Noninferiority of hypofractionated versus conventionally fractionated postprostatectomy radiotherapy for genitourinary and gastrointestinal symptoms

The phase 3 noninferiority NRG-GU003 randomized trial, at 93 centers in the US and Canada, compared hypofractionated postprostatectomy radiotherapy (HYPORT) with conventionally fractionated postprostatectomy radiotherapy (COPORT) for the endpoint genitourinary (GU) and gastrointestinal (GI) symptoms. In this randomized trial of 296 patients, HYPORT was associated with greater patient-reported GI symptoms compared with COPORT at the completion of radiotherapy; however, this difference resolved within 6 months. HYPORT compared with COPORT was not associated with significantly higher patient-reported GU or GI symptoms 1 or 2 years after radiotherapy. The authors conclude that HYPORT is noninferior to COPORT in terms of patient-reported late toxic effects, and is a new acceptable practice standard (visual abstract).