(ChemotherapyAdvisor) – A new study will compare 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 localized prostate cancer, according to a press release from Accuray Incorporated. An international, multi-center, randomized study, known as the Prostate Advances in Comparative Evidence (PACE), will compare the three methods to support the future potential of CyberKnife SBRT as the gold standard in the treatment of organ confined prostate cancer. “This information will enable clinicians and patients to make informed treatment decisions based on the highest level of clinical evidence,” the company noted.
The PACE Study, which was created by a consortium of leading academic centers in Europe, including Royal Marsden NHS Foundation Trust, Sutton, UK, and Center Oscar Lambret, France, will randomize patients into two parallel arms: In one arm, patients considered candidates for surgery, either by clinician recommendation or patient choice, will be randomized to either laparoscopic prostatectomy (performed manually or through robotic assistance using da Vinci) or CyberKnife prostate SBRT. In the other arm, non-surgical candidates (or patients who refuse surgery) will be randomized to either CyberKnife prostate SBRT or conventionally fractionated IMRT, according to the company.
Comparisons will be made of clinical outcomes post-treatment, including efficacy, toxicity and quality of life following treatment. Quality of life tools will be implemented to measure erectile function preservation, urinary and rectal toxicity, urinary incontinence and other scores related to general post treatment side effects. The study, which will enroll up to 1,000 patients across 30 to 40 clinical sites, will involve collecting and reporting data outcomes at several interim points including 1, 2, and 5 years post-treatment.