Randy AuCoin (Exact Imaging) Prostate cancer is the most common cancer in Europe for males. In 2012, around 417,000 new cases of prostate cancer were diagnosed in Europe, and approximately 92,300 deaths were attributed to prostate cancer (1). The costs associated with detection and treatment of this disease is very significant to health care systems throughout Europe.
Current standard of care
Prostate cancer is diagnosed by a pathologist analysing tissue samples taken from a man’s prostate via ultrasound-guided biopsy. When a man is determined to have elevated risk factors or symptoms commonly associated with prostate cancer, a urologist orders a prostate biopsy procedure. During this routine procedure, between 10 and 14 separate tissue samples are collected and subsequently sent to pathology for analysis. Ultrasound is the standard of care worldwide for guiding prostate biopsies. Using a transrectal ultrasound probe, the prostate is imaged and the operator guides the biopsy needle to the various locations he or she would like to collect the tissue samples from.
Unfortunately, the resolution on conventional ultrasound systems used for prostate biopsy procedures is inadequate to distinguish between cancerous tissue and benign tissue. As a result, prostate biopsies are collected systematically, simply following a needle placement and spacing protocol with the hope of hitting the cancer if it is present. This “blind biopsy” approach results in a 30%-40% false negative rate (missed cancer). During a recent section meeting for urological imaging (2) organized by the European Association of Urology (EAU), distinguished speaker Dr. Hashim Ahmed from University College London referred to the current standard for performing prostate biopsies as “rubbish.”
In an attempt to overcome the lack of adequate resolution on conventional ultrasound systems, some larger institutions throughout Europe and North America have been experimenting with adding MRI into the workflow for guiding prostate biopsies. This does not eliminate the need for the ultrasound-guided prostate biopsy procedure; rather it adds on a process called MRI/Ultrasound “fusion” whereby suspicious areas identified on MRI can be targeted with the hopes of missing fewer serious prostate cancers.
There is a growing body of evidence that if an institution can successfully modify its workflow to add on an MRI procedure and can develop the expertise necessary to master the fusion approach, improved clinical outcomes can be obtained for the patient. Published clinical studies seem to be demonstrating that there are some improvements in clinical outcomes when the MRI/US fusion workflow is implemented properly and the required techniques mastered. However, an active debate continues regarding the practicality of implementing this approach given the significant increase in total procedure cost, the steep learning curve to get improved results, the considerable change to the standard clinical workflow, and the increased procedure time, just to name a few of the issues. With significant downward cost pressure on healthcare systems worldwide, experts question the practicality of implementing such techniques that dramatically change clinical workflow and significantly increase overall procedure cost.
Solution: Using much better ultrasound
The lack of resolution on conventional ultrasound systems is the root-cause of the problem of not being able to visualise and distinguish suspicious tissue so that those areas can be “targeted” for biopsy. Exact Imaging has developed a high resolution micro-ultrasound system for urology that addresses the problem of inadequate ultrasound resolution. This micro-ultrasound system was originally commercialised for small animal imaging in the field of pre-clinical research, in which researchers study human disease models in mice and require much higher resolution due to the small structures they are imaging. This proven technology is the gold-standard for small animal ultrasound imaging with over 2,000 systems installed worldwide. Exact Imaging has adapted this revolutionary technology and taken it from mouse to man.
The ExactVu™ micro-ultrasound system offers a 300% increase in resolution and this allows for targeted prostate biopsies to be performed without requiring the add-on of MRI. A 2,000 patient randomized-controlled clinical trial is currently underway at five sites across North America. The trial should conclude in May 2016 and is expected to demonstrate that improved clinical outcomes are possible in an “ultrasound-only” prostate biopsy setting. Approval to market the ExactVu™ micro-ultrasound system in Europe is expected in June 2016.
A solution to a clinical problem is only a solution if the healthcare system can afford to implement it. Cost-effectiveness has several components including appropriate patient care, physician expertise required, availability of necessary imaging equipment, procedure cost, and procedure time. Conventional ultrasound is the standard of care for guiding prostate biopsies. It meets all measures of cost-effectiveness with only one exception: it has inadequate resolution. ExactVu™ solves the problem by providing targeted prostate biopsy capability in a cost effective manner within existing clinical work flow. The adoption of this technology will be an important step for dealing with Europe’s high incidence and prevalence of prostate cancer
The article is authored by Randy AuCoin, President and CEO, Exact Imaging.
1. Cancer Research UK, accessed at www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/prostatecancer
2. ESUI 2015 (November 12, 2015: Barcelona)