HIFU Clinical Trials

HIFU, or High Intensity Focused Ultrasound, is a newer prostate cancer treatment that serves as an alternative to surgery or radiation. HIFU has been available in Europe for over a decade, and in Canada since 2003. The first North American clinic opened in Toronto in 2005. The procedure is currently being evaluated by the FDA and is not yet available in the United States. The clinical data and research shows 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 a number of well respected universities and treatment centers across Europe. Of those, 402 were treated using HIFU, High Intensity Focused Ultrasound as the first choice therapy. The remainder received Cryotherapy or EBRT, External Beam Radiation Therapy.

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

Of the 402 patients treated first with HIFU, 87.2% showed negative biopsies on tests conducted for 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 the patients were T1 or T2 and all received HIFU as the first choice treatment.

When PSA levels were tested 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 spiked immediately following a HIFU treatment. When a second treatment was done, another rise in levels was observed but with lower peaks than the first. PSA levels were monitored for several months afterward and found to have dropped to normal levels and stabilized. Tissue biopsies showed no return of the cancer in 87.2% of the patients.

Negative Side Effects

Complications in patients after HIFU treatment were found to be consistent across Europe where these studies were carried out. Also consistent were the affirmations from patients treated that their quality of life was unchanged before and after treatment.

Side effects noted were as follows.

  • 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%
  • Blockages to the urethra, 8%
  • Mild to moderate urinary incontinence, 5%
  • Total urinary incontinence, <1%

There were no reported deaths due to HIFU. Impotent patients responded well to treatment with erectile dysfunction. All in all, there were fewer significant side effects with HIFU than other forms of treatment, including radiation and surgery.

Conclusions

HIFU clinical trials proved it to be a valid alternative treatment for patients not eligible for or who do not wish, or are unable, to undergo a surgical prostatectomy or radiation.

Another important finding was noted. Of the patients whose cancer inhabited half the prostate gland or less, biopsies were negative for up to 51 months after treatment.

More recent trials with over 400 patients were recently conducted in Canada at the Maple Leaf HIFU Clinic from 2003 – 2011. Results were similar showing that HIFU is a safe and effective treatment with fewer significant side effects for men with organ confined prostate cancer.



Source by Stephanie Browning



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