MRI-guided radiotherapy for prostate cancer: the MOMENTUM study 115 Time-point CTCAE Grade (n, %) p-value* Gastrointestinal toxicity 0 1 2 3 Baseline (n = 227) 211 (93.0%) 14 (6.2%) 2 (0.9%) - 3 months (n = 177) 143 (80.8%) 31 (17.5%) 3 (1.7%) - < 0.001 6 months (n = 120) 105 (87.5%) 13 (10.8%) 2 (1.7%) - 0.178 12 months (n = 62) 53 (85.5%) 8 (12.9%) 1 (1.6%) - 0.072 Genitourinary toxicity Baseline (n = 227) 143 (63.0%) 73 (32.2%) 11 (4.8%) - 3 months (n = 177) 78 (44.1%) 66 (37.3%) 32 (18.1%) 1 (0.6%) < 0.001 6 months (n = 120) 77 (64.2%) 34 (28.3%) 9 (7.5%) - 0.503 12 months (n = 62) 38 (61.3%) 16 (25.8%) 8 (12.9%) - 0.803 Erectile dysfunction (non-ADT patients only) Baseline (n = 185) 111 (60.0%) 45 (24.3%) 25 (13.5%) 4 (2.2%) 3 months (n = 145) 98 (67.6%) 34 (23.4%) 11 (7.6%) 2 (1.4%) 0.118 6 months (n = 102) 56 (54.9%) 31 (30.4%) 13 (12.7%) 2 (2.0%) 0.052 12 months (n = 52) 24 (46.2%) 15 (28.8%) 11 (21.2%) 2 (3.8%) 0.034 Figure 1 – Boxplots of PSA level at baseline and follow-up, stratified by androgen deprivation therapy (ADT) use. Table 2 – Physician-reported toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) specified (summary of 17 items) at baseline and 1, 3, 6, and 12 months of follow-up. *For comparison with baseline. Highest grade of toxicity that occurred between 0-3 months, 3-6 months, and 6-12 months. N at risk: baseline: 425; 3 months: 365; 6 months: 313; 12 months: 186. ADT = Androgen deprivation therapy. 6
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