FocalyxTM conceived as a response to emerging evidence data across numerous cancer lesions that questions current standard treatment approaches that too often lead to detrimental quality of life yet delivering limited survival benefit, especially in-lieu of advances in imaging technology applicable to cancer patients. The Focalyx paradigm aims to control cancer with improvement in quality of life. We initially devised 5 milestones: 1- Consistently optimize Prostate MRI imaging using the novel published protocols adopted as guidelines by societies such as the European Society of Urology and Radiology; 2- Evaluate fusion platform software solutions that existed; 3- Determine best fusión platform for Focalyx on practicality, precision, and workflow premises; 4- Evaluate commercially available FDA approved ablative technologies to implement our treatment vision; 5- Design a treatment option that can be performed in the office setting under local anesthesia, which would not impact negatively QOL outcomes of Prostate Cancer patients and seamless constant nonintrusive practical patient-physician interaction by the Focalyx app that facilitates follow up and provides early warning signals shall any change in the disease dynamics emerge. Prostate cancer was identified as the pilot disease for Focalyx to deliver a "GPS" like solution for the prostate gland that destroys identifiable disease without adverse effects such as: cancer anxiety, urinary incontinence, loss of erections and ejaculation. Since September of 2013, over 300 men have been accrued in NCT02381990- clintrials.gov evaluating the feasibility of our solutions for imaging (FocalyxDx), Biopsy (FocalyxBx) and Treatment (FocalyxTx). In this review we detail the tools available to achieve the Focalyx paradigm for men with Prostate Cancer.
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Archivos espanoles de urologia. 2016 Jul [Epub]
F J Bianco, J I Martínez-Salamanca
Urological Research Network. Professor of Urology. Nova University. Miami. EE.UU., Hospital Universitario Puerta de Hierro. Universidad Autónoma de Madrid. Madrid. Spain.