Largest Prostate SBRT Studies to Date Show Accuray CyberKnife® System Provides Excellent Prostate Cancer Survival Rates in Five or Fewer Sessions

SUNNYVALE, Calif., Sept. 25, 2018 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that published data from two prospective, multi-center studies using differing protocols provide consistent results and reinforce the use of the CyberKnife^® System for the effective management of low- and intermediate-risk prostate cancer. These studies are the largest conducted to date evaluating stereotactic body radiation therapy (SBRT) in patients with localized prostate cancer. The studies were recently published online in the International Journal of Radiation Oncology*Biology*Physics and in the European Urology Oncology.

The CyberKnife System delivers radiation with sub-millimeter precision, enhancing clinicians' ability to treat effectively while preserving healthy tissue. In addition to clinical benefits, SBRT is more convenient for patients and has been shown to be less costly than long courses of intensity-modulated radiation therapy (IMRT).

Growing clinical evidence suggests that dose-escalation may translate to improved clinical outcomes for prostate cancer. Research suggests that, unlike most tumors, prostate cancer cells are highly sensitive to the amount of radiation dose delivered per fraction or treatment session. In recent years, this has led clinicians to consider hypo-fractionated schedules—the delivery of a higher dose per fraction in fewer fractions than conventional schedules—with promising results. SBRT, which combines a high degree of targeting accuracy with very high doses of extremely precise, externally-delivered radiation over four to five sessions, provides an option for accomplishing this goal.

Highlights of the Multi-Center Studies

Pinpoint precision results in exceptional survival rates
Prostate SBRT administered by the system resulted in the following disease-free survival rates:

• 97% - 100% for low-risk patients
• Superior to the 92% - 94% from conventional radiation therapy historic data
• Equivalent to low dose rate (LDR) brachytherapy and high dose rate (HDR) brachytherapy without the inconvenience and risk associated with invasive seed and catheter implants
• 88% - 97% for intermediate-risk patients
• Equal to or higher than the 85% - 90% reported with conventional radiation therapy without the inconvenience of daily visits over several weeks

Minimal toxicity even with high radiation dose
Despite the high dose delivered to the prostate, side effects were uncommon (less than two percent grade 3 or higher toxicities) and were similar to other radiation therapy procedures without the need for invasive rectal balloons or spacers to spare the rectal wall.

"Our study treated over 300 prostate cancer patients across 21 centers throughout the United States. The CyberKnife's unique architecture tracks and automatically corrects for prostate motion, delivering radiation with sub-millimeter accuracy. This exceptional precision allowed us to give a more effective dose of radiotherapy, which translated into superior cancer control. Since we were able to avoid the healthy tissues which lie immediately adjacent to the prostate, side effects were uncommon," said Robert M. Meier, MD, medical director of the Swedish Radiosurgery Center in Seattle and lead investigator of the study published in the International Journal of Radiation Oncology*Biology*Physics.

Added Donald B. Fuller, MD, radiation oncologist at Genesis Healthcare Partners in San Diego and lead investigator of the European Urology Oncology study, "We evaluated an SBRT dosing regimen designed to emulate successful high dose rate (HDR) brachytherapy plans and delivered in four visits. Study outcomes demonstrate that CyberKnife^® prostate SBRT is safe and effective for low- and intermediate-risk prostate cancer patients, producing a lower PSA nadir level than previously reported with other external radiotherapy techniques (< 0.1 ng/mL at 4 years and beyond), with minimal impact on quality of life during and after treatment. Of note, our treatment plans required steep dose fall-off from high-dose regions close to the bladder, urethra and rectum that would be difficult to deliver safely without the unique continual image-guidance and automatic correction of the beam aim made possible by the CyberKnife System."

"These multi-center studies reinforce the value the CyberKnife System can bring to a hospital's prostate cancer treatment program and its potential to change the way the disease is treated by many physicians," said Fabienne Hirigoyenberry-Lanson, PhD, Vice President Global Medical and Scientific Affairs, at Accuray. "The system enables clinical teams to achieve their treatment objectives, while providing a cost-effective, non-invasive option that is more convenient for patients. More than 20,000 prostate cancer patients have been treated with the CyberKnife System, clearly demonstrating the importance of these benefits to healthcare professionals and patients alike." 

About Accuray
Accuray Incorporated (Nasdaq: ARAY) is a radiation oncology company that develops, manufactures and sells precise, innovative treatment solutions that set the standard of care with the aim of helping patients live longer, better lives. The company's leading-edge technologies deliver the full range of radiation therapy and radiosurgery treatments. For more information, please 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 clinical applications, clinical results, patient experiences and outcomes, and Accuray's leadership position in radiation oncology innovation and technologies. 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 company's ability to achieve widespread market acceptance of its products, including new product offerings, the company's ability to develop new products or enhance existing products to meet customers' needs, delays in the development or release of new offerings 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 24, 2018 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.

SOURCE Accuray Incorporated

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