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Excellence in High Intensity Focused Ultrasound (HIFU) Outcomes
Date:11/12/2013

ovan reported on 402 patients treated between 2005 and 2010. 100% of Dr. Orovan's patients received biopsy confirmation while no patients were identified as having had an MRI (Magnetic Resonance Imaging) scan prior to the HIFU procedure.  Dr. Wheeler's outcome data is noted in a study of 147 patients who qualified by virtue of preselected study criteria associated with a PSA value of ≤ 8.5 ng/ml, a Gleason Score of ≤ 8 (4+4) with subsequent treatment within 4 years of diagnosis. All patients in Dr. Wheeler's research had been diagnosed with either a biopsy or an MRI scan or both. Specifically, 70 patients had a confirmational biopsy (either proceeded by a scan or followed by a scan), while 77 patients were diagnosed by MRI (+ or – Spectroscopy) alone.

Results – Dr. Orovan qualified his group in accordance with the D'Amico stratification criteria as low and intermediate risk. Of 402 patients treated and followed to 4 years, 183 (45.5%) were low risk and 219 (54.5%) were intermediate risk. For clarity purpose, a low grade cancer in Dr. Orovan's treatment group was a Gleason score 6 (3+3) while the intermediate group comprised a Gleason score 7 (3+4, 4+3). Depending on which classification for success was utilized Dr. Orovan's data reflected a cure rate of 76% for the Gleason 6 cancers while his cure rate was 69.5% for the Gleason grades of 7 (3+4, 4+3). Cure was defined by biochemical stability of the nadir (= .36 ng/ml) reached while failure was defined when a PSA value that reached the nadir and then rose to some point consistent with failure as defined by the Stuttgart or Horowitz definition. In Dr. Wheeler's data 147 patients received HIFU and followed for up to 6 years. In his data using a nadir (˂ .30 ng/ml) all but one patient succeeded with a cure rate of 99%. Specifically, the biopsy group (N= 70) noted the following characteristics: 37 patients had a Gleason scor
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