Things just aren’t working out for the HYPRO trial. To review, HYPRO is one of the several recent trials comparing standard (79 Gy in 39 fractions) and moderately hypofractionated (64.6 Gy in 19 fractions) radiation for prostate cancer. And, in contrast to most of the others, it actually tested for the superiority of the hypofractionated regimen. It wasn’t superior. It also tested the non-inferiority of toxicity between arms. This included physician-graded acute and late toxicity, where late grade ≥3 GU toxicity was actually worse. And now we have patient-reported quality of life outcomes. The threshold for “clinically significant” was set at a ≥5-point change from baseline in the EORTC-QLQ PR25 and for "non-inferiority" at 8% for the upper limit of the confidence interval. That upper limit was exceeded for both GI and GU toxicity despite only small differences in the absolute rate of clinically-significant detriment to QoL. TBL: To add injury to insult, patient-reported toxicity was not technically non-inferior for hypofractionated prostate radiation in HYPRO. | Wortel, Int J Radiat Oncol Biol Phys 2018


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