To evaluate the clinical utility of deformable image registration (DIR) in the early prediction of rectal bleeding in prostate cancer radiotherapy. 240 images (24 plan-CT and 216 pretreatment cone-beam CT (CBCT)) from 24 prostate adenocarcinoma patients were prospectively acquired during the first fifteen fractions of their real treatment (76 Gy in 38 fractions). After correlation with a deformable image registration (DIR), doses of a virtual treatment plan (57.3 Gy in 15 fractions) were mapped from each CBCT to the plan-CT, allowing the identification of patients who have exceeded the dose limitation for 50% of the rectum (R50). We classified patients according to whether or not they had fulfilled the R50 constraint and we compared with student t-test their variation rate (VR) = [100 x (dose delivered to R50 - planned dose to R50 / planned dose to R50)] during the first 5 sessions. Using Roc curves, we also studied if during these first fractions a value of VR could reliably predict the risk of not complying with the constraint and therefore the risk of rectal bleeding. 15 patients would have met the R50 limitation and 9 would not. Significant differences in the VR between both subgroups have been found in fractions 1, 3 and 5 (t = - 3.192, p = 0.008; t = - 5.683, p< 0,001; t = - 5,340, p< 0,001). In fraction 1, a value of VR > 0% would have predicted the risk of rectal overdosage with a sensitivity of 66.7% and a specificity of 73.3%. In fractions 3 and 5, a VR value > 1% would have predicted the risk of rectal overdosage in the same way, with a sensitivity of 100% and a specificity of 93.3%. After a median follow-up of 56.5 months there have been three rectal bleeding cases (with endoscopic confirmation), all of them would have been detected in fraction three with the VR value established as predictive of rectal toxicity. This study demonstrated the clinical utility of DIR in establishing already in fraction 3 a VR value (>1%) that reliably predicts the risk of rectal bleeding, even if we use a different schedule than the one used for its calculation.
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