Acute Toxicity of Ultrahypofractionation Compared to Moderate Hypofractionation in Prostate Cancer Treatment – a Randomized Trial

To report on the early toxicities and quality of life (QOL) of localized prostate cancer radiotherapy in a randomized trial comparing moderate hypofractionation (MHF) to ultrahypofractionation (UHF) MATERIALS AND METHODS: Intermediate to high risk localized prostate cancer patients were randomized to radiotherapy with MHF (70 Gy in 28 daily fractions) or UHF (36.25 Gy in 5 weekly fractions). Early toxicities (CTCAE and RTOG/SOMA scales) and patient reported QOL (EPIC questionnaire) were analysed when all patients had a minimum of 6 months follow-up.Eighty participants were randomized but two withdrew from radiotherapy. Analysis was done on 78 patients. The two arms were balanced in key patient and disease characteristics except for a statistically worse baseline urinary function in the UHF arm (IPSS > 7: 68% vs 36% p = 0.004). There are no statistically significant differences between the two arms in Grade 3 or Grade 2 toxicities: ≥ Grade 3 - MHF 8%, UHF 2% (p=0.235); ≥ Grade 2 MHF 36%, UHF 24% (p=0.235). There are also no significant differences in percentages of patients with a "minimal important change" of QOL in the Incontinence (MHF 36%, UHF 33% p =0.746), Irritative/Obstructive (MHF 56%, UHF 74% p=0.074) or Bowel domains (MHF 58%, UHF 52% p=0.508) on the EPIC questionnaire.UHF radiotherapy for prostate cancer is well tolerated and there were no significant differences in toxicities and quality of life changes between UHF and MHF up to six months after treatment in the current trial.