Part I | Chapter 6 118 difficulty in getting or maintaining an erection (if sexually active) increased from 21.7% at baseline to 24.6% at 3 months, 25.5% at 6 months, and 31.6% at 12 months FU (Figure 3). The QLQ-C30 functioning and symptom scales showed no difference in median scores between baseline and 3, 6, and 12 months FU. There was, however, a decline (improvement) in the median fatigue domain score from 11.1 (IQR: 0.0-22.2) at baseline to 0.0 (IQR: 0.0-22.2; p = 0.025; ES = 0.20) at 12 months FU (Table S3-5 in Supplementary C). Discussion In this paper, we have reported the first 12-month results of 425 prostate cancer patients treated with 5 x 7.25 Gy on 1.5 T MR-Linac within the international, multicentre MOMENTUM study. These first results show that treatment is effective and safe, with a significant and steep decline in PSA level up to 12 months FU and only one case of grade 3 GU toxicity and no grade ³ 3 GI toxicity. A transient but significant increase in cumulative GU and GI toxicity was reported at 3 months FU and a significant increase in ED toxicity for non-ADT patients was reported at 12 months FU. Compared to baseline, no significant changes in the QLQ-PR25 bowel and sexual activity domain scores were observed at 3, 6, and 12 months FU. For the QLQ-PR25 urinary domain, a significant deterioration with a small effect size was reported from baseline to 3, 6, and 12 months and a significant decline in the sexual functioning domain score at 6 and 12 months FU was observed, with a large and moderate effect size, respectively. Figure 3 – Distribution of answers to QLQ-PR25 question: “Did you have difficulty getting or maintaining and erection?” for non-ADT patients only. The question should only be answered if the recipient has been sexually active over the last 4 weeks (at the moment of filling out the QLQ-PR25 questionnaire).
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