YANA - YOU ARE NOT ALONE NOW
PROSTATE CANCER SUPPORT SITE
EFFICACY AND SIDE EFFECTS OF
HIFU(HIGH INTENSITY FOCUSSED ULTRASOUND)
The National Institute for Clinical Excellence in Britain is examining high-intensity focused ultrasound for prostate cancer and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about high-intensity focused ultrasound for prostate cancer. This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation and can be accessed here.
This extract from the document summarises the views of the Advisory Committee on the Efficacy and Safety of the procedure:
EFFICACY
The evidence was based on case series and the main outcomes reported were
negative biopsy rates and PSA nadir levels. Some studies reported disease-free
survival rates but the criteria used to define disease varied. A systematic
review, including eight case series, reported a negative biopsy rate of 60%
(37/62) in one study with follow-up not specified, and 80% (75/94) in a study
with 3-year follow-up. In three further studies in the review, the proportion
of patients without clinical or biochemical evidence of disease ranged from
56% (28/50) at 24 months to 66% (67/102) at 19 months.
Three additional case series reported negative biopsy rates between 87% (251/288)
in a study with mean follow-up of 13 months and 93% (128/137) in a study with
mean follow-up of 22.5 months. One of these studies, which included 146 patients,
also reported disease-free survival rates of 54% or 71.5%, depending on the
criteria used to define disease-free status.
The
Specialist Advisors considered that long-term data
are needed to establish whether the procedure reduces prostate cancer specific
mortality.
SAFETY
Urinary tract infections and stress incontinence were the most commonly reported
complications, affecting between 4% (6/137) and 48% (46/96) and between 8%
(9/111) and 23% (23/102) of patients in two case series. Rectourethral fistula
was reported in between less than 1% (1/137) and 3% (3/111) of patients. Four
studies reported rates of impotence after the procedure between 24% (75/315)
and 100%
(62/62) but the proportion of men who were potent before treatment was inadequately
reported. Other complications included prolonged urinary retention, urge incontinence,
urgency, bladder neck stenosis, urethral stenosis, urethritis, prostatic abscess,
epididymitis, asymptomatic rectal burns and chronic pelvic pain.
The Specialist Advisors listed urinary incontinence, rectal fistula, bowel
perforation and erectile dysfunction as potential adverse events but noted
that this procedure appears to be safer than alternative radical treatments
for prostate cancer. Two Specialist Advisors noted that there were
concerns regarding control of local heating and limiting sound energy to the
target area.
In
recommending that further research and audit should address long term survival,
the committee noted that prostate cancer patients frequently die from unrelated
causes
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