Results from the first randomized phase III clinical trial to directly compare MRI-guided stereotactic body radiotherapy (SBRT) with the same therapy guided by CT are published in JAMA Oncology. They confirm interim findings presented at the 2022 ASCO Genitourinary (GU) Cancers Symposium in San Francisco.
“MRI guidance offers several advantages over standard CT guidance, most notably the ability to dramatically reduce planning margins, providing more focused treatment with less injury to nearby normal tissues and organs,” said Amar Kishan, M.D., a radiation oncologist at the David Geffen School of Medicine at UCLA and the UCLA Jonsson Comprehensive Cancer Center and the study’s lead author. “MRI technology is more costly than CT, both in terms of upfront equipment expenses and longer treatment times, which is one reason our study set out to determine if MRI-guided technology offers tangible benefits for patients.”
Stereotactic body radiotherapy for prostate cancer usually delivers radiation in five or fewer precisely targeted doses. It is an established and generally well tolerated form of treatment, but it can cause toxicities resulting in urinary, bowel and sexual dysfunction. This clinical trial, Magnetic Resonance Imaging-Guided Stereotactic Body Radiotherapy for Prostate Cancer (MIRAGE), was led at UCLA and included 154 analyzable patients with prostate cancer who were randomized to either a CT-guidance arm (76 patients) or an MRI-guidance arm (78 patients).
A unique aspect of the study was its inclusion of outcome measures assessed by patients as well as physicians. From both perspectives, MRI-guided therapy was associated with fewer side effects and better quality of life over at least three months of follow-up.
“In this trial, we demonstrated that the reduction in treatment volumes facilitated by MRI guidance leads to a significant reduction in moderate physician-scored toxicity and to a reduction in the proportion of patients noting significant decrements in patient-reported outcome metrics in the near term,” said Dr. Kishan. “Although additional studies will need to confirm these benefits over time, we’re hopeful that these results will lead to better outcomes for men with prostate cancer.”
The 2-millimeter margin used with MRI-guidance in the trial is narrower than has been used in any previous large study. Unlike CT, MRI technology can monitor prostate motion directly, and it offers improved soft tissue contrast, improving the accuracy of alignment prior to radiation.
In addition to Dr. Kishan, authors include Ting Martin Ma, Michael Steinberg, James M. Lamb, Maria Casado, Holly Wilhalme, Daniel A. Low, Ke Sheng, Sahil Sharma, Nicholas G. Nickols, Jonathan Pham, Yingli Yang, Yu Gao, John Neylon, Vincent Basehart, and Minsong Cao, all of UCLA.
This study was supported by grants from the U.S. Department of Defense (No. PC210066, Kishan), the American Society for Radiation Oncology (Kishan), the Prostate Cancer Foundation (Kishan), and the Jonsson Comprehensive Cancer Center (Kishan), the generous funding from the Bershad family, DeSilva family, and McCarrick family. The funding support had no role in the design, conduct, or analysis of the study.
Potential Conflict Statement
Dr. Kishan reports consulting fees and speaking honoraria from Varian Medical Systems, ViewRay, and Intelligent Automation; low value stock in ViewRay; and research funding from ViewRay outside the scope of the MIRAGE trial. Dr. Kishan also reports research support from Janssen and Point Biopharma outside the scope of the current work. Dr. Steinberg reports receiving consulting fees from ViewRay, Inc. outside the submitted work. The MIRAGE trial was not sponsored by ViewRay, nor did ViewRay provide any input provided for design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Article: Magnetic Resonance Imaging-Guided vs Computed Tomography-Guided Stereotactic Body Radiotherapy for Prostate Cancer: the MIRAGE Randomized Clinical Trial; JAMA Oncol January 12, 2023, DOI: 10.1001/jamaoncol.2022.6558
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