Wednesday, November 19, 2014



Stephen Leslie, Omaha, NE, Ronald Wheeler*, Gerald Grubbs, Brian Wheeler, Herman Fernandez, Sarasota, FL, Aleah Bond,
Omaha, NE

INTRODUCTION AND OBJECTIVES: High Intensity Focused Ultrasound (HIFU) therapy offers significant theoretical advantages over conventional definitive treatments for localized prostate cancer with fewer side effects and reduced cost. Efficacy of HIFU, however, remains in question. The purpose of this study is to assess the outcomes of our modified HIFU patient selection protocol utilizing Multi-Parametric MRI (MP-MRI) imaging and PSA cutoff levels for the identification and improved management of localized prostate cancer patients treated with HIFU therapy.

METHODS: Retrospective 85 month pilot study of prospectively collected data on 67 HIFU patients previously identified with biopsy proven localized prostate cancer. Inclusion criteria: 1) localized lesions based on MP-MRI. 2) PSA levels ≤ 8.5 ng/ml. Outcome parameters: 1) Biochemical Disease Free Rate. 2) Need for definitive salvage therapy.

RESULTS: 67 men with biopsy proven prostate cancer (low, intermediate and high grade) and a PSA ≤ 8.5 ng/ml underwent MP-MRI imaging which confirmed localized disease. Patients were subsequently treated with definitive whole gland HIFU therapy. There were 36 patients with Gleason 6 (PSA range 0.3–8.5), 28 patients with Gleason 7 (PSA range 1.67–8.5), 2 patients with Gleason 8 (PSA range 4.6-6.3) and 1 patient with Gleason 9 (PSA of 8.1). Mean PSA prior to treatment in all groups: 5.2. Mean PSA nadir (post treatment) in all groups: 0.14 ng/ml.

Complications: Urethral narrowing or bladder neck contractures occurred in about 20% of patients but were easily treatable. No incontinence, rectal wall injury, fistulas or ED was noted long term. Mean follow-up: 27.3 months (range: 3–85 months). Biochemical Disease Free Rate was 99%. Patients needing definitive salvage therapy: 1 patient.

CONCLUSIONS: Early results of this pilot study reveal that patient selection criteria using a PSA cutoff of 8.5 ng/ml and confirmed localized disease on MP-MRI imaging, significantly improves the Biochemical Disease Free Rate and substantially reduces
the need for definitive salvage treatment following definitive HIFU therapy for prostate cancer. This data warrants further study.

Source of Funding: None

Tuesday, August 13, 2013

95% Cure Rate for Prostate Cancer In Men Treated With HIFU (High Intensity Focused Ultrasound)

SARASOTA, Fla., March 5, 2013 /PRNewswire/ -- The Sarasota, Florida based Diagnostic Center for Disease™ in conjunction with PanAm HIFU, LLC, released data today showing a 95% cure rate with HIFU (High Intensity Focused Ultrasound) in more than 200 patients at more than 7 years post treatment. This group of patients had biopsy proven prostate cancer in conjunction with a 3.0 Tesla Magnetic Resonance Imaging Spectroscopy scan (MRI-S).  Ronald E. Wheeler, M.D. (Medical Director) attributes the results to excellence in imaging, excellence in application of technology as well as excellence in patient selection. While MRI-S continues to be evaluated in a head to head comparison to random prostate biopsies, it appears the MRI-S scan is the missing piece of the diagnostic puzzle allowing for a dramatic improvement in treatment results. Approximately 700,000 American men receive a negative prostate biopsy result; however approximately 25% of these results are false-negative. Under the current standard of care, prostate biopsy procedures collect 10-12 needle biopsy cores on average, effectively sampling less than 1% of a man's prostate. This approach leaves men at risk for a hidden cancer, leading to a high rate of repeat biopsies, often on cancer-free men, which hinders or delays the application of a procedure with this high rate of cure.

Specifically, the MRI-S scan allows for an enhancement of various diagnostic discrimination factors including: evidence of extracapsular extension (ECE), dominance of cancer in a side to side assessment, true density of tissue based on a diffusion weighted image sequence (DWI), dynamic contrast enhancement (DCE) and spectroscopy (if assessable). Once the patient assessment has taken place, a qualified HIFU treating expert can expect to experience predictably better results than those achieved without the MRI-S scan. Dr. Wheeler goes on to say that current worldwide data with HIFU (regardless of technology utilized) supports a cure rate of approximately 78-80%. Our data is a seminal study that enables prostate cancer patients the opportunity to improve their choice of one therapy versus another.


PanAm HIFU Comments:
This press release speaks to the importance of patient selection prior to the HIFU treatment decision.  HIFU is not a one-size-fits-all treatment; patients must be appropriate candidates for HIFU.  Pre-treatment evaluation including Multi-Parametric MRI, is Dr. Wheeler’s preferred approach to patient selection. Through his experience treating patients with HIFU for more than 7 years, Dr. Wheeler strives to continually advance his techniques; the result – a high rate of success.