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News Release - February 22, 2019
Phase 3 Randomized Trial Data Shows SBRT has Similar Acute Safety Profile to Conventional Radiation Therapy in Patients with Localized Prostate CancerData Presented at the 2019 Genitourinary Cancers Symposium Reinforces Benefits of Short Course of Treatment Using Stereotactic Body Radiation Therapy for Low- or Intermediate-Risk Prostate Cancer
SUNNYVALE, Calif., Feb. 22, 2019 -- (Healthcare Sales & Marketing Network) -- Accuray Incorporated (NASDAQ: ARAY) announced today that data from an international, randomized, 38-center trial (PACE - Prostate Advances in Comparative Evidence) show that treatment with stereotactic body radiation therapy (SBRT) results in a similar safety profile to conventional radiation in men with low- or intermediate-risk prostate cancer. The study was presented during an oral session at the recent American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco, California.
SBRT involves the delivery of very high doses of externally-administered radiation over a small number of treatment sessions, offering convenience for patients, compared to conventional radiation therapy which requires a substantially longer course of treatment. In the PACE trial, SBRT was delivered in five sessions while conventional radiation therapy was delivered in 20 or 39 sessions. The Phase 3 trial found that despite the high dose delivered to the prostate, use of SBRT and conventional radiation therapy result in comparable rates of acute gastrointestinal and genitourinary toxicity.
"There has been considerable discussion and analysis of the risks versus the benefits of different radiation treatment techniques, especially in patients with low- or intermediate-risk prostate cancer, in large part because the side effects of treatment can impact quality of life. One of the clinical trial goals was to determine whether SBRT or a more conventionally fractionated radiotherapy schedule would provide a safer treatment choice," said Nicholas van As, M.D., Medical Director and Consultant Clinical Oncologist of The Royal Marsden NHS Foundation Trust and Reader at the ICR, London, United Kingdom and lead investigator of the trial. "These early trial results are very promising and help us better understand the effect of different radiation therapy techniques on the treatment of prostate cancer. We look forward to analyzing additional trial data as it becomes available."
The prostate gland can move unpredictably throughout the course of treatment because of normal patient bodily functions. This makes it vitally important to be able to track, detect and correct for all types of motion. The CyberKnife® System, designed to deliver SBRT, is the only radiotherapy device that can track and automatically correct for prostate motion and maintain sub-millimeter accuracy throughout treatment delivery, thereby enhancing clinicians' ability to treat effectively while preserving healthy tissue.
"The results of this randomized controlled trial add to the large body of evidence supporting the use of SBRT as a treatment option for low- and intermediate-risk prostate cancer. The data are important because they have the potential to impact clinicians' approach to the treatment of this disease," said Fabienne Hirigoyenberry-Lanson, Ph.D., Vice President Global Medical and Scientific Affairs at Accuray. "Our CyberKnife System provides a valuable option for delivering prostate SBRT. Data reinforce that treatment with the system results in minimal side effects and impact on quality of life during and after treatment."
About the PACE-B Trial
PACE-B, an international phase 3 randomized controlled trial comparing stereotactic body radiotherapy to conventionally fractionated or moderately hypofractionated external beam radiotherapy (CFMHRT) for localized prostate cancer, represents one arm of a two-part trial. Further data on this arm, as well as the second arm comparing hypofractionated SBRT to prostatectomy, will be shared when available. Out of the 874 patients enrolled by 38 institutions, 845 patients were analyzed; 431 receiving SBRT and 414 CFMHRT. Men who were unsuitable for surgery or preferred treatment with external beam radiation therapy were eligible to participate. The trial evaluated the treatment regimens across multiple effectiveness and safety metrics; toxicity measures were presented at ASCO GU.
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.
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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, the impact of data on clinicians' decision-making, 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, the company's quarterly report on Form 10-Q, filed with the SEC on February 8, 2019, and as updated periodically with the company's other filings with the SEC.
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