Californian company Accuray Inc., describing itself as the premier radiation oncology company, has announced the launch of the “Prostate Advances in Comparative Evidence” (PACE) Study, an international, multi-centre, randomised study to compare its CyberKnife® Stereotactic Body Radiation Therapy (SBRT), da Vinci-assisted and manual laparoscopic surgery and conventionally fractionated Intensity Modulated Radiation Therapy (IMRT), for the treatment of localised prostate cancer.
Currently, there is no clear gold standard for localised prostate cancer treatment and clearly the folks at Accuray are bullish enough about the performance of its system that the company is jumping in with both feet. And that’s probably not surprising, since experience with their CyberKnife prostate SBRT technology dates back to 2002 and is already the subject of 14 peer-reviewed studies involving over 7o0 patients.
There remains, however, a lack of comparative clinical data which has seemingly prevented definitive conclusions to be drawn as to which therapy can be considered the preferred treatment for localised prostate cancer.
According to Accuray, “Treatment decisions have often been made based on historical experience, aged comparisons of older treatment techniques or single modality experiences. Physicians and leading industry groups, including The Agency for Healthcare Quality and Research (AHRQ) and the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC), have called for a randomized study comparing the most popular treatment options to bring clarity to the treatment landscape.”
The PACE Study was created by a consortium of leading academic centres in Europe including the prestigious Royal Marsden NHS Foundation Trust in the UK, Center Oscar Lambret in France, Charité–Universitätsmedizin in Germany, Erasmus MC-Daniel den Hoed Cancer Center in The Netherlands, and Mount Vernon Cancer Centre again in the UK.
It is comprised of two parallel randomised arms, surgical and non surgical: Patients considered candidates for surgery are randomised to either laparoscopic prostatectomy (performed manually or through robotic assistance using da Vinci) or CyberKnife prostate SBRT. Non-surgical candidates or patients who refuse surgery will be randomised to either CyberKnife prostate SBRT or conventionally fractionated IMRT.
The ultimate goal of the study is to compare the outcomes of CyberKnife prostate SBRT, in terms of efficacy, toxicity and quality of life to da Vinci prostatectomy, manual laparoscopic prostatectomy and conventionally fractionated IMRT for early-stage, organ-confined prostate cancer. The study employs the leading quality of life tools to measure erectile function preservation, urinary and rectal toxicity, urinary incontinence and other scores related to general post treatment side effects.
The study is expected to involve 30-40 centres globally and accrue more than 1,000 patients who will be followed for 10 years. The study leaders anticipate collecting and reporting data outcomes at several interim points including one, two and five years post-treatment.
“In light of a lack of definitive, comparative data supporting any one option as the best treatment choice, about 75 percent of low risk prostate cancer patients in the US receive surgery,” said Dr. Nicholas van As, M.D, consultant clinical oncologist at the Royal Marsden NHS Foundation Trust in London. “The goal of the PACE study is to create the data needed to compare outcomes of treatment with CyberKnife prostate SBRT to surgery and IMRT, which are the accepted standard treatments for organ confined prostate cancer, to allow informed treatment decisions to be made.”
“An increasing number of patients are attracted to treatment with the CyberKnife System due to its unique ability to precisely treat the prostate while avoiding surrounding healthy tissue and critical structures, offering an effective treatment for early-stage prostate cancer,” said Euan S. Thomson, Ph.D., president and CEO of Accuray. “The rapidly expanding base of CyberKnife prostate SBRT published studies supports the benefits of this treatment for patients. Accuray believes in taking the lead in supporting studies, such as the PACE study, that will generate clinical data to support the benefits of technical innovation and provide the highest level of comparative evidence for the benefit of prostate cancer patients worldwide.”
Complete information about the PACE Study is available here.
Source: Accuray Inc.