ViewRay: Phase III Interim Data Show Superiority Of MRIdian MRI-guidance In SBRT For

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(RTTNews) – ViewRay Inc. (VRAY) said interim data from the single center Phase III randomized MIRAGE trial, which compared MRIdian MRI-guided vs. CT-guided Stereotactic Body Radiotherapy or SBRT for localized prostate cancer, signaled superiority of MRIdian MRI-guided SBRT with a significant reduction in acute grade greater than or equal to 2 GU toxicity in men receiving MRI-guided SBRT over those receiving CT-guided SBRT.

Acute grade greater than or equal to 2 GU toxicity can include adverse events range from frequent, urgent, or painful urination to pelvis pain, bladder spasms, or blood in the urine. Acute grade greater than or equal to 2 GI toxicity can include adverse events ranging from diarrhea, discharge, or rectal/abdominal pain to abdominal distention or obstruction.

The company noted that the study protocol was amended to reduce the projected sample size from 300 to 154, requiring half the number of patients while still maintaining 89 percent power to demonstrate superiority. Accrual of the MIRAGE trial (NCT04384770) was completed as of October 2021 and a final analysis for the primary endpoint is anticipated in early 2022.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.



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