Topic: NGLC-HIFU

Cancer Control in 1379 Men Undergoing HIFU: A Multi-institute 15-year Experience

by Mark Emberton, MD, FRCS | Apr 2022

Mark Emberton, MD, FRCS, Professor of Interventional Oncology at University College London, summarizes the design and findings of a 15-year multi-institute study of high-intensity focused ultrasound (HIFU) in patients with nonmetastatic prostate cancer. After an introduction from E. David Crawford, MD, Professor of Urology at the University of California, San Diego, and Editor-in-Chief of Grand Rounds in Urology, Dr. Emberton notes that the results of this 15-year study resulted in a wave of positive press about HIFU in popular outlets, observing that this widespread enthusiasm is due not just to HIFU’s efficacy, but its safety and adverse event profile as well. He then details the design of the study, beginning with the patient profile. Noting that outcomes in prostate cancer treatment are largely dependent on the risk profile of the patient, Dr. Emberton explains that in this study the average patient age was 66, ⅕ of patients had a PSA greater than 10, the average prostate volume was relatively low, the majority of patients were Gleason 3+4, and the majority of patients were T2. He mentions that intervention varied, and that while the majority of patients had quadrant ablation, about ⅓ had hemiablation. Dr. Emberton then considers the outcomes, observing that the “headline” of the study was the 83% 5-year failure-free survival for intermediate-risk disease. He also highlights that only 0.5% of patients experienced greater than 2 adverse events. Dr. Emberton discusses some supplementary data, emphasizing that if a clinician commits to HIFU, they also commit to retreating a subset of patients. He concludes that HIFU is very safe and that the data suggests that the majority of eligible patients with intermediate-risk disease can defer or avoid radical therapy with HIFU.

High Intensity Focused Ultrasound for Prostate Cancer: Guidelines, Complications, and Outcomes

by Arvin George, MD | Sep 2021

Arvin George, MD, Assistant Professor of Urology at the University of Michigan in Midland, Michigan, reviews high intensity ultrasound (HIFU) for prostate cancer and outlines guidelines, patient selection, complications, and outcomes for the treatment. The NCCN guidelines state that HIFU is included as a salvage option after prior treatment failure, specifically radiation failure, but is not recommended as routine primary therapy due to lack of long-term comparative data. The EAU guidelines say to only offer HIFU within clinical trials or well-designed prospective cohorts. Dr. George describes the ideal HIFU patient as having unifocal, clinically-significant, and MRI-visible disease that has an absence of high-risk features. He then goes over a list of common complications and their rates of occurrence: retention (7-27%), hematoma (0-1.6%), sloughing (3-8%), urinary tract infection (5-18%), orchitis (2-8%), abscess (1-2%), fistula (.3-3%), pain (.5-3%), erectile dysfunction (12-30%), incontinence (0-5%), and stricture (2-4%). Dr. George says that to prevent complications one should not retreat the posterior zone, and should plan above the capsule while avoiding near field heat. He then reviews a study on focal therapy compared to radical prostatectomy for non-metastatic prostate cancer that found mostly HIFU focal therapy to have a failure free survival (FFS) rate comparable to that of radical prostatectomy, never exceeding a difference of 13%. Dr. George also discusses another study of medium-term oncological outcomes in a large cohort of men treated with either focal or hemi-ablation using high-intensity focused ultrasonography for primary localized prostate cancer which showed FFS rates of 86% at 24 months, 64% at 60 months, and 54% at 96 months. He concludes with a final study which consolidated and compared HIFU’s outcomes to those of active monitoring, radiotherapy, and radical prostatectomy, showing that HIFU produces consistently better quality of life outcomes.

Management of Recurrent Prostate Cancer After Focal Therapy

by Kelly L. Stratton, MD | May 2021

Kelly L. Stratton, MD, Assistant Professor of Urologic Oncology in the University of Oklahoma (OU) Department of Urology in Oklahoma City rationalizes the implementation of Focal Therapy despite chances of recurrence and discusses salvage therapy. He characterizes Focal Therapy as an option between radical treatment and active surveillance, which preserves quality of life. The perfect candidate is hard to achieve, according to Dr. Stratton, due to the rarity of a patient with intermediate-risk cancer, lesion localization, intact erections, and minimal urinary tract symptoms; however, he states that the ideal candidate doesn’t have to be perfect. Dr. Stratton overviews the two main types of recurrence: in-field recurrence and contralateral recurrence, through patient examples, which display how recurrence may occur post Focal Therapy and the abilities of high intensity focused ultrasound, prostatectomy, and cryoablation as salvage therapies. A multicentre study of five year outcomes post Focal Therapy found a failure free survival rate of 88% with 25% of patients having had undergone retreatment, data that Dr. Stratton states to suggest a need for providers to openly discuss the chances of repeat focal therapy against having a more aggressive treatment. He reviews data that supports implementation of Focal Therapy and displays the impact of different salvage therapies. Dr. Stratton concludes by stating that Focal Therapy’s success requires adherence to the principles of active surveillance, follow-up biopsies, and a willingness to provide definitive local therapy when focal treatment fails.

Focal Therapy Compared to Radical Prostatectomy

by David Utz | May 2021

Steven N. Gange, MD, FACS, Director of Research and Education at Granger Medical Clinic/Summit Urology Group, reviews a propensity score-matched study comparing focal therapy (FT) for localized prostate cancer to radical prostatectomy (RP). Dr. Gange explains that, until now, this information has never been reported, as randomized controlled trials (RCTs) comparing RP to FT methods such as high-intensity focused ultrasound (HIFU), brachytherapy, or cryotherapy have historically failed to enroll and could be considered unethical given the disparity of risk. By using propensity score matching, the researchers for this study roughly simulated an RCT by selecting patients with matching entry criteria from a diverse dataset, ultimately testing 246 patients on each respective side. The primary outcome was failure-free survival, and Dr. Gange notes that at 3, 5, and 8 years the results were similar for both cohorts. Each cohort also had similar biochemical and histopathological outcomes. Dr. Gange concludes that this appears to be a reasonable comparison between RP and FT, but observes that there are some limitations to the study, including an inability to account for confounding variables and to adjust for baseline urinary and sexual function, as well as a lack of long-term outcomes.

HIFU Bill Coding 2021

by Mark N. Painter, CPMA, MBS | Apr 2021

Mark N. Painter, CPMA, managing partner of PRS Consulting LLC, the CEO of PRS Urology Service Corporation, the Vice President of Coding and Reimbursement Information for Physician Reimbursement Systems, Inc., and CEO of Relative Value Studies, Inc., discusses changes to Medicare billing in 2021, covering HIFU (high intensity-focused ultrasound) and detailing how the procedure is reimbursed. He details how the new CPT code for 2021, code 55880, is used for ablation of malignant prostate tissue, transretally approached, using high intensity-focused ultrasound (HIFU) and ultrasound guidance. Mr. Painter details how Medicare has set up facility payments: HIFU can only be billed once per date of service, and many Medicare carriers still consider HIFU as a non-covered service. Also, if the HIFU is done at a non-participating facility, it becomes patient responsibility. The new code does not allow for co-surgeons or assistant surgeons. He points out that there is an established fee schedule for facilities and appropriate values for the code, and advises to look at coverage rules and to keep an eye on individual carriers to see whether they will follow NGS moving forward or not. Mr. Painter also advises to check with each payer before providing this service to find where coverage is, where patient responsibilities lie, and to juggle that with your charges and reimbursement activity.

Case Study on HIFU for Prostate Cancer

by Vahan Kassabian, MD | Apr 2021

Vahan Kassabian, MD, Director of the Atlanta Prostate Center and Advanced Therapeutics at the Advanced Urology Institute of Georgia, presents a case study to illustrate the benefits of treating certain prostate cancer patients using high-intensity focused ultrasound (HIFU) instead of radical prostatectomy and radiation therapy. He begins by reviewing the circumstances of the patient’s diseases in 2015, then summarizes treatment and followup from early 2016 through January 2021. Finally, he explains how HIFU has been beneficial for the patient so far and what options are available at this point in their still-evolving journey.

Hemi-gland HIFU Ablation: Initial Outcomes From 100 Cases

by Samuel Peretsman, MD | Feb 2021

Samuel J. Peretsman, MD, a urological oncologist with Urology Specialists of the Carolinas in Charlotte, North Carolina, discusses the results and the implications of two recent American studies of high-intensity focused ultrasound (HIFU) for treating prostate cancer. In the first part of the presentation, Dr. Peretsman reviews the initial outcomes of a study on HIFU of hemigland ablation for prostate cancer. He explains that reports of focal HIFU performed in the United States have been lacking, and therefore this study aimed to report the initial and largest American series of HIFU prostate gland ablation as a primary treatment for prostate cancer. Dr. Peretsman discusses the methodology, limitations, and results of the study, concluding that short-term results of focal HIFU indicate safety, excellent potency and continence preservation, and adequate short-term prostate cancer control. In the second part of the presentation, Dr. Peretsman outlines the lessons learned from a study of salvage robotic prostatectomy following whole-gland HIFU. Based on the data on patients with HIFU-persistent disease, Dr. Peretsman argues that there is room for improvement in HIFU treatment follow-up in order to optimize the results of salvage therapies. He also concludes that more assurance of successful salvage therapy may boost patient confidence in HIFU as a primary therapy choice.

HIFU Focal Therapy: Prostate Cancer – Emerging Data and Clinical Utility vs. Standard Care

by Andre Abreu, MD | Jan 2021

Andre Abreu, MD, Urologist at the Keck Hospital of University of Southern California, describes how high-intensity focused ultrasound (HIFU) works, and the data that earned it FDA-approval for prostatic tissue ablation in November 2015. Following this, Dr. Abreu reviews the three main goals of focal therapy: selectively ablating known disease, preserving functions, and minimizing morbidity, all without compromising life expectancy. He then uses two systematic reviews, one from 2017 and one from 2019, to explain how focal therapy benefits continence and potency rates. Further presented data includes a 2020 review of evidence and reported outcomes from an October 2020 study of hemigland HIFU ablation as primary treatment for localized prostate cancer, both of which exhibit HIFU’s safety, excellent potency, and continence preservation, as well as adequate short-term prostate cancer control. Dr. Abreu also addresses comparisons to radiation and acknowledges that HIFU works well for intermediate-disease but is still controversial for low- or high-risk disease, showing a need for further study.

High Intensity Focused Ultrasound (HIFU) Ablation in a Salvage Setting

by John H. Jurige, Jr., MD | Jan 2021

John H. Jurige, Jr., MD, HIFU Program Director for the HIFU Center of Excellence in Louisville, Kentucky, discusses high intensity focused ultrasound (HIFU) ablation therapy for patients with radiorecurrent prostate cancer. He explains that this is a difficult subset of patients to treat, since they have very aggressive prostate cancer. Treatment will often fail, so one of the main objectives of treatment in this group must be quality of life preservation through avoidance of treatment morbidity and use of ADT. Focal HIFU is exceptional in this regard, even if its 5-year biochemical failure-free survival rates have historically been comparable to other forms of treatment. Dr. Jurige notes that these outcomes may be improved through better patient selection, and by starting patients on therapy at earlier stages of recurrence. Better patient selection, which can be more readily achieved with the recent improvements to prostate imaging, can also help prevent adverse effects like urethral stricture and rectal fistula. Dr. Jurige concludes by recommending that urologists give patients a full assessment and get all the studies they can before starting them on salvage HIFU after radiation.

Focal Therapy (HIFU): Functional and Oncological Outcomes

by Mark Emberton, MD, FRCS | Nov 2020

Mark Emberton, MD, FRCS, Professor of Interventional Oncology at University College London, discusses what is and is not known as of 2020 about focal therapy—particularly high intensity focused ultrasound, or HIFU—for localized prostate cancer. He observes that since there is more than a decade’s worth of research behind it, HIFU is hardly experimental anymore, and urologists are by now aware of the therapy’s safety profile, patient selection criteria, short-term outcomes, and medium-term outcomes, with only long-term outcomes still unknown. Dr. Emberton then discusses the goals of focal therapy, the technologies that can or could potentially be used to perform focal therapy, and patient eligibility criteria. He addresses the criticism that focal therapy only treats disease that does not need to be treated, explaining that while this may have been somewhat true in focal therapy’s early conservative years, the era of multiparametric MRI and PSMA PET-CT has made focal therapy more effective, and there exists plenty of research showing that focal therapy is a good alternative treatment that allows patients to maintain continence and erectile function while controlling their cancer. Dr. Emberton concludes by discussing the future of focal therapy, noting that focal therapy programs must embrace stringent quality-control measures, have a true partnership with radiology, have excellent risk stratification, and be committed to long-term follow-up through registries.