Courtesy of Focused Ultrasound Foundation: See Article Here
Dr. Stephen Scionti is a board-certified urologist who specializes in prostate cancer treatment. He founded and opened Scionti Prostate Center in 2014, just before the US Food & Drug Administration (FDA) approved two high-intensity focused ultrasound (HIFU) devices: SonaCare Medical’s Sonablate and EDAP’s Ablatherm. Beyond HIFU, Dr. Scionti offers a full range of diagnostic services, including MRI fusion targeted prostate biopsy and, most recently, treatment with Profound Medical's transurethral ultrasound ablation (TULSA-PRO) device, which was approved in the US in 2019.
Dr. Scionti is also able to introduce these technologies to other urologists as the Medical Director for Vituro Health, a teaching and training network for physicians.
Prior to moving to Florida, Dr. Scionti served as Clinical Associate Professor of Urology and Director of Prostate Cancer Ablative Surgery at New York University School of Medicine and Langone Medical Center’s Joel E. Smilow Comprehensive Prostate Cancer Center. He previously had founded the Hilton Head, SC, International Center for Men’s Health.
How did you become interested in HIFU?
I started my urology career offering prostatectomy and radiation (brachytherapy). I was an early adopter of cryotherapy in the late 1990s, but it is imprecise, and the energy is difficult to control. In 2005, I was introduced to HIFU and immediately understood how it could solve the limitations of cryotherapy.
Because of my interest in HIFU, I became the Director of Clinical Education and Training for SonaCare Medical. In this role, I spent two to three weekends per month over a period of 10 years traveling to the Caribbean to treat patients. I became licensed in Bermuda, the Bahamas, and the Cayman Islands. We treated American patients as a part of the British medical system. It was a long journey, but it allowed me to provide feedback for improving the software, the provider’s ease of use, and the level of patient care for the Sonablate device. These clinical trials also allowed us to standardize the technology. We knew that we had an impressive device, and we worked to develop processes for how best to use it and for which patients.
I was the lead proctor for SonaCare’s radiation-recurrent clinical trial and trained the Principal Investigators at each treatment site. Our goal was to safely complete the treatments while using a complex technology in a high-risk population (the patients who had failed radiation treatment). These safety and efficacy data led to the 2015 FDA approval for treating prostate tissue.
It’s exciting to see the technology evolve. Now we are repeating the same treatment refinement processes with the TULSA-PRO system. During clinical trials, the company’s engineers ensure that each case goes perfectly. Commercialization is different, because that level of support is not there. That is why Vituro Health is beneficial. It helps physicians introduce the community to the technology. It also brings facilities up to speed with things like anesthesia and training the nursing and technical staff. It takes six to eight months of significant work to get new providers to the stage that they can confidently treat patients. We share lessons learned so that the startup process is not so cumbersome.
Besides prostate cancer, do you treat other conditions at Scionti Prostate Center?
I am a prostate disease specialist and offer treatment for prostate enlargement, which is also called benign prostatic hyperplasia (BPH).
Which treatment system(s) does your facility use for patient care?
We have a SonaCare Sonablate system at our local specialty hospital, Lakewood Ranch Medical Center. The Sonablate system is my workhorse prostate ablation technology. I recently started to use Profound Medical’s Transurethral TULSA-PRO system. I have also used EDAP’s Ablatherm system but do not currently use it.
Which prostate system do you use for each type of pathology?*
We are learning which approach is best for each patient based on prostate size and tumor location. Treating the prostate with ultrasound ablation allows for a full or partial prostate gland treatment, depending on tumor size and prostate gland size.
I have the most experience using Sonablate, and it is the right choice for a large number of patients. It will also likely achieve reimbursement sooner than TULSA-PRO.
A larger prostate with BPH is an indication for using the TULSA-PRO system, and tumors that are located in the anterior part of the prostate are better matched to TULSA-PRO because its inside-out approach allows for more energy deposition (because the distance is shorter from the urethra). The farther the energy has to travel, the more energy is lost. TULSA-PRO also has an advantage for patients who have a normal size prostate but need total gland ablation. It is a one-step, one-procedure, process under the administration of one anesthetic.
Describe your individualized approach to patient selection.
I encourage my patients to be directly involved in making all treatment decisions. In my practice, it is a joint decision between the physician and patient. I find that men with prostate disease generally fall into four categories:
- Patients younger than 65 who have early detection (and therefore a smaller treatment volume) are usually interested in a focal approach to treatment. These men make up 60% of our practice, and the goal is to preserve function with a subtotal ablation. The types of ablation are hemi, true focal, focal with margin, or multiple focal lesions.
- Older men that have clinically significant cancer are not candidates for active surveillance. These patients are usually in their 70s, and they may have coexistent BPH. If possible, we prefer to offer them a radiation-free ablative approach. HIFU or TULSA-PRO allows us to treat both conditions.
- Some men are borderline for active surveillance. For example, a 75-year-old man in excellent health with either a high-volume Gleason Grade 6 or a low-volume Gleason Grade 7 prostate cancer could be monitored with active surveillance but is not ideal for surveillance. The only other standard approaches are treatments such as radiation therapy or radical prostatectomy. There has been nothing the middle. There is an important need for “middle ground” treatments that don’t require aggressive therapy.
- According to the National Comprehensive Cancer network, a patient with a Gleason Grade 6 small volume tumor is very low risk, and these men are encouraged to pursue active surveillance.
How is your prostate cancer diagnosis process unique?
There is no substitute for an accurate diagnosis! Because of the range of disease outlined above, we take a comprehensive approach with a suite of advanced technology to locate and characterize each area of cancer, assess its risk, and provide a personalized pathway to care. Our diagnostic process incorporates four of the latest technologies: Biomarkers, 3T Multiparametric MR Imaging with 3D Prostate Mapping, Artemis Fusion-Guided Targeted Biopsy and 3D Tumor Mapping, and genomics. Read more about these techniques on Dr. Scionti’s website.
How many patients are you treating at your clinic?
We have a high-volume program. Before the arrival of the COVID-19 pandemic, I averaged 20 to 25 patients per month with the Sonablate HIFU system. In 2019, I performed more than 200 prostate HIFU procedures in Florida.
Over the first three months that it was installed, I used the TULSA-PRO system for 17 procedures. The TULSA-PRO program is growing, as I treated seven of those patients in March. There is a lot of interest from patients interested in new ultrasound ablative treatments. Fortunately, the state of Florida has resumed elective procedures, and I expect to remain busy treating our prostate cancer patients.
Why is ultrasound therapy important to your patients?
It provides noninvasive treatment options with minimal side effects. It allows for personalized treatment that is right for each individual. Every man places the risk-benefit balance on their own life situation. It’s not the doctor’s job to make that decision. I believe in educating patients about the guidelines, as well as alternatives, and letting them decide. This is precision medicine, and it gives the power to the patient. A personalized and customized treatment plan is superior to a cookie-cutter approach.
Tell us about your office and clinical staff.
The patient care team at Scionti Prostate Center is focused on providing specialized care to prostate cancer patients. Our patient support team is led by Ann Jakubosky RN, BSN. Ann, an experienced prostate cancer nurse, guides our patients through the pretreatment preparation process, post treatment recovery, and long-term prostate cancer monitoring. Patients who contact our center to inquire about HIFU or TULSA-PRO treatment are greeted by Michelle Rayner, who has more than five years of experience working with our patients. Michelle provides general information about our prostate cancer treatments and assists patients with gathering their medical records for review. Aubrey Robertson, our Medical Concierge, schedules and facilitates appointments at the Scionti Prostate Center and is the main point of contact at our center. The entire staff is committed to serving our patients professionally with expertise and compassion.
Do you track outcomes in a data bank?
We maintain an internal data registry, and we also use SonaCare’s HEAT registry. We have a full-time nurse and staff that help with data collection and entry.
Insurers want data that are generated in the US and published in peer-reviewed journals. Most journals want data from a large number of patients who have been followed for more than five years. We have now collected four years of data on 700 patients in the US with good follow up.
Have you presented your patient data at medical meetings?
I was pleased to present my results on using HIFU to treat radiation-recurrent prostate cancer at the February 2020 FOCAL therapy symposium in Washington, DC. I was disappointed that the American Urological Association (AUA) Annual Meeting was cancelled this month because a lot of excitement was building for the ultrasound technologies, and we had a large user group scheduled to attend. Urologists are interested in the technology, and these are the physicians who have been caring for prostate cancer patients over the long term. If we do not work hard to train our colleagues, other specialties will be interested in treating our patients but not necessarily following them over the course of their lifetime. We need to take the lead in our specialty with proper education and training. AUA is creating a new virtual training experience, and we hope to use that platform.
Who coordinates your patient care and how do patients reach that person?
Inquiries to the Scionti Prostate Center can be initiated online by filling out the consultation request form on our website (www.sciontiprostatecenter.com), by calling us at 866-866-8967, or by email to: email@example.com.
How do you attract patients to your practice? Do you have a system for direct patient outreach or marketing? Do you have outreach to referring physicians?
While many of our patients are referred by former patients, their friends, or their families, our website is a major source of patient inquires. Patients will find us as they search for alternatives to traditional prostate cancer treatment or if they simply search for HIFU treatment specialists. We have a network of referring physicians from across the country who are inspired by the experiences of their patients who we have cared for.
Have you been successful with obtaining treatment reimbursement for your patients? What are the challenges?
Medicare does not currently provide total universal reimbursement for prostate HIFU. Although many patients currently pay out of pocket and are on their own for obtaining coverage, Vituro Health offers our patients assistance with trying to obtain reimbursement for their procedures. Patients who request treatment preauthorization from private insurance companies hear “no” as a stock answer. Our team at Vituro Health will assist patients with an appeal of the insurance company’s decision after their procedure and provide the insurance company with published studies. I have had many discussions with medical directors of the insurance plans. The results are not uniform, but we are seeing some successes. In Florida, we have a Medicare facility code for HIFU, and our Medicare contractor has been reliable in reimbursing the hospital for this facility fee. We have done hundreds of procedures in the hospital setting with the reimbursed C code, but this is not uniform across the US.
Why are you such a passionate advocate for HIFU and ultrasound therapy for prostate cancer patients?
I strongly believe that there must be a treatment alternative beyond the standards of radiation therapy or radical prostatectomy. Someone has to take a leadership position to develop it because so many patients do better with less invasive treatment. It is still early in the process. I would like to help urologists understand that we need more options and I believe that ultrasound ablation will play a role in providing alternative options for patients.
Using a less-invasive technique up front does not limit the ability to add other treatments in the future. Prostate cancer can recur after surgery, radiation, or HIFU too. The most difficult patient in my practices is a patient that has had primary radiation therapy and then has a high Gleason recurrent cancer. Those patients have few options and are difficult to treat with the disease still advancing. I believe that it is better to start with a personalized, less-invasive approach. Starting with ultrasound therapy provides a better balance of treatment and side effects, and it leaves more options open in the future. Taking the most aggressive approach is not personalized care.