LARGEST CLINICAL STUDIES TO DATE* SUPPORT CYBERKNIFE® SBRT FOR LOCALIZED PROSTATE CANCER

 

Two large prospective, multi-institutional and CyberKnife® System only clinical studies report excellent clinical outcomes at five years post-treatment. These studies, conducted at academic and community medical centers across the United States, provide robust clinical data supporting the safety and efficacy of CyberKnife Stereotactic Body Radiotherapy (SBRT) for patients with low- and intermediate-risk prostate cancer. The following table describes and differentiates these studies. 

Study Title Prospective evaluation of CyberKnife System stereotactic radiosurgery for low and intermediate risk prostate cancer: Homogenous Dose Distribution https://clinicaltrials.gov/ct2/show/NCT00643994 Prospective evaluation of CyberKnife System stereotactic radiosurgery for low and intermediate risk prostate cancer: Emulating HDR brachytherapy dosimetry
https://clinicaltrials.gov/ct2/show/study/NCT00643617
Principal Investigator Dr. Robert M. Meier, Swedish Radiosurgery Center, Swedish Medical Center, Seattle Dr. Donald B. Fuller, CyberKnife Centers of San Diego, A Division of Genesis Healthcare Partners, San Diego
Number of Patients Analyzed 309 patients:
• 172 low-risk
• 137 intermediate-risk
259 patients:
• 112 low-risk
• 147 intermediate-risk
Dose Prescription • 36.25 Gy/five fractions to PTV
• 40 Gy to the prostate
• 36.25 Gy/five fractions to PTV
• 40 Gy to the prostate
Isodose Distribution Homogenous dose distribution; typical external beam dose distribution with the same dose to the entire prostate Heterogeneous dose distribution; typical brachytherapy dose distribution with higher dose to the peripheral and posterior regions. Studies have shown a higher density of cancer cells in these regions.
Isodose Distribution Screenshot
Efficacy Median 5-year DFS**
• 97.3% for low-risk
• 97.1% for intermediate-risk
Median 5-year DFS**
• 100% for low-risk
• 88.5% for intermediate-risk
Toxicity Despite the large dose delivered to the prostate, toxicity rates compare favorably to conventional radiotherapies, based on results from other studies. Despite the large dose delivered to the peripheral and posterior regions, toxicity rates compare favorably to conventional radiotherapies, based on results from
other studies.
Published Meier R., et al. “Multicenter Trial of Stereotactic Body Radiotherapy for Low- and Intermediate-Risk Prostate Cancer: Survival and Toxicity Endpoints” Int. J. Radiat. Oncol. Biol. Phys. 2018; 102(2): 296-303 https://doi.org/10.1016/j.ijrobp.2018.05.040 Fuller D.B. et al. “Phase 2 Multicenter Trial of Heterogeneous-dosing Stereotactic Body Radiotherapy for Low- and Intermediate-Risk Prostate Cancer: 5-year Outcomes” European Urology Oncology. 2018; Article in Press https://doi.org/10.1016/j.euo.2018.06.013

Proven


The CyberKnife System is recognized and established for prostate SBRT
• Supported by the largest prospective prostate SBRT studies to date* on low- and intermediate-risk prostate cancer2,3.These studies provide reassurance to patients and providers that excellent clinical results are reproducible at any CyberKnife center
• Supported by the most extensive clinical experience with 15 years of expertise4,5, nearly 100 peer-reviewed articles,and more than 20,000 prostate patients treated

Precise

The CyberKnife System’s precise robotic treatment streamlines prostate SBRT

  • Automatically delivers a wide range of non-coplanar beams which improves sparing of surrounding organs and normal tissue compared to conventional coplanar beams
  • Automatically maintains sub-millimeter accuracy with continual intrafraction imaging and prostate motion synchronization, including rotation, throughout treatment delivery
  • The prostate may move unpredictably during treatment delivery as much as 10 mm in as little as 30 seconds10 and rotate as much as 10 degrees11
  • When the target volume includes the proximal seminal vesicle, rotational corrections may be important to prevent under-dosing of the seminal vesicles12

Effective

The CyberKnife System yields clinical outcomes that compare favorably to historical data

Excellent disease-free survival rates at five years2,3 and 10 years13 for low-risk patients

  • Superior to conventional radiotherapy historical data14,15,16
  • Equivalent to low dose rate (LDR)17, 18 and high dose rate (HDR) brachytherapy19
  • Excellent disease-free survival rates at five years for intermediate-risk patients2,3
  • Equal to or higher than conventional radiotherapy historical data20,21

Convenient

The CyberKnife System eases the return to daily life for patients

  • Compared to surgery, this nonsurgical and outpatient procedure does not require general anesthesia, invasive incisions, hospitalization, and long recovery time
  • Compared to brachytherapy, this minimally invasive procedure eliminates the inconvenience and risk associated with radioactive seed or catheter implants
  • Compared to conventional radiotherapy, this treatment is completed in only 4-5 sessions instead of the 30-40 sessions which offers convenience to patients and cost savings to healthcare providers22,23,24