Results of HIFU for Newly Diagnosed Prostate Cancer
Summary of HIFU Compared to Radical Surgery and Radiation
Randomized clinical trials are the best way to compare various treatments. The ProtecT Trial published in New England Journal of Medicine 2016, showed efficacy of radiation and surgery are similar. Incontinence from surgery was 20%. Erectile Dysfunction was 80% with surgery and 66% with radiation.
Whole Gland HIFU has an incidence of Erectile Dysfunction that is 56% lower compared to radiation and 65% lower compared to surgery. HIFU also has a 3% incidence of incontinence which is similar to no treatment or Active Surveillance. This compares to surgery which has a 20% incidence of incontinence.
Donovan et al N Engl J Med. 2016 Oct 13;375(15):1425-1437; Sponsor Executive Summary PMA P13003 (www.fda.gov)
HEMI HIFU or Focal Treatment of
The concept of treating only the cancerous part of an organ is standard for all cancers except prostate until recently. Dr. Perinchery Narayan along with Dr. Gary Onik did the first procedure of “male lumpectomy” using cryotherapy in 2002. At that time HIFU was not available for use in the US. Since then many investigators have duplicated Dr. Narayan’s results.
Comparison of Side effects of Focal/Hemi HIFU vs Surgery and Radiation
Compared to surgery and radiation Hemi HIFU has an incontinence and erectile dysfunction rate which is the same as no treatment. It has been found that even with no treatment, patients have a small incidence of incontinence and impotence due to aging. Surgery causes 20% incontinence and 80% impotence. Radiation causes 66% impotence.
Other complications of surgery include a 20% short-term complication rate within 30 days which includes complications such as cardiac events (5.5%), respiratory events (11%), rectal injury (0.3-3.8%), blood transfusion (0-31%), mortality (0.5%), and vascular or bleeding complications (2.7-4.7%)
Michaelson et al. 2008 MGH, Multicenter Review.
Radiation also is associated with GI toxicity (2.3-16%) and GU toxicity (10-29%)
Vora et al. 2013 Mayo Clinic; Zietman et al. 2010 MGH, Multicenter Review.
Partial or Hemi HIFU treatment has the same side effect profile as no treatment or Active Surveillance Patients are spared any side effects but yet do not have the uncertainty of monitoring cancer that may grow. Partial treatment of the prostate is only possible with HIFU. No other therapy provides precise treatment with millimeter accuracy and safety.