trials with more than 400 patients were recently conducted in Canada at the Maple Leaf HIFU Clinic between 2003 and 2011. The results were similar and showed that HIFU is a safe and effective treatment with fewer significant side effects for men with prostate cancer. confined to the organ.

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