Saturday, April 13, 2019

HIFU clinical trial

HIFU or high-intensity focused ultrasound is a relatively new treatment for prostate cancer that can be used as an alternative to surgery or radiation therapy. Since 2003, HIFU has been listed in Europe for more than a decade and is listed in Canada. In 2005, the first North American clinic opened in Toronto. The program is currently being evaluated by the FDA and is not currently available in the US. Clinical data and studies have shown that HIFU is a safe and effective treatment for men with organ-limited prostate cancer.

European research

In a clinical study that began in 1995, 559 prostate cancer patients were studied in many respected universities and treatment centers in Europe. Among them, 402 cases were treated with HIFU, and high-intensity focused ultrasound was the preferred therapy. Remind to receive cold therapy or EBRT, external beam radiation therapy.

All patients studied were T1 or T2, which means their cancer was confined to the prostate.

Of the 402 patients who were first treated with HIFU, 87.2% showed a negative biopsy in trials up to 51 months after treatment - meaning that the treatment effectively destroyed cancer.

Another study conducted at the University of Regensburg, Germany, from 1997 to 2002 focused on 146 patients with prostate cancer. Similarly, all patients were T1 or T2, and all patients received HIFU as the preferred treatment.

When the PSA levels were tested 3 months after treatment, they were found to be higher. When tested after 22 months, 87% showed a significant improvement and 93.4% showed a negative biopsy of the tissue samples.

Research observation

The study found that PSA levels initially spiked immediately after HIFU treatment. When the second treatment was performed, another level of increase was observed but the peak was lower than the first time. PSA levels were monitored for several months and found to have fallen to normal levels and stabilized. Tissue biopsy showed that 87.2% of patients had no cancer recurrence.

Negative impact

In Europe conducting these studies, it was found that the complications of patients after HIFU treatment were consistent. The patients from the treatment are certainly consistent, that is, their quality of life has not changed before and after treatment.

The side effects noted are as follows.

  • Sexual impotence of cancer found in areas where nerves enter the prostate, 66%
  • No sexual impotence of cancer found in the area where the nerve enters the prostate, 20%
  • Urethral obstruction, 8%
  • Mild to moderate urinary incontinence, 5%
  • Total urinary incontinence, <1%

HIFU did not report the number of deaths. Patients with impotence respond well to treatment of erectile dysfunction. In summary, HIFU has fewer significant side effects than other forms of treatment, including radiation and surgery.

in conclusion

HIFU clinical trials have proven to be an effective alternative to patients who are unqualified or undesired or unable to undergo surgical prostatectomy or radiation therapy.

Notice another important finding. In patients attributable to cancer of half or less of the prostate, the biopsy was negative for up to 51 months after treatment.

More than 400 patients from 2003 to 2011 were recently tested at the Maple Leaf HIFU clinic in Canada. The results are similar, indicating that HIFU is a safe and effective treatment with fewer side effects in patients with organ-limited prostate cancer.





Orignal From: HIFU clinical trial

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