Late toxicities of prostate cancer radiotherapy with and without hydrogel SpaceAOR insertion.

To investigate whether the implantation of a hydrogel spacer (SpaceOAR) reduces long-term rectal toxicity for prostate cancer patients treated with intensity-modulated radiotherapy (IMRT).Patients with localised prostate cancer treated with 81 Gy in 45 fx of IMRT over 9 weeks were retrospectively compared: 65 patients with SpaceOAR and 56 patients without SpaceOAR. Planning aims restricted rectal doses to V40 Gy < 35%, V65 Gy < 17%, V75 Gy < 10%. Toxicities were evaluated between 3 months and 3 years after the completion of radiotherapy and were based on the common terminology criteria for adverse events (CTCAE) assessment tool for diarrhoea, haemorrhoids, faecal incontinence and proctitis.The cumulative incidence of low-grade diarrhoea (G1) was significantly higher in the non-SpaceOAR group (21.4% vs 6.2%; P = 0.016). The cumulative incidence of proctitis (grades G1 and G2) was also higher in the non-SpaceOAR group (26.7% vs 9.2%; P = 0.015); the cumulative incidence of G2 proctitis was higher in the latter group (P = 0.043). There were no differences between the treatment groups for cumulative incidences of faecal incontinence and/or haemorrhoids. Three years after IMRT, diarrhoea and proctitis were higher in the non-SpaceOAR group, without reaching statistical significance. This finding was unchanged after correcting for baseline symptoms.SpaceOAR is of benefit in reducing the cumulative incidence of low-grade diarrhoea and proctitis for up to 3 years after intensity-modulated radiotherapy.