SCIONTI PROSTATE CENTER, LLC
SARASOTA, FLORIDA

Prostate cancer is the most common cancer in men with over 230,000 men diagnosed in the US yearly. However, the prostate cancer world is undergoing a revolution. There is a newfound understanding that the disease has been over-treated in many men. The “gold standard” for treating prostate cancer has always been radical or robotic surgery.  Studies have now documented the long-term functional side effects (erectile dysfunction and incontinence) associated with traditional treatments like surgery and radiation. The survival advantages of traditional treatments have been shown to be small or non-existent. In fact, The US Health Preventive Task Force panel has declared that PSA screening for the early diagnosis of prostate cancer has no net benefit and that the “harms outweigh the benefits. It’s clear that a new approach is necessary that helps to identify men that will benefit from treatment as well as prescribe treatments that are less invasive and cause fewer side effects. Our approach at the Scionti Prostate Center recognizes this changing prostate cancer landscape and employs new biomarkers, advanced MRI imaging, Artemis MRI guided fusion mapped biopsy and genomic tumor testing to better characterize and classify prostate cancer to determine which men will benefit from treatment. Our treatment approaches emphasize targeted MRI guided techniques such as focal robotic HIFU using information learned from our advanced diagnostic evaluation. Our goal is to find a better balance between prostate cancer treatment and quality of life related side effects such as erectile dysfunction and incontinence. The Scionti Prostate Center Leads The Way With  Scionti MMM HIFU Treatment The Scionti Prostate Center provides your personalized pathway to prostate cancer care. When HIFU is appropriate, the Scionti MMM (Triple M) HIFU treatment is the most advanced HIFU treatment in the world engineered to provide better ablation with less side effects. The Gastroenterology and Urology Device Panel of the FDA met on July 30, 2014 and made a negative recommendation on the EDAP Ablatherm Integrated Imaging High Intensity Ultrasound PMA submission. It is important to recognize that this Panel was tasked with making recommendations to the FDA regarding the safety, efficacy and the risk/benefits ratio of the EDAP Ablatherm Integrated Imaging High Intensity Ultrasound device. It was not a review of HIFU technology in general. EDAP was not able to present adequate data to support the endpoints defined in their submission. The original trial was proposed as a non-randomized comparison of HIFU to cryotherapy in the target population with a two-year follow up period. EDAP was unable to enroll patients in the cryotherapy arm and failed to enroll the required number of patients in the HIFU arm. Instead, EDAP presented multiple data sets, which were determined by the Panel to be non-equivalent. As a result, their submission was considered to be insufficient by the Panel to make a favorable determination. Several studies have been published on HIFU effectiveness with both the Sonablate device and the Ablatherm device. Please see the TREATMENT section for a discussion of these results. It is the opinion of the Scionti Prostate Center that is well selected patients, HIFU is a clinically effective treatment option for men with localized prostate cancer that better preserves urinary and sexual function. The urethra consists of different anatomical segments. From the tip of the penis to the base of the bladder: the fossa navicularis (or meatal opening), the pendulous urethra, the membranous urethra and the prostatic urethra. During total gland HIFU, the entire prostate is destroyed, including the prostatic urethra, as it can have cancerous cells in it. In doing so, the end result is an empty cavity that acts like a conduit during normal urination. However, the urethra is derived from a different type of tissue (derived from the bladder squamous type epithelium) vs. prostatic tissue (glandular, fibrotic and muscular) and regenerates or re-epithelializes with time. The external sphincter and bladder neck are the vital structures with respect to maintenance of urinary function, NOT the urethra. These vital structures are not affected or harmed during HIFU. In the case of a focal HIFU treatment, the urethra is PRESERVED. The Scionti Prostate Center  Dr. Scionti has worked extensively with high intensity focused ultrasound (HIFU) and with over 800 successful procedures is considered one of world’s most experienced HIFU surgeons. He has collaborated with leading medical treatment centers around the world to help perfect HIFU technology, research medical applications, and train urologists to perform HIFU. Additionally, Dr. Scionti is leading the effort to train American urologists in this therapy and serves as Medical Director for Vituro Health. Currently,  Dr. Scionti is an experienced cryosurgeon and has performed over 1,000 prostate procedures. In addition to his clinical practice, Dr. Scionti, helps teach and proctor urologists on prostate Cryotherapy techniques. He actively researches and lectures on Cryotherapy technology and clinical outcomes. Formerly, Dr. Scionti was the Medical Director and Founder of the Hilton Head, SC International Center for Men’s Health. He is a leading contributor to the COLD Registry, a national database of cryotherapy outcomes. He also organized the National Cryotherapy Trianing Workshop and helped train more than 200 urologists annually on the use of the Cryotherapy to treat prostate cancer. Founder and Director of the Scionti Prostate Center  Dr. Scionti has worked extensively with high intensity focused ultrasound (HIFU) and with over 1000 successful procedures is considered one of world’s most experienced HIFU surgeons. He has collaborated with leading medical treatment centers around the world to help perfect HIFU technology, research medical applications, and train urologists to perform HIFU. Additionally, Dr. Scionti is leading the effort to train American urologists in this therapy and served as Director of Clinical Education and Training for USHIFU prior to FDA approval of HIFU. Currently, Dr. Scionti uses HIFU to treat prostate cancer patients at the Vituro Health HIFU Center in Sarasota, Florida and serves as the Medical Director of Vituro Health.