SUNNYVALE, Calif., Feb. 16,
2023 /PRNewswire/ -- Accuray Incorporated (NASDAQ:
ARAY) announced today that data from the randomized, multicenter
trial PACE-A (PACE - Prostate Advances in Comparative Evidence)
indicates that stereotactic body radiation therapy (SBRT), in
comparison to surgery, better preserves urinary continence and
sexual function in men with localized prostate cancer. The study,
which was led by The Royal Marsden NHS Foundation Trust and The
Institute of Cancer Research, London, is being presented during an oral
session at the American Society of Clinical Oncology Genitourinary
Cancers Symposium (ASCO GU) in San
Francisco, California.
123 men from 10 UK centers were enrolled in the trial, with 59
ultimately treated with SBRT and 50 with surgery. An analysis of
patient reported outcomes found that at two years, significantly
fewer patients (4.5%) treated with SBRT reported needing to use
urinary pads, which manage urinary incontinence, compared with
surgery (47%)1. Patients treated with SBRT also reported
better sexual function after two years than those treated with
surgery2.
While moderate or serious bowel problems were not reported by
many men in the study, those treated with SBRT were more likely
(16%) than surgical patients to report minor problems
(0%)3.
SBRT is a highly targeted form of external beam radiation
therapy that involves the delivery of very high doses of radiation
over a small number of treatment sessions, offering convenience for
patients. The delivery of radiation is an outpatient, non-invasive
procedure that does not require general anesthesia and most
patients will not require a long recovery period. In the PACE-A
trial patients were treated with SBRT delivered in 5 sessions over
1-2 weeks or surgery, either laparoscopic or robotically assisted
prostatectomy.
Professor Nicholas van As, M.D., Medical Director and Consultant
Clinical Oncologist of The Royal Marsden NHS Foundation Trust and
Professor in Precision Prostate Radiotherapy at The Institute of
Cancer Research, London and lead
investigator of the trial, said:
"This world-first study reveals that SBRT, an advanced form of
radiotherapy now widely available across the UK, is often kinder
and can mean less long-term side effects than surgery for prostate
cancer patients.
"One of the biggest concerns for men I see in clinic ahead of
treatment for prostate cancer is whether it will make them
incontinent, and many worry about the impact on their sexual
function too. While there is a risk both SBRT and surgery will
cause problems, these results suggest SBRT is less likely to.
"Going forwards, these results should support clinicians in
facilitating important discussions with prostate cancer patients
about whether to opt for SBRT or surgery, helping them make an
informed decision based on their individual needs and
concerns."
The CyberKnife® System, designed to deliver SBRT,
features a linear accelerator mounted to a robotic arm that aims
radiation beams from potentially thousands of unique angles,
targeting only the tumor while minimizing radiation dose to healthy
tissue. The system's accuracy is sub-millimeter, meaning its
pinpoint precision is less than the thickness of a coin, even as
the prostate moves unpredictably. The CyberKnife System uses the
Accuray-proprietary artificial intelligence (AI)-driven
Synchrony® technology to detect when the prostate moves
and synchronizes the treatment delivery beam to the random movement
of the prostate in real-time throughout the entire treatment
session.
Seth Blacksburg, M.D., MBA, Vice President and Chief Medical
Officer Americas region at Accuray said, "Men undergoing treatment
for prostate cancer want a highly accurate, effective, and
efficient treatment that allows them to get back to their daily
lives with minimal-if-any impact on long-term urinary, rectal, and
sexual function. The results of the PACE-A study support and expand
upon previous important investigations—such as the ProtecT trial
published in the New England Journal of Medicine in 2016—and
indicate that SBRT can do just that.
Dr. Blacksburg continued, "A large body of evidence highlights
the versatility of the CyberKnife® platform to
effectively deliver SBRT to cure prostate cancer. The system's
ability to deliver extremely precise and accurate treatment to a
moving target allows physicians and patients alike to feel
confident that cancers at various stages of disease are addressed
with minimal impact on normal tissue."
About the PACE-A Trial
PACE-A, a randomized controlled trial comparing SBRT to surgery -
laparoscopic or robotically assisted prostatectomy - for localized
prostate cancer, represents one study of a three-study trial
platform. It is sponsored by The Royal Marsden and managed by The
Clinical Trials and Statistics Unit at The Institute of Cancer
Research (ICR). Of the 123 patients enrolled by 10 United Kingdom
centers participating in the PACE-A trial, 109 patients received
treatment; 59 receiving SBRT and 50 surgery. Androgen deprivation
was not permitted. The trial evaluated the treatment regimens
across quality-of-life measures that were presented at ASCO GU.
Toxicity results from PACE-B, comparing SBRT to conventionally
fractionated or moderately hypofractionated external beam
radiotherapy (CFMHRT) for localized prostate cancer, has been
published in The Lancet Oncology. Five year efficacy
outcomes for PACE-B (the primary outcome measure) should be
available later this year. Outcomes of the PACE-C trial, comparing
hypofractionated SBRT to conventionally fractionated or moderately
hypofractionated external beam radiotherapy (CFMHRT) in
intermediate and high-risk patients requiring 6 months of hormone
therapy, will be shared when available. PACE-C closed to
recruitment in June 2022.
All three of the PACE studies are sponsored by The Royal Marsden
NHS Foundation Trust and coordinated by the Clinical Trials and
Statistics Unit at the ICR. PACE-A is funded by Accuray and Varian,
a Siemens Healthineers company, PACE-B is funded by Accuray and
endorsed by Cancer Research UK, and PACE-C is funded by The Royal
Marsden Cancer Charity.
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.
Important Safety Information
For Important Safety Information please refer to
https://www.accuray.com/safety-statement
Media Contact:
Beth
Kaplan
Public Relations Director,
Accuray
+1 (408)
789-4426
bkaplan@accuray.com
1 At two years, 44 of those treated with SBRT and 32
of those treated with surgery responded to this query, with two of
the SBRT cohort and 15 of the surgical group reporting the use of
urinary pads.
2 The Expanded Prostate Cancer Index-Short Form
(EPIC-26) questionnaire, which is used for measuring health-related
of life, was applied here. At 2 years, 41 SBRT patients reported an
EPIC sexual subdomain score with mean of 58, compared with 30
surgical patients who reported a mean score of 29.3.
3 At two years, 46 of those treated with SBRT and 31of
those treated with surgery responded to this query, with 7 of the
SBRT cohort reporting a moderate/serious problem with bowel
symptoms and none of the surgical cohort reporting
problems.
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SOURCE Accuray Incorporated