HIFU Scientific Trial:
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 Cry therapy 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 Scientific TRial 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.