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