Accuray CyberKnife® System Provides Excellent Disease Control for Men with Recurrent Prostate Cancer, a Medical Condition with Few Viable Treatment Options

SUNNYVALE, Calif., Jan. 8, 2020 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today data from a prospective study which showed that at five years, stereotactic body radiation therapy (SBRT) administered with the CyberKnife^® System provided excellent disease control with low rates of toxicity in men with locally recurrent prostate cancer after previous treatment with radiation therapy. Importantly, 69 percent of men required no androgen deprivation therapy (ADT) treatment within the first five years following CyberKnife prostate SBRT. ADT, also known as "hormone therapy," is the most common treatment given for recurrent prostate cancer. However, its use is associated with unfortunate side effects including loss of libido, hot flashes, bone fractures, loss of muscle mass and physical strength, and weight gain¹. The study was recently published online in the International Journal of Radiation Oncology*Biology*Physics.

Hypofractionated radiation therapy involves the delivery of higher doses of radiation over a smaller number of treatment sessions, compared to conventional radiation therapy which requires a substantially longer course of treatment. SBRT uses advanced techniques to deliver ultra-hypofractionated radiation therapy — very high doses of radiation are administered over several days. This treatment process necessitates an extremely high degree of accuracy and precision. The CyberKnife System, designed to deliver SBRT, is the only radiotherapy device that can maintain sub-millimetric accuracy with continual imaging and automatic beam delivery corrections, including rotation, throughout treatment delivery, making it easier for clinicians to effectively treat patients while minimizing dose to healthy tissue.

Click here to see how the CyberKnife System treats prostate cancer.

"Men diagnosed with recurrent prostate cancer after previous radiation therapy have few treatment choices. Most, if treated, receive only ADT which has the potential for long-lasting 'whole body' side effects while rarely eradicating the tumor completely," said Donald B. Fuller, M.D., at Genesis Healthcare Partners in San Diego, California and lead investigator of the study. "This study demonstrates that prostate SBRT delivered using the CyberKnife System offers a viable, non-invasive option for an underserved patient population and most typically delays the need for ADT for greater than five years, which would provide substantial quality of life benefits. From a technology viewpoint, the inherent sub-millimeter accuracy of the CyberKnife System due to its highly unique tracking method was critical to the success and safety of this protocol, allowing the dose to be delivered to the prostate with no additional expansion of the target volume."

Click here to learn about how Dr. Fuller uses the CyberKnife System in his practice.

Study Highlights
The study titled, "Retreatment for Local Recurrence of Prostatic Carcinoma After Prior Therapeutic Irradiation: Efficacy and Toxicity of HDR-Like SBRT," evaluated 50 patients with biopsy-proven recurrent prostate cancer diagnosed at least two years after initial treatment. Forty-three patients had previously received treatment with conventionally fractionated radiation therapy and seven patients had received treatment with another method (five brachytherapy, one SBRT and one radical prostatectomy followed by post-prostate bed salvage radiation therapy). This study demonstrated:

• At five years, the disease-free survival (DFS) rate was 60 percent, indicating patients experienced no signs or symptoms of their cancer over that time period. This rate is within the reported range for salvage brachytherapy and comparable to reported salvage radical prostatectomy results, but without the need for hospitalization, anesthesia, and long recovery times typically associated with these treatments;
• The median prostate specific antigen (PSA) decreased to 0.16 ng/mL at five years, similar to initial treatment with brachytherapy and lower than typical conventional fractionation, based on results from other studies;
• No grade two or higher gastrointestinal (GI) events were reported. Genitourinary (GU) toxicity was lower than reported rates for salvage radical prostatectomy and seems less frequent after prior standard external radiation treatment.

"This study is significant because it highlights a potential new option for extending symptom-free survival in men with locally recurrent prostate cancer previously treated with radiation therapy," said Fabienne Hirigoyenberry-Lanson, Ph.D., vice president global medical and scientific affairs, at Accuray. "The data reinforces the benefits of the CyberKnife^® System's robotic design and motion synchronization capabilities and show why CyberKnife prostate SBRT is becoming the treatment of choice by clinicians who want a high precision, versatile and non-invasive option that provides excellent disease control with minimal side effects."

About the CyberKnife System
The CyberKnife System is the only robotic radiosurgery system that offers highly precise, non-surgical treatment for tumors and lesions anywhere in the body—including the brain, breast, kidney, liver, lung, pancreas, prostate and spine. The CyberKnife System tracks and automatically adapts for tumor or patient movement during treatment, delivering the radiation dose directly to the target with sub-millimeter precision. Synchrony^® motion tracking and correction technology expands on the CyberKnife System's unique motion synchronization capabilities to provide additional precision when treating tumors that move with respiration. The high level of accuracy in dose delivery made possible by the system gives clinical teams the confidence to deliver state-of-the-art treatments for a wide range of cancers and functional disorders, without sacrificing patients' quality of life.

About Accuray
Accuray Incorporated (Nasdaq: ARAY) develops, manufactures and sells radiotherapy systems that are intended to make cancer treatments shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives. Our radiation treatment delivery systems in combination with fully-integrated software solutions set the industry standard for precision and cover the full range of radiation therapy and radiosurgery procedures. 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 and improvements; the company's ability to develop new products or improve existing products to meet customers' needs; the company's limited long-term clinical data supporting the safety and efficacy of its products, including product improvements, for certain users and such other risks identified under the heading "Risk Factors" in the company's quarterly report on Form 10-Q, filed with the Securities and Exchange Commission (the "SEC") on November 6, 2019 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 Contacts
Beth Kaplan                                                                 
Public Relations Director, Accuray                                
+1 (408) 789-4426                                                          
bkaplan@accuray.com                                                 

Jayme Maniatis
MSLGROUP
+1 (781) 684-0770
accuray@mslgroup.com

Investor Contacts
Lytham Partners
Joe Diaz, Joe Dorame or Robert Blum
+1 (602) 889-9700
aray@lythampartners.com

¹ https://www.cancer.gov/types/prostate/prostate-hormone-therapy-fact-sheet#q6. Accessed 11/19/2019.

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SOURCE Accuray Incorporated