Background
In the United States, prostate cancer is the most common type of cancer in men, with 186,000 new cases and 28,600 deaths reported in 2008. It is the second leading cause of cancer death in American men (lung cancer is first). The normal prostate is about the size of a walnut. It is located under the bladder and in front of the rectum; the urethra runs directly through the prostate. The prostate is not essential for life, but it is important for reproduction. Its function is critical for fertilization, sperm transit, and sperm survival. Prostate cancer originates from the epithelial cells within the gland; therefore, prostate cancer is classified as an adenocarcinoma or a glandular cancer. Screening exams for prostate cancer include digital rectal examination and a blood test to measure prostate-specific antigen (PSA) levels. A physician can only make a definitive prostate cancer diagnosis based on biopsy results.
Treatment
Common treatment options for men with localized prostate cancer include radical prostatectomy (retropubic, perineal, or laparoscopic [with or without robotic assistance]) and radiation therapy (external beam radiation therapy and brachytherapy). Less common therapies or management options are androgen deprivation therapy, cryoablation, watchful waiting, and active surveillance. Although these terms are not well defined in the published literature and have sometimes been used interchangeably, active surveillance implies a higher degree of monitoring, including PSA levels and prostatic biopsies, in order to guide the decision of when to intervene whereas watchful waiting implies a more passive approach focused on treatment of symptoms associated with disease progression. The choice of therapy depends on a number of factors, including cancer stage, histologic grade, presence of comorbidities, and patient preferences.
Focused Ultrasound Treatment
Focused ultrasound is a completely noninvasive, radiation free method to treat localized prostate cancer. Using this treatment modality in conjunction with image guidance, the physician directs a focused beam of acoustic energy to a selected volume in the patient’s prostate gland. The energy from the acoustic beam heats the targeted tissue at the focal point and creates a temperature elevation that thermally coagulates the targeted small volume of cells within seconds. This process is repeated until the entire selected volume or the entire gland is thermally destroyed. Several systems for focused ultrasound ablation of prostate tissue are available in various geographical regions, each differing in their guidance method (ultrasound vs. magnetic resonance imaging [MRI]) and type of transducer used (endorectal vs. intraurethral).
Benefits of Focused Ultrasound
The potential benefits of focused ultrasound for the treatment of prostate cancer include:
- It is a noninvasive, low morbidity treatment with a short recovery time and a quick return to work and the activities of normal life (usually the next day).
- A single therapy session is usually all that is required.
- It is reported to have a low complication rate, especially when considering post procedure impotence and incontinence.
- Focused ultrasound treatment does not use ionizing radiation, which means that it is possible to repeat treatment, it is possible to offer it as a salvage therapy for patients who fail radiation treatment, and it does not prevent pursuing other treatment options.
Patient Selection Criteria
Due to the fact that there are several devices with different technical limitations as well as different therapeutic approaches (transrectal vs. transurethral) and guidance systems (ultrasound vs. MRI), the selection criteria below are generalized with comments where relevant.
- The patient has been diagnosed with prostate cancer as confirmed by prostate biopsy.
- The prostate cancer is localized (visible on T1 or T2 images).
- Focused ultrasound is a first line therapy only if the patient is not a candidate for surgical treatment.
- Focused ultrasound is a salvage therapy option for a patient who experiences local recurrence after radiotherapy, radical prostatectomy, or previous focused ultrasound treatment.
- The patient’s prostate shows no calcification that induces an acoustic shadow.
- The patient has no permanent radioactive seed implants in the rectal wall.
- The patient does not have a urinary tract fistula or rectal fistula.
- The patient does not have an implant (stent, catheter) that is within 1 cm of the treatment area.
- For the transrectal approach, the patient must not have a rectal or anal fibrosis, a rectal or anal stenosis, or any anomalies that would make endorectal probe insertion difficult. Additionally, the patient must have no history of intestinal pathology.
- For the transrectal approach, the patient must have no anatomical anomaly of the rectum or anomaly of the rectal mucous membrane.
- The patient may not have an artificial sphincter, penile prosthesis, or intraprostatic implant (such as a stent).
- The patient must not have an active urogenital infection.
- For some systems, the patient’s gland size should not be bigger than 40 cc.
- Focused ultrasound treatments performed using MRI guidance are contraindicated in men with MRI-related issues (e.g., the presence of pacemakers or metallic implants that are incompatible with MRI, sensitivity to MRI contrast agents, or the inability to fit into the MRI bore).
Clinical Trials
Physicians have used focused ultrasound to treat more 30,000 patients worldwide for prostate cancer. Clinical studies* conducted at such world-renowned medical centers as the University College of London Hospitals, Sloan-Kettering Institute, the University of North Carolina (Chapel Hill), Duke University Medical Center, the Cleveland Clinic Foundation, Vanderbilt University Medical Center, the University of Texas M.D. Anderson Cancer Center, UCLA Medical Center, Yale University, Walter Reed Army Medical Center, and Tulane University include:
- High-Intensity Focused Ultrasound in Treating Patients With Localized Prostate Cancer
- High-Intensity Focused Ultrasound Ablation in Treating Patients With Progressive Prostate Cancer
- High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate Cancer
- Treatment of Localized Prostate Cancer With High Intensity Focused Ultrasound Using the Sonablate® 500 System in Canada
- Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Risk Prostate Cancer: Feasibility Study
- A Multicenter Clinical Study of the Sonablate®500 for the Treatment of Locally Recurrent Prostate Cancer With HIFU
Regulatory Approval
The following geographical regions have one or more focused ultrasound devices approved for the treatment of prostate cancer as either a primary or salvage treatment: Europe (CE Mark), Canada, Russia, Australia, Korea, Malaysia, Indonesia, South America, and the Middle East.
In the United States, no device with FDA approval is currently available, although physicians are conducting clinical research toward that goal.
Reimbursement
Some European countries have coverage; in other countries, coverage may be available on a case and site basis.
Patient Advocacy
Sites Offering Focused Ultrasound Treatment
HIFU PLANET
The HIFU PLANET website was set up to provide patients with useful information relating to prostate cancer treatments and particularly on Ablatherm® HIFU treatment. The information displayed on HIFU PLANET website is targeted to the general public and to physicians seeking information on prostate cancer and Ablatherm® HIFU technology.The information available on HIFU PLANET web site is not a substitute to professional diagnosis and to discussions with your physician and/or urologist. http://www.hifu-planet.co.uk/
US HIFU and International HIFU
USHIFU, LLC ("US HIFU") is a privately held health care company focused on treating primary and recurrent prostate cancer using HIFU, a minimally invasive outpatient procedure which potentially improves patients’ quality of life. US HIFU was founded in 2004 and is headquartered in Charlotte, N.C. http://www.ushifu.com/
International HIFU is a subsidiary of USHIFU, LLC (“US HIFU”), a privately held healthcare company focused on treating diseases, such as prostate cancer, with high intensity focused ultrasound (“HIFU”) technologies. US HIFU was founded in 2004 and is headquartered in Charlotte, N.C. US HIFU manufactures, distributes and manages delivery of care with the Sonablate® 500 (“Sonablate”) medical device, designed to treat prostate disease with HIFU energy (“Sonablate HIFU”). http://www.internationalhifu.com/index.php
HIFU Center
Dr. Stephen Scionti is the HIFU Program Director of Prostate Cancer Ablative Surgery at The Joel E. Smilow Comprehensive Prostate Cancer Center at New York University Langone Medical Center and Clinical Associate Professor of Urology at New York University School of Medicine. http://www.nyhifucenter.com/
Equipment Manufacturers
Ablatherm® HIFU by EDAP TMS
http://www.edap-tms.com/products-services/ablatherm-hifu
Sonablate® 500 by Focus Surgery, Inc.
http://www.focus-surgery.com/Sonablate500.htm
ExAblate for Prostate Cancer by InSightec LTD
http://www.insightec.com/ExAblate-ProstateResearch.html
Profound Trans-urethral system by Profound Medical, Inc.
http://www.profoundmedical.com/
Notable Papers
Wilt TJ, MacDonald R, Rutks I, Shamilyan TA, Taylor BC, Kane RL. Systematic review: comparative effectiveness and harms of treatments for clinically localized prostate cancer. Ann Intern Med 2008 Mar 18;148(6):435-48. Epub 2008 Feb 4.
Blana A, Walter B, Rogenhofer S, Wieland WF. High-intensity focused ultrasound for the treatment of localized prostate cancer: 5-year experience. Urology 2004 Feb;63(2):297-300.
Thüroff S, Chaussy C, Vallancien G, Wieland W, Kiel HJ, Le Duc, Desgrandchamps F, De la Rosette JJ, Gelet A. High-intensity focused ultrasound and localized prostate cancer: efficacy results from the European multicentric study. J Endourol 2003 Oct;17(8): 673-7.
Blana A, Murat FJ, Walter B, Thuroff S, Wieland WF, Chaussy C, Gelet A. First analysis of the long-term results with transrectal HIFU in patients with localised prostate cancer. Eur Urol 2008 Jun;53(6):1194-1203. Epub 2007 Nov 5.
Chopra R, Baker N, Choy V, Boyes A, Tang K, Bradwell D, Bronskill MJ MRI-compatible transurethral ultrasound system for the treatment of localized prostate cancer using rotational control. Med Phys 2008 Apr;35(4):1346-57.
Crouzet S, Murat FJ, Rouviere O, Poissonnier L, Martin X, Colombel M, Chapelon JY, Gelet A. Oncological outcomes of high-intensity focused ultrasound for localized prostate cancer in 880 consecutive patients. Eur Urol Suppl 2011;10(2):51.