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

INTRODUCTION: 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). METHODS: 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. RESULTS: 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. CONCLUSION: SpaceOAR is of benefit in reducing the cumulative incidence of low-grade diarrhoea and proctitis for up to 3 years after intensity-modulated radiotherapy.

Can a peri-rectal hydrogel spaceOAR programme for prostate cancer intensity-modulated radiotherapy be successfully implemented in a regional setting?

INTRODUCTION: The aim of this study was to investigate whether the implementation of a hydrogel spacer (SpaceOAR) programme for patients treated with 81 Gy prostate intensity-modulated radiotherapy (IMRT) in a regional setting can reduce rectal doses and toxicity. METHODS: In this retrospective study, 125 patients with localised prostate cancer treated between April 2014 (programme commencement) and June 2015 were compared: 65 with SpaceOAR (inserted by five different urologists) and 60 patients treated over the same time period without SpaceOAR. Patients were treated with 81 Gy in 45Fx of IMRT over 9 weeks. Planning aims included restricting rectal doses to V40 Gy < 35%, V65 Gy < 17%, V75 Gy < 10%. Acute toxicity was assessed weekly during radiotherapy and at 12 weeks. RESULTS: Rectal volume parameters were all significantly lower in the SpaceOAR group, with an associated reduction in acute diarrhoea (13.8% vs 31.7%). There were no significant differences in the very low rates of acute and late faecal incontinence or proctitis, however, there was a trend towards increased haemorrhoid rate in the SpaceOAR group (11.7% vs 3.1%, P = 0.09). CONCLUSION: A SpaceOAR programme in a regional setting with urologists performing low volumes of insertions (<1 per month on average) is of clinical benefit, and was associated with significantly lower radiation doses to the rectum and lower rates of acute diarrhoea.