To compare the acute radiation-induced bowel and bladder toxicities of two hypofractionated radiotherapy (HFRT) regimens in localised prostate cancer (PCa).

This trial consists of patients with histologically confirmed stage T1-T3aN0M0 PCa, a prostate-specific antigen concentration of 40 ng/mL or lower, and Eastern Cooperative Oncology Group performance status of 0–2. Participants were randomly assigned (1:1) to 56 Gy in 16 fractions over 4 weeks (arm A) or 70·2 Gy in 26 fractions over 5 weeks (arm B). Acute bowel and bladder toxicities were assessed using Radiation Therapy Oncology Group criteria.

Between June 2018 and December 2019, 40 patients were randomly assigned to treatment with 4-week (n = 20) and 5-week HFRT (n = 20). In the third month after completion of radiotherapy, the cumulative incidence of acute bowel and bladder toxicities of arms A and B was 20 versus 5% and 70 versus 85%, respectively. The cumulative incidence of grade 2 or worse bowel and bladder toxicities of the 5-week regimen was non-inferior to 4-week HFRT [bowel toxicity: 5% (arm A) versus 5% (arm B), bladder toxicity: 50% (arm A) versus 60% (arm B), p = 0·52).

The 5-week regimen of HFRT is non-inferior to 4-week HFRT in terms of acute bowel and bladder toxicities.