Data Published in The Lancet Oncology Indicate Men With Prostate Cancer Treated With the Accuray CyberKnife® Platform Experienced a Lower Incidence of Bladder Side Effects Than Those Treated With Conventional Linear Accelerators

• Latest research published in The Lancet Oncology: suggests bladder side effects were experienced half as often with CyberKnife SBRT as with conventional linear accelerator delivered SBRT two years after treatment
• Almost 20 years of global clinical data: shows the non-surgical CyberKnife platform provides excellent disease control with low rates of toxicity for men with prostate cancer

SUNNYVALE, Calif., Oct. 11, 2022 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that results of the PACE-B – Prostate Advances in Comparative Evidence – trial were published in The Lancet Oncology, a leading global peer-reviewed oncology journal. As previously reported, the trial indicates that two years after treatment, patients treated with the company's CyberKnife^® robotic radiotherapy platform, when compared with conventional linear accelerators, have a lower incidence of late grade two or higher bladder toxicities, which are associated with prostate cancer stereotactic body radiation therapy (SBRT) treatments. This is the most recent data highlighting the benefits of the platform which has been used in the treatment of prostate cancer for almost 20 years.

Chief Investigator Professor Nicholas van As, Medical Director and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust, and Reader in Precision Prostate Radiotherapy at The Institute of Cancer Research, London, said: "At The Royal Marsden and the ICR we are focused on developing smarter, better and kinder treatments for people with cancer. This includes harnessing innovations in radiotherapy technology, such as SBRT, to target tumours more effectively and improve patient outcomes and, thanks to funding from The Royal Marsden Cancer Charity, we have two state-of-the-art CyberKnife machines in the hospital.  

"Radiotherapy can sometimes cause challenging bladder problems for men with prostate cancer, including passing urine more regularly and cystitis. These interesting new results suggest SBRT through CyberKnife can be delivered with similarly low levels of side effects as standard radiotherapy, which is typically given to patients over four to eight weeks, over a much shorter time period.

"So far, the findings from this study are promising and, over the next few years, we will analyze the long-term side effects and outcomes of SBRT. We hope this trial will eventually change practice and enable us to deliver curative treatment over fewer days, sparing patients numerous hospital visits."

In 2020, more than 1.4 million men worldwide were diagnosed with prostate cancer¹. While it is typically a slow-growing and manageable disease, long-term treatment-related side effects can affect patients' physical and mental well-being for the rest of their lives. Technology that can minimize the risk of these side effects is key. The PACE data are noteworthy because they signal that men treated with CyberKnife SBRT are less likely to experience long-term side effects that can impact them over the course of their lives than men receiving conventional linear accelerator delivered SBRT.

SBRT treatments involve the delivery of very high doses of externally administered radiation over a small number of sessions, offering convenience for patients, compared with conventional radiation therapy which requires substantially more treatment sessions. In the PACE trial, SBRT was delivered in 5 sessions while conventional radiation therapy was delivered in 20 or 39 sessions.

"Clinicians using the CyberKnife^® System pioneered prostate SBRT and are responsible for the publication of the vast majority of scientific studies on this treatment modality. The system is the only radiation therapy device supported by years of published clinical follow-up with a large number of patients, and these studies show that using the CyberKnife instead of conventional linear accelerators for prostate SBRT reduces significantly pain and urine frequency which have a real impact on daily activities," said Jean-Philippe Pignol, M.D., Ph.D., chief medical & technology officer at Accuray. "As the adoption of SBRT (ultra-hypofractionated radiotherapy) for the treatment of prostate cancer continues to grow, we anticipate that CyberKnife SBRT will become an increasingly important part of a hospital's program for the treatment of low- and intermediate-risk, and recurrent disease, especially since prostate patients represent a large volume of radiotherapy indications."

What makes the CyberKnife^® System unique is that it is the only fully robotic radiation delivery system. The robotic design, coupled with real-time imaging, enables the system to deliver a maximum dose of radiation directly to the tumor from potentially thousands of unique angles with sub-millimeter precision. The system does this by using the Accuray proprietary artificial intelligence (AI)-driven Synchrony^® technology to track and adapt for tumor or patient movement during treatment to minimize radiation exposure to healthy organs and tissues.

This capability is especially important when treating prostate cancer, because the prostate gland can move as much as 10 mm in as little as 30 seconds in an unpredictable manner, often caused by normal patient bodily functions such as filling of the bladder, gas in the bowel, or even slight patient movement during the procedure. In addition, the prostate is surrounded by sensitive organs and tissues.

About the PACE-B Trial
The PACE trial data provides level 1 clinical evidence – the strongest level of evidence on which to guide practice changes. PACE-B is a prospective, randomized trial conducted in 35 centers in the UK, Canada and Ireland, comparing five-fraction stereotactic body radiotherapy (SBRT) to conventionally fractionated or moderately hypofractionated external beam radiotherapy (CFMHRT) for localized prostate cancer. The PACE-B trial is funded by Accuray, sponsored by The Royal Marsden and coordinated by the ICR-CTSU at The Institute of Cancer Research, London. Of the 874 patients enrolled, data up to two years on 844 patients treated with radiotherapy were analyzed; 414 receiving SBRT and 430 standard radiotherapy. Forty-one percent of men treated with SBRT in the study received treatment using the CyberKnife platform.

About Accuray
Accuray is committed to expanding the powerful potential of radiation therapy to improve as many lives as possible. We invent unique, market-changing solutions designed to deliver radiation treatments for even the most complex cases—while making commonly treatable cases even easier—to meet the full spectrum of patient needs. We are dedicated to continuous innovation in radiation therapy for oncology, neuro-radiosurgery, and beyond, as we partner with clinicians and administrators, empowering them to help patients get back to their lives, faster. Accuray is headquartered in Sunnyvale, California, with facilities worldwide. To learn more, visit www.accuray.com or follow us on Facebook, LinkedIn, Twitter, and YouTube.

Safe Harbor Statement
Statements made in this press release that are not statements of historical fact are forward-looking statements and are subject to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release relate, but are not limited, to expectations regarding the importance of CyberKnife^® SBRT to the treatment programs of hospitals, clinical applications, clinical results, patient experiences and patient outcomes. These forward-looking statements involve risks and uncertainties. If any of these risks or uncertainties materialize, or if any of the company's assumptions prove incorrect, actual results could differ materially from the results expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the effect of the current global economic environment and the COVID-19 pandemic on the operations of the company and those of its customers and suppliers, the company's ability to achieve widespread market acceptance of its products; the company's ability to develop new products or improve existing products to meet customers' needs; the company's ability to anticipate or keep pace with changes in the marketplace and the direction of technological innovation and customer demands and such other risks identified under the heading "Risk Factors" in the company's Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the "SEC") on August 17, 2022, and as updated periodically with the company's other filings with the SEC.

Forward-looking statements speak only as of the date the statements are made and are based on information available to the company at the time those statements are made and/or management's good faith belief as of that time with respect to future events. The company assumes no obligation to update forward-looking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws. Accordingly, investors should not put undue reliance on any forward-looking statements.

Media Contact
Beth Kaplan                                                                            
Public Relations Director, Accuray                                         
+1 (408) 789-4426                                                                    
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¹ https://gco.iarc.fr/today/data/factsheets/cancers/27-Prostate-fact-sheet.pdf

SOURCE Accuray Incorporated