Online adaptive MRI-guided SBRT showed technical feasibility in intermediate-risk prostate cancer patients.
This Phase 2 non-randomized trial evaluated online adaptive magnetic resonance imaging (MRI)-guided stereotactic body radiation therapy in a population of 54 patients with intermediate-risk prostate cancer. The study design involved 3 parallel single-center trials conducted across 3 different institutes. The intervention utilized escalating doses to the gross tumor volume and de-escalating doses to the prostate clinical target volume using a 0-mm planning target volume margin.
The primary outcome was technical feasibility, defined as an accumulated gross tumor volume D90% greater than 42 Gy on post-treatment MRI in at least 90% of patients. This threshold was reached in 46 of 54 patients, representing 85% of the analyzed cohort. When stratified by institute, the outcome was achieved in 10 of 14 patients (71%) at institute 1 and 18 of 20 patients (90%) at institutes 2 and 3.
Safety and tolerability data were not reported in the study. A key limitation noted was that robust coverage of the gross tumor volume and clinical target volume could not be assured in the absence of a gating strategy. Because the study was non-randomized and lacked a comparator, causal conclusions regarding efficacy cannot be drawn. These results indicate technical feasibility but highlight the need for further investigation in randomized settings.